Maharashtra act 023 of 1940 : The drugs and cosmetics act, 1940

GOVERNMENT OF INDIA

MINISTRY OF HEALTH AND FAMILY

WELFARE

(Department of Health)

THE DRUGS AND COSMETICS ACT

AND RULES

THE DRUGS AND COSMETICS ACT, 1940

(23 OF 1940)

st (As amended up to the 31 December, 2016) and

THE DRUGS AND COSMETICS RULES, 1945

st (As amended up to the 31 December, 2016)

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LIST OF ABBREVIATIONS USED

A.O. 1950 ……………………………… For Adaptation of Laws Order, 1950 Cl. …………………………………. . … " Clause

Ins. …………………………………….. " Inserted

P. ……………………………………… " Page

Pt. ……………………………………… " Part

Reg. ………………………………........ " Regulation

Rep. …………………………………… " Repealed

S. ……………………………………… " Section

Sch. ……………………………………. " Schedule

Sec. ………………………………......... " Section

Subs. …………………………………… " Substituted

w.e.f. …………………………………… " With effect from

CONTENTS

Pages The Drugs and Cosmetics Act, 1940 (23 of 1940) …………. 1−30 The Drugs and Cosmetics Rules, 1945 ……. . . ……………... 31−546

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THE DRUGS AND COSMETICE ACT, 1940

CHAPTER I

INTRODUCTORY

Sections

1. Short title, extent and commencement.

2. Application of other laws not barred.

3. Definitions. 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir.

4. Presumption as to poisonous substances.

CHAPTER II

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY

AND THE DRUGS CONSULTATIVE COMMITTEE

5. The Drugs Technical Advisory Board.

6. The Central Drugs Laboratory.

7. The Drugs Consultative Committee. 7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.

CHAPTER III

IMPORT OF DRUGS AND COSMETICS

8. Standards of quality.

9. Misbranded drugs. 9A. Adulterated drugs. 9B. Spurious drugs. 9C. Misbranded cosmetics. 9D. Spurious cosmetics.

10. Prohibition of import of certain drugs or cosmetics. 10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.

11. Application of law relating to sea customs and powers of Customs officers.

12. Power of Central Government to make rules.

13. Offences.

14. Confiscation.

15. Jurisdiction.

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Drugs and Cosmetics Act, 1940

CHAPTER IV

MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND

COSMETICS

Sections

16. Standards of quality.

17. Misbranded drugs. 17A. Adulterated drugs. 17B. Spurious drugs. 17C. Misbranded cosmetics. 17D. Spurious cosmetics.

18. Prohibition of manufacture and sale of certain drugs and cosmetics.

18A. Disclosure of the name of the manufacturer, etc. 18B. Maintenance of records and furnishing of information.

19. Pleas.

20. Government Analysts.

21. Inspectors.

22. Powers of Inspectors.

23. Procedure of Inspectors.

24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept.

25. Reports of Government Analysts.

26. Purchaser of drug or cosmetic enabled to obtain test or analysis. 26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.

27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.

27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.

28. Penalty for non-disclosure of the name of the manufacturer, etc. 28A. Penalty for not keeping documents, etc., and for non-disclosure of information.

28B. Penalty for manufacture, etc. of drugs or cosmetics in contravention of section 26A.

29. Penalty for use of Government Analyst's report for advertising.

30. Penalty for subsequent offences.

31. Confiscation. 31A. Application of provisions to Government departments.

32. Cognizance of offences. 32A. Power of Court to implead the manufacturer, etc.

33. Power of Central Government to make rules. 33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.

CHAPTER IV A

PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS

33B. Application of Chapter IV A.

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Drugs and Cosmetics Act, 1940

Sections

33C. Ayurvedic, Siddha and Unani Drugs Technical Advisory Board.

33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.

33E. Misbranded drugs.

33EE. Adulterated drugs.

33EEA. Spurious drugs.

33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs.

33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs.

33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest.

33F. Government Analysts.

33G. Inspectors.

33H. Application of provisions of sections 22, 23, 24 and

25.

33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drugs in contravention of this Chapter.

33J. Penalty for subsequent offences.

33K. Confiscation.

33L. Application of provisions to Government departments. 33M. Cognizance of offences.

33N. Power of Central Government to make rules. 33O. Power to amend First Schedule.

CHAPTER V

MISCELLANEOUS

33P. Power to give directions.

34. Offences by companies. 34A. Offences by Government departments. 34AA. Penalty vexatious search or seizure.

35. Publication of sentences passed under this Act.

36. Magistrate's power to impose enhanced penalties. 36A. Certain offences to be tried summarily.

37. Protection of action taken in good faith.

38. Rules to be laid before Parliament.

THE FIRST SCHEDULE.

THE SECOND SCHEDULE.

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1 Drugs and Cosmetics Act, 1940

THE DRUGS AND COSMETICS ACT, 1940

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(23 OF 1940)

[10th April, 1940.]

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An Act to regulate the import, manufacture, distribution and sale of drugs [and cosmetics];

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WHEREAS it is expedient to regulate the [import, manufacture, distribution and sale] of drugs [and cosmetics];

AND WHEREAS the Legislature of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935 (26 Geo. 5, c.2), in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act; It is hereby enacted as follows:-

CHAPTER I

INTRODUCTORY

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1. Short title, extent and commencement.⎯ (1) This Act may be called the Drugs [and Cosmetics] Act, 1940.

(2) It extends to the whole of India⁴[ * * *].

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(3) It shall come into force at once; but Chapter III shall take effect only from such date as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall

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take effect in a particular State only from such date as the State Government may, by like notification, appoint in this behalf:

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[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date¹⁰after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this behalf.]

2. Application of other laws not barred.- The provisions of this Act shall be in addition to and not in derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for the time being in force.

3. Definitions.—In this Act, unless there is anything repugnant in the subject or context,

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[(a) "⁸[Ayurvedic, Siddha or Unani] drug" includes all medicines intended for internal or external use

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for or in the diagnosis, treatment, mitigation or prevention of [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative

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books of [Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]

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[(aa) "the Board" means—

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(i) in relation to [Ayurvedic, Siddha or Unani] drug, the [Ayurvedic, Siddha and Unani Drugs Technical Advisory Board] constituted under section 33C; and

(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted under section 5;]

1. For Statement of Object and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for the Report of the Select Committee, see ibid., p. 143. The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government Notification No. 3358-LSG., dated the 25^th August, 1941.

2. Ins. by Act 21 of 1962, s. 2 (w.e.f. 27-7-1964).

3. Subs. by the A.O. 1950, for certain words.

4. The words "except the State of Jammu and Kashmir" omitted by Act 19 of 1972, s .2. (w.e.f. 31-5-1972). 5 1 st April, 1947; see Notifn. No. F. 28 (10) (3) 45-H (1), dated the 2^nd September 1946, Gazette of India, 1946, Pt. I, p.1349. Chapter IV came into force in the States of Delhi, Ajmer and Coorg on the 1^st April, 1947, see ibid., Chapters III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1 st April, 1953, vide Notification No. S.R.O. 663, dated the 30^th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451.

Chapter IV came into force in the Union territory of Dadra and Nagar Haveli w.e.f. 1^st August, 1968, see Notification No. ADM/Law/117(74), dated the 20^th July, 1968, Gazette of India, Pt. III, Sec. 3, p.128. The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, s. 2 and Sch. I; to Pondicherry by Reg. 7 of 1963. s. 3 and Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and Sch. and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965. s.3 and Sch.

6. Added by Act 19 of 1972, s. 2.

7 Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).

8 . Subs. by Act 68 of 198 2, s. 2, for certain words (w.e.f. 1-2-198 3).

9. Clause. (a) was relettered as cl. (aa) by Act 13 of 1964 s. 2, (w.e.f. 15-9-1964).

10. 24^th August, 1974, vide notifin no. S.O. 2185, dt. 9^thAugust, 1974.

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Drugs and Cosmetics Act, 1940

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[ [(aaa)] "cosmetic" means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component

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of cosmetic [* * *] ;]

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[(b) "drug" includes—

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[(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;]

(ii) such substances (other than food) intended to affect the structure or any function of the human

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body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;]

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[(iii) all substances intended for use as components of a drug including empty gelatin capsules; and

(iv) such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]

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[(c) "Government Analyst" means—

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(i) in relation to [Ayurvedic, Siddha or Unani] drug, a Government Analyst appointed by the Central Government or a State Government under section 33F; and

(ii) in relation to any other drug or cosmetic, a Government Analyst appointed by the Central Government or a State Government under section 20;]

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[* * * * *]

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[(e) "Inspector" means—

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(i) in relation to [Ayurvedic, Siddha or Unani] drug, an Inspector appointed by the Central Government or a State Government under section 33G; and

(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21;]

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[ [(f)] "manufacture" in relation to any drug [or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise

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treating or adopting any drug [or cosmetic] with a view to its [sale or distribution] but does not

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include the compounding or dispensing [of any drug, or the packing of any drug or cosmetic,] in the ordinary course of retail business; and "to manufacture" shall be construed accordingly;] 17 [(g)] "to import", with its grammatical variations and cognate expressions means to bring into 18 [India];

1. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).

2. Clause. (aa) relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).

3. omitted by Act 68 of 1982, s.3, certain words.

4. Subs. by Act 11 of 1955, s. 2, for cl. (b).

5. Subs. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983).

6. Subs. by Act 13 of 1964, s. 2, for "vermins" (w.e.f. 15-9-1964).

7. Ins. by Act 68 of 1982, s.3 (w.e.f. 1-2-1983). The Central Government has specified (vide S.O. 1468 (E), dated 6-10-2005) the following devices intended for external or internal use in human beings or drugs with immediate effect, namely:-

(i) Cardiac Stents (ii) Drug Eluding Stents (iii) Catheters (iv) Intra Ocular Lenses (v) I.V. Cannulac (vi) Bone Cements

(vii) Heart Valves (viii) Scalp Vein Set (ix) Orthopaedic Implants (x) Internal Prosthetic Replacements

8. Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f.15-9-1964).

9. Subs. by Act 68 of 1982 s.2, for "Ayurvedic (including sidda) or Unani" (w.e.f. 1-2-1983).

10. Cl. (d) omitted by Act 19 of 1972, s. 3. 15. Subs. by Act 68 of 1982, s.3, for "sale and distribution"(w.e.f. 1-2-1983).

11. Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964). 16. Subs. by Act 21 of 1962 s. 4, for "or the packing of any drug".

12. Ins. by Act 11 of 1955, s. 2. 17. Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).

13. Clause. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).

14. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964). 18. Subs. by Act 3 of 1951, s. 3 and Sch., for "the States".

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Drugs and Cosmetics Act, 1940

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[ [(h)] "patent or proprietary medicine" means,—

(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);

(ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;]

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[ [(i)] "prescribed" means prescribed by rules made under this Act.]

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[* * * * *]

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[3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir.—Any reference in this Act to any law which is not in force, or any functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed as a reference to the corresponding law in force, or to the corresponding functionary in existence, in that State.]

4. Presumption as to poisonous substances.—Any substance specified as poisonous by rule made under

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Chapter III or Chapter IV [or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of

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Chapter III or Chapter IV [or Chapter IVA], as the case may be.

CHAPTER II

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABOURATORY

AND THE DRUGS CONSULTATIVE COMMITTEE

5. The Drugs Technical Advisory Board.—(1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act.

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[(2) The Board shall consist of the following members, namely:—

(i) the Director General of Health Services, ex officio, who shall be Chairman; (ii) the Drugs Controller, India, ex officio;

(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;

(iv) the Director of the Central Research Institute, Kasauli, ex officio;

(v) the Director of Indian Veterinary Research Institute, Izatnagar, ex officio;

(vi) the President of Medical Council of India, ex officio;

(vii) the President of the Pharmacy Council of India, ex officio;

(viii) the Director of Central Drug Research Institute, Lucknow, ex officio;

(ix) two persons to be nominated by the Central Government from among persons who are in charge of drugs control in the States;

1. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983).

2. Cls. (c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).

3. Subs. by Act 11 of 1955, s. 2, for cl. (e).

4. Clause. (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, s. 3 and Sch.

5. Ins. by Act 19 of 1972, s. 4 (w.e.f. 31-5-1972).

6. Ins. by Act 13 of 1964, s. 3 (w.e.f. 15-9-1964).

7. Subs. by Act 13 of 1964, s. 4, for sub-section (2) (w.e.f. 15-9-1964).

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Drugs and Cosmetics Act, 1940

(x) one person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college affiliated thereto;

(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto;

(xii) one person to be nominated by the Central Government from the pharmaceutical industry;

(xiii) one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

(xiv) one person to be elected by the Central Council of the Indian Medical Association;

(xv) one person to be elected by the Council of the Indian Pharmaceutical Association;

(xvi) two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government.]

(3) The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re- nomination and re-election:

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[Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the Board.]

(4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.

(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, not exceeding three years, as it may decide, or temporarily for the consideration of particular matters, persons who are not members of the Board.

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

6. The Central Drugs Laboratory.—(1) The Central Government shall, as soon as may be, established a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter:

Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in

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respect of any drug or class of drugs [or cosmetic or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the

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Central Drugs Laboratory in respect of such drug or class of drugs [or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.

(2) the Central Government may, after consultation with the Board, make rules prescribing—

(a) the functions of the Central Drugs Laboratory;

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[* * * * *]

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(d) the procedure for the submission to the said Laboratory [under Chapter IV or Chapter IVA] of

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samples of drugs [or cosmetics] for analysis or test, the forms of Laboratory's reports thereon and the fees payable in respect of such reports;

1. Subs. by Act 13 of 1964, s. 4, for the proviso (w.e.f. 15-9-1964).

2. Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964).

3. Cls. (b) and (c) omitted by Act 11 of 1955, s. 4.

4. Subs. by Act 13 of 1964, s. 5, for "under Chapter IV" (w.e.f. 15-9-1964).

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Drugs and Cosmetics Act, 1940

(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).

7. The Drugs Consultative Committee.—(1) The Central Government may constitute an advisory committee to be called "the Drugs Consultative Committee" to advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity

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throughout [India] in the administration of this Act.

(2) The Drugs Consultative Committee shall consist of two representatives of the Central Government to be nominated by that Government and one representative of each State Government to be nominated by the State Government concerned.

(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.

2 [7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.—Nothing contained in sections 5 and 7 shall apply to³[Ayurvedic, Siddha or Unani] drugs.]

CHAPTER III

4

[IMPORT OF DRUGS AND COSMETICS]

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8. Standards of quality.— [(1) For the purposes of this Chapter, the expression "standard quality"

means—

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(a) in relation to a drug, that the drug complies with the standard set out in [the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic compiles with such standard as may be prescribed].

(2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or

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otherwise amend [the Second Schedule], for the purposes of this Chapter, and thereupon [the Second Schedule] shall be deemed to be amended accordingly.

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[9. Misbranded drugs.—For the purposes of this Chapter a drug shall be deemed to be misbranded—

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.]

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[9A. Adulterated drugs.— For the purposes of this Chapter, a drug shall be deemed to be adulterated.—

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

1. Subs. by Act 3 of 1951, s. 3 and Sch., for "the States".

2. Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964).

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Drugs and Cosmetics Act, 1940

(c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

9B. Spurious drugs.— For the purposes of this Chapter, a drug shall be deemed to be spurious—

(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

9C. Misbranded cosmetics.—For the purposes of this chapter, a cosmetic shall be deemed to be misbranded—

(a) if it contains a colour which is not prescribed; or

(b) if it is not labelled in a prescribed manner; or

(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

9D. Spurious cosmetics.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—

(a) if it is imported under the name which belongs to another cosmetic; or

(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

(c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

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10. Prohibition of import of certain drugs or cosmetics.— From such date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import—

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(a) any drug [or cosmetic] which is not of standard quality; 3 [(b) any misbranded drug 4 [or misbranded or spurious cosmetic;]

1. 1st April, 1947 for cls. (a), (b), (c), (e) and (f) and 1st April 1949 for cl. (d) see Notifn. No.18- 12/46-D (I), dated the 11th February 1947, Gazette of India, 1947, Pt. 1, P. 189 as amended by Notifn. No.F.1-2/48-D (1), dated the 29th September,1948.

1st April, 1953 for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal,Tripura, Vindhya Pradesh and Manipur; vide Notifn. No. S.R.O. 666, dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p.451.

2. Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964).

3. Subs. by Act 21 of 1962, s. 8, for cl. (b) (w.e.f. 27-7-1964).

4. Subs. by Act 68 of 1982, s.7, for "or misbranded cosmetic" (w.e.f. 1-2-1983).

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Drugs and Cosmetics Act, 1940

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[(bb) any [adulterated or spurious] drug;]

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(c) any drug [or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;

4 [(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof⁵[the true formula or list of active ingredients contained in it, together with the quantities thereof;]

(e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;

3 [(ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;]

(f) any drug³[or cosmetic] the import of which is prohibited by rule made under this Chapter:

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis or for personal use:

Provided further that the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality.

6

[* * * * *]

7

[10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]

11. Application of law relating to sea customs and powers of Customs Officers.— (1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of

8

the Sea Customs Act, 1878 (8 of 1878) shall, subject to the provisions of section 13 of this Act, apply in

9

respect of drugs [and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs

10

and officers empowered under that Act to perform the duties imposed thereby on a [Commissioners of

9

Customs] and other officers of Customs, shall have the same powers in respect of such drugs [and cosmetics] as they have for the time being in respect of such goods as aforesaid.

11 10

[(2) Without prejudice to the provisions of sub-sections (1), the [Commissioners of Customs] any officer of the Government authorized by the Central Government in this behalf, may detain any imported

9

package which he suspects to contain any drug [or cosmetic] the import of which is prohibited under this Chapter and shall forthwith report such detention to the Drugs Controller, India, and, if necessary, forward the

9

package or sample of any suspected drug [or cosmetic] found therein to the Central Drugs Laboratory.]

12

12. Power of Central Government to make rules.—(1) The Central Government may, [after consultation with or on the recommendation of the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

1. Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964).

2. Subs. by Act 68 of 1982, s.7, for "adulterated" (w.e.f. 1-2-1983).

3 . Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964).

4. Subs. by Act 11 of 1955, s. 5, for cl. (d).

5. Subs. by Act 68 of 1982, s.7, for certain words (w.e.f. 1-2-1983).

6. Explanation omitted by s.7, ibid. (w.e.f. 1-2-1983).

7. Ins. by s. 8, Act 68 of 1982. (w.e.f. 1-2-1983).

8. Now see the Customs Act, 1962.

9. Ins. by Act 21of 1962, s. 9 (w.e.f. 27-7-1964).

10. Subs. by Act 22 of 1995, s. 83, for "Customs Collector".

11. Subs. by Act 11 of 1955, s. 6, for sub-section (2).

12. Subs. by Act 68 of 1982, s.9, for certain words (w.e.f. 1-2-1983).

12

Drugs and Cosmetics Act, 1940

1

[Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]

(2) Without prejudice to the generality of the forgoing power, such rules may—

2

(a) specify the drugs or classes of drugs [or cosmetics or classes of cosmetics] for the import of

3

which a licence is required, [and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefor and provide for the cancellation, or suspension of such licence in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which the licence is issued is not complied with];

2

(b) prescribe the methods of test or analysis to be employed in determining whether a drug [or cosmetic] is of standard quality;

(c) prescribe, in respect of biological and organometallic compounds, the units or methods of standardization;

4 5

[(cc) prescribe under clause (d) of [section 9A] the colour or colours which a drug may bear or contain for purposes or colouring;]

6

(d) specify the diseases or ailments which an imported drug may not purport or claim [to prevent, cure or mitigate] and such other effects which such drug may not purport or claim to have;

(e) prescribe the conditions subject to which small quantities of drugs, the import of which is otherwise prohibited under this Chapter, may be imported for the purpose of examination, test or analysis or for personal use;

2

(f) prescribe the places at which drugs [or cosmetics] may be imported, and prohibit their import at any other place;

(g) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified imported drug or class of such drug, and prohibit the import of the said drug or class of drug after the expiry of a specified period from the date of manufacture;

2

(h) regulate the submission by importers, and the securing, of samples of drugs [or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis;

(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs²[or cosmetics] sought to be imported, the procedure of officers of Customs in dealing with such evidence, and the manner of storage at places of import of drugs²[or cosmetics] detained pending admission;

(j) provide for the exemption, conditionally or otherwise, from all or any of the provisions of

13

Drugs and Cosmetics Act, 1940

(n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary medicine containing such drug;

(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs¹[or cosmetic or class of cosmetics].

2 [13. Offences.—(1) Whoever himself or by any other person on his behalf imports, —

(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees;

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both;

(c) any drug or cosmetic in contravention of the provisions of any notification issued under section 10A, shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both;

(2) Whoever having been convicted of an offence—

(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten thousand rupees, or with both;

(b) under clause (b) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both.

(3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provisions of section 11.]

14. Confiscation.—Where any offence punishable under section 13 has been committed, the consignment of the drugs³[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.

4

15. Jurisdiction.—No Court inferior to that [of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under section 13.

CHAPTER IV

MANUFACTURE, SALE AND DISTRIBUTION OF

5

[DRUGS AND COSMETICS]

6

16. Standards of quality.— [(1) For the purposes of this Chapter, the expression "standard quality"

means—

7

(a) in relation to a drug, that the drug complies with the standard set out in [the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]

8

(2) The [Central Government], after consultation with the Board and after giving by notification in the Official Gazette not less than three months' notice of its intention so to do, may by a like notification

7

add to or otherwise amend [the Second Schedule] for the purposes of this Chapter, and thereupon 7[the Second Schedule] shall be deemed to be amended accordingly.

14

Drugs and Cosmetics Act, 1940

1

[17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be misbranded,—

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of betapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

17A. Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated,—

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for the purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug , which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

17C. Misbranded cosmetics.— For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded, --

(a) if it contains a colour which is not prescribed; or

(b) if it is not labelled in the prescribed manner; or

(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

17D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,--

(a) if it is manufactured under a name which belongs to another cosmetic; or

(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

2 [17E Adulterated cosmetics.- For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated,-

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.]

1. Subs. by Act 68 of 1982, s.13, for s.17, 17A and 17B (w.e.f. 1-2-1983).

2. Ins. by Act 26 of 2008, s 2 (w.e.f 10-8-2009)

15

Drugs and Cosmetics Act, 1940

18. Prohibition of manufacture and sale of certain drugs and cosmetics.—From such date¹as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf—

2

(a) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale] or distribute—

2

[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious; 12 [(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;]

3

[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the

2

label or container thereof [the true formula or list of active ingredients contained in it together with the quantities thereof];]

(iv) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims⁴[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

5 [(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;]

(b)⁶[sell, or stock or exhibit or offer for sale,] or distribute any drug⁷[or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

6

(c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or

7

distribute any drug [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:

8

Provided further that the [Central Government] may, after consultation with the Board, by notification in

6

the Official Gazette, permit, subject to any conditions specified in the notification, the [manufacture for sale, or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs not being of standard quality.

9

[* * * * *]

10

[18A. Disclosure of the name of the manufacturer, etc.—Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.]

11

[18B. Maintenance of records and furnishing of information.—Every person holding a licence under clause (c) of section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.]

16

Drugs and Cosmetics Act, 1940

19. Pleas.—(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug

1

[or cosmetic] in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.

2 2

(2) [For the purposes of section 18 a drug shall not be deemed to be misbranded or [adulterated or spurious] or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality] only by reason of the fact that—

(a) there has been added thereto some innocuous substance or ingredient because the same is required

1

for manufacture or preparation of the drug [or cosmetic] as an article of commerce in a state fit for

1

carriage or consumption, and not to increase the bulk, weight or measure of the drug [or cosmetic] or to conceal its inferior quality or other defects; or

4

[* * * * *]

(b) in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it: Provided that this clause shall not apply in relation to any sale or distribution of the drug¹[or cosmetic] occurring after the vendor or distributor became aware of such intermixture.

5 [(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves—

(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof;

(b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section; and

(c) that the drug or cosmetic, while in his possession, was properly stored and remained in the same state as when he acquired it.]

6

[20.Government Analysts.— (1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such

7

areas in the state and in respect of such drugs or [classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it

7

thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or [classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.

(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

8

[(4) No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of this section.]

21. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or State Government, as the case may be.

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or⁹[classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.

17

Drugs and Cosmetics Act, 1940

1

(3) No person who has any financial interest [in the import, manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector under this section.

(4) Every Inspector shall be deemed to be public servant within the meaning of section 21 of the Indian

2

Penal Code (45 of 1860), and shall be officially subordinate to such authority [having the prescribed qualifications,] as the Government appointing him may specify in this behalf.]

3

[22. Powers of Inspectors.—(1) Subject to the provisions of section 23 and of any rules made by the Central Government in this behalf, an Inspector may, within the local limits of the area for which he is appointed,—

4

[(a) inspect,—

(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardising and testing the drug or cosmetic;

(ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed;

(b) take samples of any drug or cosmetic,—

(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;

(ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee;

(c) at all reasonable times, with such assistance, if any, as he considers necessary,--

(i) search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed; or

(ii) enter and search any place in which he has reason to believe that an offence under this Chapter has been, or is being, committed; or

(iii) stop and search any vehicle, vessel or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed,

and order in writing the person in possession of the drug or cosmetic in respect of which the offence has been, or is being, committed, not to dispose of any stock of such drug or cosmetic for a specified period not exceeding twenty days, or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by means of which the offence has been, or is being, committed or which may be employed for the commission of such offence;]

5 4

[(cc) examine any record, register, document or any other material object found [with any person, or in any place, vehicle, vessel or other conveyance referred to in clause (c)], and seize the same if he has reason to believe that it may furnish evidence of the commission of an offence punishable under this Act or the rules made thereunder;]

4

[(cca) require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug or cosmetic in respect of which he has reason to believe that an offence under this Chapter has been, or is being, committed;]

(d) exercise such other powers as may be necessary for carrying out the purposes of this Chapter or any rules made thereunder.

1. Subs. by Act 21 of 1962, s.17, for "in the manufacture, import or sale of drugs" (w.e.f 27-7-1964).

2. Ins. by Act 68 of 1982, s.18 (w.e.f. 1-2-1983).

3. Subs. by Act 11of 1955, s. 11, for s. 22.

4. Subs. by Act 68 of 1982, s.19, for certain words (w.e.f. 1-2-1983).

5. Ins. by Act 35 of 1960, s. 5 (w.e.f. 16-3-1961).

18

Drugs and Cosmetics Act, 1940

1

(2) The provisions of [the Code of Criminal Procedure, 1973 (2 of 1974)] shall, so far as may be, apply to any search or seizure under this Chapter as they apply to any search or seizure made under the

1

authority of a warrant issued under [section 94] of the said Code.

2

[(2A) Every record, register or other document seized under clause (cc) or produced under clause (cca) shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts therefrom certified by that person, in such manner as may be prescribed, have been taken.]

(3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred upon him by or

2

under this Chapter, [or refuses to produce any record, register or other document when so required under clause (cca) of sub- section (1),] he shall be punishable with imprisonment which may extend to three years, or with fine, or with both.]

3

23. Procedure of Inspectors.—(1) Where an Inspector takes any sample of a drug [or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written acknowledgment therefor.

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of

3

any drug [or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form.

3

(3) Where an Inspector takes a sample of a drug [or cosmetic] for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked:

3

Provided that where the sample is taken from premises whereon the drug [or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only:

3

Provided further that where the drug [or cosmetic] is made up in containers of small volume, instead of

3

dividing a sample as aforesaid, the Inspector may, and if the drug [or cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them.

(4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:—

(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis;

(ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug³[or cosmetic];

4 [(iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A.]

(5) Where an Inspector takes any action under clause (c) of section 22,—

3

(a) he shall use all despatch in ascertaining whether or not the drug [or cosmetic] contravenes any of

3

the provisions of the section 18 and, if it is ascertained that the drug [or cosmetic] does not so contravene, forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be necessary for the return of the stock seized;

3 5

(b) if he seizes the stock of the drug [or cosmetic], he shall as soon as may be inform [a Judicial Magistrate] and take his orders as to the custody thereof;

(c) without prejudice to the institution of any prosecution, if the alleged contravention be such that

3

the defect may be remedied by the possessor of the drug [or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.

1. Subs. by Act 68 of 1982, s.19, for "the Code of Criminal Procedure, 1898" (w.e.f. 1-2-1983).

2. Ins. by Act 68 of 1982, s. 19. (w.e.f. 1-2-1983).

19

Drugs and Cosmetics Act, 1940

1

[(6) Where an Inspector seizes any record, register, document or any other material object under clause (cc) of sub- section (1) of section 22, he shall, as soon as may be, inform²[a Judicial Magistrate] and take his orders as to the custody thereof.]

24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. —Every person for the time being in charge of any premises whereon any drug³[or cosmetic] is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, be legally bound to disclose to the Inspector the place where the drug³[or cosmetic] is being manufactured or is kept, as the case may be.

3

25. Reports of Government Analysts.—(1) The Government Analyst to whom a sample of any drug [or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken⁴[and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the sample.

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the

5

sample was taken [or the person whose name, address and other particulars have been disclosed under section 18A] has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.

(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant

3

or the accused, cause the sample of the drug [or cosmetic] produced before the Magistrate under sub- section (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.

(5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4) shall be paid by the complainant or accused as the Court shall direct.

6

26. Purchaser of drug ³[or cosmetic] enabled to obtain test or analysis.—Any person [or any recognised consumer association, whether such person is a member of that association or not,] shall, on application in the prescribed manner and on payment of the prescribed fee, be entitled to submit for test or

3 7

analysis to a Government Analyst any drug [or cosmetic] [purchased by him or it] and to receive a report of such test or analysis signed by the Government Analyst.

8

[Explanation.—For the purposes of this section and section 32, "recognised consumer association"

means a voluntary consumer association registered under the Companies Act, 1956 (1 of 1956) or any other law for the time being in force.]

9

[26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, 11 [regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.]

12 [26B. Powers of Central Government to regulate or restrict, manufacture, etc., of drug in public interest. - Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that a drug is essential to meet the requirements of an emergency arising due to epidemic or natural calamities and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate or restrict the manufacture, sale or distribution of such drug.]

10

[27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.—Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes, —

1. Ins. by Act 35 of 1960, s. 6 (w.e.f. 16-3-1961). 9. Ins. by Act 68 of 1982, s. 21 (w.e.f. 1-2-1983).

2. Subs. by Act 68 of 1982, s. 20, for "a Magistrate" (w.e.f. 1-2-1983). 10. Subs. by Act 68 of 1982 s. 22, for s. 27 (w.e.f. 1-2-1983).

3 . Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964). 11. Sub. by Act 26 of 2008, s 4, for "prohibit" (w.e.f 10-8-2009).

4. Subs. by Act 13 of 1964, s. 17, for certain words (w.e.f. 15-9-1964). 12. Ins. by Act 26 of 2008, sec 5(w.e.f. 10-8-2009).

5. Subs. by Act 13 of 1964 s.17, for "or the said warrantor"(w.e.f. 15-9-1964).

6. Ins. by Act 71 of 1986, s. 2 (w.e.f. 15-9-1987).

7. Subs. by Act 71 of 1986 s. 2, for "purchased by him" (w.e.f. 15-9-1987).

8. Added by Act 71 of 1986 s. 2, (w.e.f. 15-9-1987).

20

Drugs and Cosmetics Act, 1940

(a) any drug deemed to be adulterated under section 17A or spurious under section¹[17B and which] when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be²[punishable with imprisonment for a term which shall not be less than ten years but which may extend to a term of life and with fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more;]

3 [Provided that the fine imposed on and released from, the person convicted under this clause shall be paid, by way of compensation, to the person who had used the adulterated or spurious drugs referred to in this clause.

Provided further that where the use of the adulterated or spurious drugs referred to in this clause has caused the death of a person who used such drugs, the fine imposed on and realised from, the person convicted under this clause, shall be paid to the relative of the person who had died due to the use of the adulterated or spurious drugs referred to in this clause.

Explanation.—For the purposes of the second proviso, the expression "relative" means—

(i) spouse of the deceased person; or

(ii) a minor legitimate son, and unmarried legitimate daughter and a widowed mother; or

(iii) parent of the minor victim; or

(iv) if wholly dependent on the earnings of the deceased person at the time of his death, a son or a daughter who has attained the age of eighteen years; or

(v) any person, if wholly or in part, dependent on the earnings of the deceased person at the time of this death,—

(a) the parent; or

(b) a minor brother or an unmarried sister; or

(c) a widowed daughter-in-law; or

(d) a widowed sister; or

(e) a minor child of a pre-deceased son; or

(f) a minor child of a pre-deceased daughter where no parent of the child is alive; or

(g) the paternal grandparent if no parent of the member is alive.]

(b) any drug—

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or

(ii) without a valid licence as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall⁴[not be less than three year but which may extend to five years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more]:

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of⁵[less than three years and of fine of less than one lakh rupees];

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall⁶[not be less than seven years but which may extend to imprisonment for life and with fine which shall not be less than three lakh rupees or three times the value of the drugs confiscated, whichever is more]:

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of⁷[less than seven years but not less than three years and of fine of less than one lakh rupees];

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years⁸[and with fine which shall not be less than twenty thousand rupees]:

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment impose a sentence of imprisonment for a term of less than one year.

1. Sub. by Act 26 of 2008, s 6(i)(A), for "17B or which" (w.e.f 10-8-2009).

2. Sub. by Act 26 of 2008, s 6(i)(B), for "punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees;" (w.e.f 10-8-2009).

3. Ins. by Act 26 of 2008, s. 6(i)(C) (w.e.f.10-8-2009).

4. Sub. by Act 26 of 2008, s 6(ii)(A), for "not be less than one year but which may extend to three years and with fine which shall not be less than five thousand rupees;" (w.e.f 10-8-2009).

5. Sub. by Act 26 of 2008, s 6(ii)(B),for "less than one year and of fine of less than five thousand rupees;" (w.e.f 10-8-2009).

6. Sub. by Act 26 of 2008, s 6(iii)(A),(w.e.f 10-8-2009).

7. Sub. by Act 26 of 2008, s 6(iii)(B),(w.e.f 10-8-2009). 8. Sub. by Act 26 of 2008, s 6(iv), for "and with fine" (w.e.f 10-8-2009).

21

Drugs and Cosmetics Act, 1940

8 [27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.—Whoever himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale—

9 [(i) any cosmetic deemed to be spurious under section 17D or adulterated under section 17E shall be punishable with imprisonment for a term which may extend to three years and with fine which shall not be less than fifty thousand rupees or three times to value of the cosmetics confiscated, whichever is more;

(ii) any cosmetic other than a cosmetic referred to in clause (i) in contravention of any provisions of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to twenty thousand rupees, or with both.] 1 [28. Penalty for non-disclosure of the name of the manufacturer, etc.—Whoever contravenes the provisions of section 18A²[or section 24] shall be punishable with imprisonment for a term which may extend to one year, or³[with fine which shall not be less than twenty thousand rupees or with both.] 4 [28A. Penalty for not keeping documents, etc., and for non-disclosure of information.—Whoever without reasonable cause or excuse, contravenes the provisions of section 18B shall be punishable with imprisonment for a term which may extend to one year or¹²[with fine which shall not be less than twenty thousand rupees or with both].

28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A.—Whoever himself or by any other person on his behalf manufactures or sells or distributes any drug or cosmetic in contravention of the provisions of any notification issued under section 26A, shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine which may extend to five thousand rupees.]

29. Penalty for use of Government Analyst's report for advertising.—Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report, for the purpose of advertising any drug⁵[or cosmetic], shall be punishable with fine, which may extend to five hundred rupees.

6 7

[30. Penalty for subsequent offences.— [(1) Whoever having been convicted of an offence—

(a) Under clause (b) of section 27, is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be¹⁰[less than seven years but which may extend to ten years and with fine which shall not be less than two lakh rupees]; Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of¹¹[less than seven years and of fine of less than one lakh rupees];

1. Subs. by Act 13 of 1964, s.19, for s. 28 (w.e.f.15-9-1964).

2. Ins. by Act 68 of 1982, s. 23 (w.e.f. 1-2-1983).

3. Subs. by Act 26 of 2008 s. 7. Earlier Subs. by Act 68 of 1982, s.23.

4. Ins. by Act 68 of 1982, s. 24, (w.e.f. 1-2-1983).

5. Ins. by Act 21 of 1962, s. 15 (w.e.f.27-7-1964).

6. Subs. by Act 11 of 1955, s. 14, for s. 30.

7. Subs. by Act 68 of 1982, s. 25, for sub-section (1) (w.e.f. 1-2-1983).

8. Subs. by Act 68 of 1982 s. 22, for s. 27A (w.e.f. 1-2-1983), Earlier s. 27A was inserted by Act 21 of 1962, s 19 (w.e.f. 27-7-1964).

9. Subs. by Act 26 of 2008 s. 7, for clause (i) and (ii) (w.e.f. 10-8-2009).

10. Subs. by Act 26 of 2008 sec. 11(a)(i)(A), for "less than two years but which may extend to six years and with fine which shall not be less than ten thousand rupees";( w.e.f. 10-8-2009)

11 . Subs. by Act 26 of 2008 sec. 11 (a)(i)(B), for "less than two years and of fine of less than ten thousand rupees"; (w.e.f. 10-8-2009).

12. Subs. by Act 26 of 2008 s. 7, for "with fine which may extend to one thousand rupees or with both" (w.e.f. 10-8-2009).

22

Drugs and Cosmetics Act, 1940

(b) under clause (c) of section 27 is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall¹²

[ less than ten years but which may extend to imprisonment for life and with fine which shall not be less than three lakh rupees];

(c) under clause (d) of section 27, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to four years or with fine which shall not be less than¹³[fifty thousand rupees], or with both.] 1 [(1A) Whoever, having been convicted of an offence under section 27A is again convicted under that section, shall be punishable with imprisonment for a term which may extend to two years, or with fine which may extend to²[two thousand rupees], or with both.]

(2) Whoever, having been convicted of an offence under³[* * *] section 29 is again convicted of an offence under the same section shall be punishable with imprisonment which may extend to⁴[two tears, or with fine which shall not be less than ten thousand rupees], or with both.]

5

31. Confiscation.— [(1)] Where any person has been convicted under this Chapter for contravening any such provision of this Chapter or any rule made thereunder as may be specified by rule made in this behalf, the

6

stock of the drug [or cosmetic] in respect of which the contravention has been made shall be liable to

7

confiscation [and if such contravention is in respect of—

8

[(i) manufacture of any drug deemed to be misbranded under section 17, adulterated under section 17A or spurious under section 17B; or

9

(ii) [manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale,] or distribution of any drug without a valid licence as required under clause (c) of section 18; any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation.]

10

[(2) Without prejudice to the provisions contained in sub-section (1) where the Court is satisfied, on the application of an Inspector or otherwise and after such inquiry as may be necessary that the drug or

9

cosmetic is not of standard quality or is a [misbranded, adulterated or spurious drug or misbranded or spurious cosmetic,] such drug or, as the case may be, such cosmetic shall be liable to confiscation.]

11

[31A. Application of provisions to Government departments.—The provisions of this Chapter except those contained in section 31 shall apply in relation to the manufacture, sale or distribution of drugs of any department of Government as they apply in relation to the manufacture, sale or distribution of drugs by any other person.]

32. Cognizance of offence.—¹⁴[(1) No prosecution under this Chapter shall be instituted except by-

1. Ins. by Act 21 of 1962, s. 20 (w.e.f. 27-7-1964).

2 . Subs. by Act 68 of 1982 , s. 2 5, for "one thousand rupees" (w.e.f. 1-2 -1983).

3 . The words and figures "section 28 or" omitted by Act 13 of 1964, s. 26 (w.e.f. 15-9-1964).

4 . Subs. by Act 26 of 2008 sec. 11(b), for "ten years, or with fine, or with both".

5. S. 31 re-numbered as sub-section (1) by Act 35 of 1960, s. 9 (w.e.f. 16-3-1961).

6. Ins. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964).

7. Ins. by Act 13 of 1964, s. 21 (w.e.f. 15-9-1964).

8. Subs. by Act 68 of 1982, s. 26, for cl. (i) (w.e.f. 1-2-1983).

9. Subs. by s. 26, ibid., for certain words (w.e.f. 1-2-1983).

10. Sub-section (2) ins. by Act 35 of 1960, s. 9 and subs. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964).

11. Ins. by Act 13 of 1964, s. 22 (w.e.f.15-9-1964).

12. Subs. by Act 26 of 2008 sec. 11(a)(ii), for "less than six years but which may extend to ten years and with fine which shall not be less than ten thousand rupees ";( w.e.f. 10-8-2009)

13. Subs. by Act 26 of 2008 sec. 11(a)(iii), for "five thousand rupees "; (w.e.f. 10-8-2009)

14 . Subs. by Act 26 of 2008, sec 12, for sub-section (1) and (2) (w.e.f. 10-8-2009)

23

Drugs and Cosmetics Act, 1940

(a) an Inspector, or

(b) any gazetted Officer of the Central Government or a State Government authorized in writing in this behalf by the Central Government or a State Government by a general or special order made in this behalf by that Government; or

(c) the person aggrieved; or

(d) a recognised consumer association whether such person is a member of that association or not.

(2) Save as otherwise provided in this Act, no court inferior to that of a Court of Sessions shall try an offence punishable under this Chapter.]

(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter.

1

[32A. Power of Court to implead the manufacturer, etc.—Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also concerned in that offence, then, the Court may,

2

notwithstanding anything contained [in sub-sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure,1973 (2 of 1974)] proceed against him as though a prosecution had been instituted against him under section 32.]

3 [32B. Compounding of certain offences.- (1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), any offence punishable under clause (b) of sub-section (1) of Section 13, Section 28 and Section 28A of this Act(whether committed by a company or any officer thereof), not being an offence punishable with imprisonment only, or with imprisonment and also with fine, may, either before or after the instructions of any prosecution, be compounded by the Central Government or by any State Government or any officer authorized in this behalf Central Government or a State Government, on payment for credit to that Government of such sum as that Government may, by rules made in this behalf, specify:

Provided that such sum shall not, in any case, exceed the maximum amount of the fine which may be imposed under this Act for the offences so compounded:

Provided further that in cases of subsequent offences, the same shall not be compoundable.

(2) When the accused has been committed for trial or when he has been convicted and an appeal is pending, no composition for the offences shall be allowed without the leave of the court to which he is committed or, as the case may be, before which the appeal is to be heard.

(3) Where an offence is compounded under sub-section (1), no proccding or further proceeding, as the case may be , shall be taken against the offender in respect of the offences so compounded and the offender, if in custody, shall be released forthwith.]

4 5

33. Power of Central Government to make rules.— [(1) The Central Government may [after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]

1. Ins. by Act 13 of 1964, s. 23 (w.e.f.15-9-1964).

2. Subs. by Act 68 of 1982, s. 28, for certain words (w.e.f. 1-2-1983).

3. Ins. by Act 26 of 2008, s. 13; (w.e.f. 10-8-2009)

4. Subs. by Act 11 of 1955, s. 15, for sub-section (1).

5. Subs. by Act 68 of 1982, s. 29, for certain words (w.e.f. 1-2-1983).

24

Drugs and Cosmetics Act, 1940

(2) Without prejudice to the generality of the foregoing power, such rules may—

1

(a) provide for the establishment of laboratories for testing and analysing drugs [or cosmetics];

(b) prescribed the qualifications and duties of Government Analysts and the qualifications of Inspectors;

1

(c) prescribe the methods of test or analysis to be employed in determining whether a drug [or cosmetic] is of standard quality;

(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

2 3

[(dd) prescribe under clause (d) of [section 17A] the colour or colours which a drug may bear or contain for purposes of colouring;]

4 [(dda) prescribe under clause (d) of section 17E the colour or colours which a cosmetic may bear or contain for purposes of colouring];

6

(e) prescribe the forms of licences [for the manufacture for sale or for distribution], for the sale

1

and for the distribution of drugs or any specified drug or class of drugs [or of cosmetics or any specified cosmetic or class of cosmetics], the form of application for such licences, the conditions

3

subject to which such licences may be issued, the authority empowered to issue the same [, the

3

qualification of such authority] and the fees payable therefor [and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with;]

3

[(ee) prescribe the records, registers or other documents to be kept and maintained under section 18B;

(eea) prescribe the fees for the inspection (for the purposes of grant or renewal of licence) of premises, wherein any drug or cosmetic is being or is proposed to be manufactured; (eeb) prescribe the manner in which copies are to be certified under sub-section (2A) of section 22;]

5

(f) specify the diseases or ailments which a drug may not purport or claim [to prevent, cure or mitigate]

and such other effects which a drug may not purport or claim to have;

(g) prescribe the conditions subject to which small quantities of drugs may be manufactured for the purpose of examination, test or analysis;

1. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).

2. Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964).

3. Ins. by Act 68 of 1982, s. 29 ( w.e.f. 1-2-1983).

4. Ins. by Act 26 of 2008, s. 14(i) (w.e.f. 10-8-2009)

5. Subs. by Act 11 of 1955, s. 15, for "to cure or mitigate".

6. Subs. By Act 68 of 1982, s. 29 ( w.e.f. 1-2-1983).

25

Drugs and Cosmetics Act, 1940

(h) require the date of manufacture and the date of expiry of potency to be clearly or truly stated on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry of the date of potency;

(i) prescribe the conditions to be observed in the packing in bottles, packages, and other

1 2

containers of drugs [or cosmetics], [including the use of packing material which comes into direct contact with the drugs] and prohibit the sale, stocking or exhibition for sale, or distribution of drugs

1

[or cosmetics] packed in contravention of such conditions;

(j) regulate the mode of labelling packed drugs¹[or cosmetics], and prescribe the matter which shall or shall not be included in such labels;

(k) prescribe the maximum proportion of any poisonous substance which may be added or contained in any drug, prohibit the manufacture, sale or stocking or exhibition for sale, or distribution of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder;

(l) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any patent or proprietary medicine containing such drug;

3

[****]

4 5

[(n) prescribe the powers and duties of Inspectors [and the qualifications of the authority to

6

which such Inspectors shall be subordinate] and [specify the drugs or classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed;]

(o) prescribe the forms of report to be given by Government Analysts, and the manner of application for test or analysis under section 26 and the fees payable therefor;

7

[(p) specify the offences against this Chapter or any rule made thereunder in relation to which an order of confiscation may be made under section 31;⁸[****]]

(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs 1[or cosmetic or class of cosmetics];⁹[and]

10 [(r) sum which may be specified by the Central Government under section 32-B.] 11 [****]

12 [33A. Chapter not to apply to 13 [Ayurvedic, Siddha or Unani] drugs.—Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to¹³[Ayurvedic, Siddha or Unani] drugs.]

14

[CHAPTER IVA

13

PROVISIONS RELATING TO [AYURVEDIC, SIDDHA AND UNANI] DRUGS

13

33B. Application of Chapter IVA.—This Chapter shall apply only to [Ayurvedic, Siddha and Unani] drugs.

15

33C. [Ayurvedic, Siddha and Unani Drugs Technical Advisory Board].—(1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified

15

therein, constitute a Board (to be called the [Ayurvedic, Siddha and Unani Drugs Technical Advisory Board]) to advise the Central Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter.

(2) The Board shall consist of the following members, namely:—

26

Drugs and Cosmetics Act, 1940

(i) the Director General of Health Services, ex officio;

(ii) the Drugs Controller, India, ex officio; 1 [(iii) the principal officer dealing with Indian systems of medicine in the Ministry of Health, ex officio;]

(iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio;

(v) one person holding the appointment of Government Analyst under section 33F, to be nominated by the Central Government;

(vi) one Pharmacognocist to be nominated by the Central Government;

(vii) one Phyto-chemist to be nominated by the Central Government; 2 [(viii) four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee;]

(ix) one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government;

(x) one teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWA-SAZI, to be nominated by the Central Government;

3 [(xi) one teacher in Gunapadam, to be nominated by the Central Government;

(xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government;

(xiii) three persons, one each from among the practitioners of Ayurvedic, Siddha and Unani Tibb system of medicine, to be nominated by the Central Government.]

(3) The Central Government shall appoint a member of the Board as its Chairman.

(4) The nominated members of the Board shall hold office for three years but shall be eligible for renomination.

(5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it.

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

4 [33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.—(1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.

(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.

(3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its own procedure.

33E. Misbranded drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drugs shall be deemed to be misbranded—

1. Subs. by Act 68 of 1982, s. 30, for cl. (iii) (w.e.f. 1-2-1983).

2. Subs. by Act 68 of 1982, s. 30, for cl. (viii) (w.e.f. 1-2-1983).

3. Subs. by Act 68 of 1982, s. 30, for cls. (xi) and (xii) (w.e.f. 1-2-1983).

4. Subs. by Act 68 of 1982, s. 31, for ss. 33D and 33E (w.e.f. 1-2-1983).

27

Drugs and Cosmetics Act, 1940

(a) if it is so coloured, coated, powered or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

33EE. Adulterated drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be adulterated,—

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength. Explanation.—For the purpose of clause (a), a drug shall not be deemed to consist, in whole or in part, of any decomposed substance only by reason of the fact that such decomposed substance is the result of any natural decomposition of the drug:

Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health.

33EEA. Spurious drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious—

(a) if it is sold, or offered or exhibited for sale, under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by any other drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs.—No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.

33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drug.—From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall—

(a) manufacture for sale or for distribution—

(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs;

(ii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it; and

28

Drugs and Cosmetics Act, 1940

(iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder;

(b) sell, stock or exhibit or offer for sale or distribute, any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder;

(c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority:

Provided that nothing in this section apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients:

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis.

33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest.—Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayruvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.]

33F. Government Analysts.—(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.

(2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

1 [(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section.]

33G. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions, limitations or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be prescribed.

(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be an Inspector under this section.

(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code (45 of 1860) and shall be officially subordinate to such authority as the Government appointing him may specify in this behalf.

33H. Application of provisions of sections 22, 23, 24 and 25.—The provisions of sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to the modification that the references to "drug" in the said section, shall be construed as references to²["Ayurvedic, Siddha or Unani] drugs".

3 [33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention of this Chapter —Whoever himself or by any other person on his behalf—

(1) manufactures for sale or for distribution,—

1. Ins. by Act 68 of 1982, s. 32 (w.e.f.1-2-1983).

29

Drugs and Cosmetics Act, 1940 1 [(a) Any Ayurvedic, Siddha or Unani drug -

(i) deemed to be misbranded under section 33E,

(ii) deemed to be adulterated under section 33EE, or

(ii) without a valid licence as required under clause (c) of section 33EEC, shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more;]

(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than²[fifty thousand rupees or three times the value of the drugs confiscated, whichever is more]:

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than²[fifty thousand rupees or three times the value of the drugs confiscated, whichever is more]; or

3 [(c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of any notifications issuedunder Section 33-EED shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to fifty thousand rupees or three times the value of the drugs confiscated, whichever is more.]

(2) contravenes any other provisions of this Chapter or of section 24 as applied by section 33H or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to⁴[six months and with fine which shall not be less than ten thousand rupees.]

5 [33J. Penalty for subsequent offences.—Whoever having being convicted of an offence,—

(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to two years and with fine which shall not be less than⁶[fifty thousand rupees or three times the value of the drugs confiscated, whichever is more];

(b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than⁷[one lakh rupees or three times the value of the drugs confiscated, whichever is more:]

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than⁷[one lakh rupees or three times the value of the drugs confiscated, whichever is more;]

1. Sub. by s. 15(a)(i), for clause (a) (w.e.f. 10.08.2008). Clause (a), before substitution, stood as:"(a) Any Ayurvedic, Siddha or Unani drug - (i) deemed to be adulterated under section 33EE, or (ii) without a valid licence as required under clause (c) of section 33EEC, shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than two thousand rupees;"

2. Sub. by Act 26 of 2008, s. 15(a)(ii), for "five thousand rupees" (w.e.f. 10.08.2008)

3. Ins. by Act 26 of 2008, s. 15(a)(iii) (w.e.f. 10.08.2008)

4. Sub. by Act 26 of 2008, s. 15(b) for "three months and with fine which shall not be less than five hundred rupees." (w.e.f. 10.08.2008)

5. Sub by Act 68 of 1982,s.33 for section 33J(w.e.f. 01.02.1983)

6. Sub. by Act 26 of 2008, s. 16(a), for "two thousand rupees" (w.e.f. 10.08.2008)

7 . Sub. by Act 26 of 2008, s. 16(b), for "five thousand rupees" (w.e.f. 10.08.2008)

30

Drugs and Cosmetics Act, 1940

(c) under sub-section (2) of section 33-I is again convicted of an offence under that sub-section, shall be punishable with imprisonment for a term which may extend to⁵[one year and with fine which shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more;]

33K. Confiscation.—Where any person has been convicted under this Chapter, the stock of the 1[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made, shall be liable to confiscation.

6 [33-KA. Disclosure of name of manufacturer etc., -Every person, not being the manufacturer of any Ayurvedic, Siddha or Unani drug or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the Ayurvedic, Siddha or Unani drug.]

6 [33-KB. Maintenance of records and furnishing of information.— Every person holding a licence under clause (c) of section 33-EEC shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act. ]

33L. Application of provisions to Government departments.—The provisions of this Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, sale or distribution of

1

any [Ayurvedic, Siddha or Unani] drug by any department of Government as they apply in relation to the manufacture for sale, sale or distribution of such drug by any other person.

33M. Cognizance of offences.—(1) No prosecution under this Chapter shall be instituted except by an

2

Inspector [with the previous sanction of the authority specified under sub-section (4) of section 33G].

3

(2) No Court inferior to that [of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.

4

33N. Power of Central Government to make rules.—(1) The Central Government may, [after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case, the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.

(2) Without prejudice to the generality of the foregoing power, such rules may—

(a) provide for the establishment of laboratories for testing and analysing¹[Ayurvedic, Siddha or Unani] drugs;

1 . Subs. by Act 68 of 1 982, s. 2, for "Ayurvedic (including Siddha) and Unani" (w.e.f. 1 -2-1 983).

2. Ins. by Act 68 of 1982, s. 34, (w.e.f. 1-2-1983).

3. Subs. by Act 68 of 1982, s. 34, for certain words (w.e.f. 1-2-1983).

4. Subs. by Act 68 of 1982 , s. 35, for certain words (w.e.f. 1-2-1983).

5. Sub. by Act 26 of 2008, s. 16(c), for "six months and with fine which shall not be less than one thousand rupees." (w.e.f. 10.08.2008)

6. Ins. by Act 26 of 2008, s. 17, (w.e.f. 10.08.2008).

31

Drugs and Cosmetics Act, 1940

(b) prescribe the qualification and duties of Government Analysts and the qualifications of Inspectors;

(c) prescribe the methods of test or analysis to be employed in determining whether any¹[Ayurvedic, Siddha or Unani] drug is labelled with the true list of the ingredients which it is purported to contain;

(d) specify any substance as a poisonous substance;

(e) prescribe the forms of licences for the manufacture for sale of¹[Ayurvedic, Siddha or Unani] drugs,²[and for sale of processed Ayurvedic, Siddha or Unani drugs,] the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same and the fees payable therefor;²[and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with];

3 [(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the use of packing material which comes into direct contact with the drugs, regulate the mode of labelling packed drugs and prescribe the matters which shall or shall not be included in such labels;]

(g) prescribe the conditions subject to which small quantities of¹[Ayurvedic, Siddha or Unani] drugs may be manufactured for the purpose of examination, test or analysis;

2 [(gg) prescribe under clause (d) of section 33EE the colour or colours which an Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;

(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33EEB⁷[***];] 8 [(ggb) prescribe the records, registers or other documents to be kept and maintained under section 33 KB; and]

(h) any other matter which is to be or may be prescribed under this Chapter.

33-O. Power to amend First Schedule.—The Central Government, after consultation with the Board and after giving, by notification in the Official Gazette, not less than three months' notice of its intention so to do, may, by a like notification, add to or otherwise amend the First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly.]

4 [CHAPTER V

MISCELLANEOUS

5 [ 6 [33P.] Power to give directions.—The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made thereunder.]

34. Offences by companies.—(1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly:

1 . Subs. by Act 68 of 1 982, s. 2, for certain words (w.e.f. 1 -2-1 983).

2. Ins. by Act 68 of 1982, s. 35, (w.e.f. 1-2-1968).

3. Subs. by Act 68 of 1982, s. 35, for cl. (f) (w.e.f. 1-2-1968).

4. Subs. by Act 11 of 1955, s. 16, for Chapter V. 5^.. Ins. by Act 35 of 1960, s. 11 (w.e.f. 16-3-1961).

6. S. 33A re-numbered as s. 33P by Act 13 of 1964, s. 27 (w.e.f. 15-9-1964).

7 . The word "and" omitted by Act 26 of 2008, sec.18(i) (w.e.f. 10.08.2009)

8. Sub. by Act 26 of 2008, s. 18(ii) (w.e.f. 10.08.2009)

32

Drugs and Cosmetics Act, 1940 Explanation.—For the purposes of this section—

(a) "company" means a body corporate, and includes a firm or other association of individuals; and

(b) "director" in relation to a firm means a partner in the firm.

1 [34A. Offences by Government Departments.—Where an offence under Chapter 1V or Chapter 1VA has been committed by any department of Government, such authority as is specified by the Central Government to be in charge of manufacture, sale or distribution of drugs or where no authority is specified, the head of the department, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this section shall render any such authority or person liable to any punishment provided in Chapter 1V or Chapter 1VA, as the case may be, if such authority or person proves that the offence was committed without its or his knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence.]

2 [34AA. Penalty for vexatious search or seizure.—Any Inspector exercising powers under this Act or the rules made thereunder, who,—

(a) without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or

(b) vexatiously and unnecessarily searches any person; or

(c) vexatiously and unnecessarily seizes any drug or cosmetic, or any substance or article, or any record, register, document or other material object; or

(d) commits, as such Inspector, any other act, to the injury of any person without having reason to believe that such act is required for the execution of his duty,

shall be punishable with fine which may extend to one thousand rupees.]

35. Publication of sentences passed under this Act.— (1) If any person is convicted of an offence under this Act,³[the Court before which the conviction takes place shall, on application made to it by the Inspector, cause] the offender's name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct.

(2) The expenses of such publication shall be deemed to form part of the cost relating to the conviction and shall be recoverable in the same manner as those costs are recoverable.

36. Magistrate's power to impose enhanced penalties.—Notwithstanding anything contained in⁴[***]⁵[the Code of Criminal Procedure, 1973 (2 of 1974)] it shall be lawful for⁶[any Metropolitan Magistrate or any Judicial Magistrate of the first class] to pass any sentence authorised by this Act in excess of his powers under⁴[* * *] the said Code.

7 [36A. Certain offences to be tried summarily.—Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974),⁸[all offences except the offences triable by the Special Court under Section 36-AB or Court of Sessions under this Act,] punishable with imprisonment for a term not exceeding three years, other than an offence under clause (b) of sub-section (1) of section 33-I, shall be tried in a summary way by a Judicial Magistrate of the first class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of sections 262 to 265 (both inclusive) of the said Code shall, as far as may be, apply to such trial:

Provided that, in the case of any conviction in a summary trial under this section, it shall be lawful for the Magistrate to pass a sentence of imprisonment for a term not exceeding one year:

Provided further that when at the commencement of, or in the course of, a summary trial under this section it appears to the Magistrate that the nature of the case is such that a sentence of imprisonment for a term exceeding one year may have to be passed or that it is, for any other reason, undesirable to try the case summarily, the Magistrate shall, after hearing the parties, record an order to that effect and thereafter recall any witness who has been examined and proceed to hear or rehear the case in the manner provided by the said Code.]

1. Ins. by Act 13 of 1964, s. 28 (w.e.f. 15-9-1964).

2. Ins. by Act 68 of 1982, s. 36 (w.e.f. 1-2-1983).

3. Subs. by Act 68 of 1982, s. 37, for certain words (w.e.f. 1-2-1983).

4 . The words and figures "section 32 of" omitted by Act 13 of 1964 , s. 29 (w.e.f.15-9-1964 ).

5. Subs. by Act 68 of 1982, s. 38, for "the Code of Criminal Procedure, 1898" (w.e.f. 1-2-1983).

6. Subs. by Act 68 of 1982, s. 38, for certain words (w.e.f. 1-2-1983).

7. Ins. by Act 68 of 1982, s. 38, (w.e.f. 1-2-1983).

8 . Sub. by Act 26 of 2008 , s. 19 for all offences (w.e.f. 10.08 .2009)

33

Drugs and Cosmetics Act, 1940

3 [36-AB. Special Courts. - (1) The Central Government, or the State Government, in consultation with the Chief Justice of the High Court, shall, for trial of offences relating to adulterated drugs or spurious drugs punishable under clause (a) and (b) of Section 13, sub-section (3) of Section 22, clause (a) and (c) of Section 27, Section 28, Section 28-A, Section 28-B and clause (b) of sub-section (1) of Section 30 and other offences relating to adulterated drugs or spurious drugs, by notification, designate one or more Courts of Sessions as a Special Court or Special Courts for such area or for such case or class or group of cases as may be specified in the notification.

Explanation.- In this sub-section, "High Court" means the High Court of the State in which a Court of Sessions designated as Special Court was functioning immediately before such designation.

(2) While trying an offence under this Act, a Special Court shall also try an offence, other than an offence referred to in sub-section (1), with which the accused may, under the Code of Criminal Procedure, 1973 (2 of 1974), be charged at the same trial.]

3 [36-AC. Offences to be cognizable and non-bailable in certain cases. -

(1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974)-

(a) every offence, relating to adulterated or spurious drug and punishable under clause (a) and (c) of sub- section (1) Section 13, clause (a) of sub-section (2) of Section 13, subsection (3) of Section 22, clause (a) and

(c) of Section 27, Section 28, Section 28A, 40 Section 28B and sub-section (1) and (2) of Section 30 and other offences relating to adulterated drugs or spurious drugs, shall be cognizable.

(b) no person accused, of an offence punishable under clause (a) and (c) of sub-section (1) of Section 13, clause (a) of sub-section (2) of Section 13, sub-section (3) of Section 22, clause (a) and (c) of Section 27, Section 28, Section 28A, Section 28B and subsection (1) and (2) of Section 30 and other offences relating to adulterated drugs or spurious drugs, shall be released on bail or on his own bond unless-

(i) the Public Prosecutor has been given an opportunity to oppose the application for such release; and

(ii) where the Public Prosecutor opposes the application, the court is satisfied that there are reasonable grounds for believing that he is not guilty of such offence and that he is not likely to commit any offence while on bail:

Provided that a person, who, is under the age of sixteen years,or is a woman or is sick or infirm, may be released on bail, if the Special Court so directs.

(2) The limitation on granting of bail specified in clause (b) of sub-section (1) is in addition to the limitations under the Code of Criminal Procedure, 1973 (2 of 1974) or any other law for the time being in force on granting bail.

(3) Nothing contained in this section shall be deemed to affect the Special powers of the High Court regarding bail under Section 439 of the Code of Criminal Procedure, 1973 (2 of 1974) and the High Court may exercise such powers including the power under clause (b) of sub-section (1) of that section as if the reference to "Magistrate" in that section includes also a reference to "Special Court" designated under Section 36AB.]

3 [36-AD. Application Code of Criminal Procedure, 1973 to proceedings before Special Courts. - (1) Save as otherwise provided in this Act, the provisions of the Code of Criminal Procedure, 1973 (2 of 1974) (including the provisions as to bails and bonds), shall apply to the proceedings before a Special Courts and for the purpose of said provisions, the Special Court shall be deemed to be a Court of Sessions and the person conducting the prosecution before the Special Court, shall be deemed to be a Public Prosecutor:

Provided that the Central Government or the State Government may also appoint, for any case or cases or group of cases, a Special Public Prosecutor.

(2) A person shall not be qualified to be appointed as Public Prosecutor or a Special Public Prosecutor under this section unless he has been in practice as an advocate for not less than seven years, under the Union or a State, requiring special knowledge of law.

(3) Every person appointed as a Public Prosecutor or a Special Public Prosecutor under this section shall be deemed to be a Public Prosecutor within the meaning of clause (u) of 41 Section 2 of the Code of Criminal Procedure, 1973 (2 of 1974) and the provisions of that Code shall have effect accordingly.]

3 [36AE. Appeal and revision.- The High Court may exercise, so far as may be applicable, all the powers conferred by Chapter XXIX or Chapter XXX of the Code of Criminal Procedure, 1973(2 of 1974), on a High Court, as if a Special Court within the local limits of the jurisdiction of the High Court were a Court of Session trying cases within the local limits of the jurisdiction of the High Court.]

37. Protection of action taken in good faith.—No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act.

1 [38. Rules to be laid before Parliament.— Every rule made under this Act shall be laid as soon as may be after it is made before each House of Parliament while it is in session for a total period of thirty days which may be comprised in one session or in two or more successive sessions,²[and if, before the expiry of the session immediately following the session or the successive sessions aforesaid], both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified from or be of no effect, as the case may be; so however that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.]

1. Ins. by Act 13 of 1964, s. 30 (w.e.f. 15-9-1964).

34

Drugs and Cosmetics Act, 1940

1 [THE FIRST SCHEDULE

[See section 3(a)] 2 [A.—AYURVEDIC AND SIDDHA SYSTEMS] Serial No. Name of book

Ayurveda

1. Arogya Kalpadruma

2. Arka Prakasha

3. Arya Bhishak

4. Ashtanga Hridaya

5. Ashtanga Samgraha

6. Ayurveda Kalpadruma

7. Ayurveda Prakasha

8. Ayurveda Samgraha

9. Bhaishajya Ratnavali

10. Brihat Bhaishajya Ratnakara

11. Bhava Prakasha

12. Brihat Nighantu Ratnakara

13. Charaka Samihita

14. Chakra Datta

15. Gada Nigraha

16. Kupi Pakva Rasayana

17. Nighantu Ratnakara

18. Rasa Chandanshu

19. Rasa Raja Sundara

20. Rasaratna Samuchaya 21.³[Rasatantra Sara Va Siddha Prayoga Sangraha—Part 1] 4 [21 (a) Rasatantra Sara Va Siddha Prayoga Sangraha—Part II (Edition 2006)]

22. Rasa Tarangini

23. Rasa Yoga Sagara

24. Rasa Yoga Ratnakara

25. Rasa Yoga Samgraha

26. Rasendra Sara Samgraha

27. Rasa Pradipika

28. Sahasrayoga

29. Sarvaroga Chikitsa Ratnam

30. Sarvayoga Chikitsa Ratnam

31. Sharangadhara Samhita

32. Siddha Bhaishajya Manimala

33. Siddha Yoga Samgraha

34. Sushruta Samhita

35. Vaidya Chintamani

36. Vaidyaka Shabda Sindu

37. Vaidyaka Chikitsa Sara

38. Vidya Jiwan

39. Vasava Rajeeyam

40. Yoga Ratnakara

41. Yoga Tarangini

42. Yoga Chintamani

43. Kashyapasamhita

44. Bhelasamhita

45. Vishwanathachikitsa

46. Vrindachikitsa

1. Subs. by Act 13 of 1964, s. 31, for the Sch. The First Schedule came into force with effect from 1-2-1969 and the Second Schedule came into force with effect from the 15^th September, 1964.

2. Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983).

35

Drugs and Cosmetics Act, 1940 Serial No. Name of book

47. Ayurvedachintamani

48. Abhinavachintamani

49. Ayurveda-Ratnakara

50. Yogaratnasangraha

51. Rasamrita

52. Dravyagunanighantu

53. Rasamanjari

54. Bangasena

1 [54A 6

[Ayurvedic Formulary of India and its Parts) 54B Ayurveda Sara Samgraha]

2 [54C Ayurvedic Pharmacopoeia of India.] 5 [54D. Ayurvedic Pharmacopoeia of India and its Parts.] Siddha

55 Siddha Vaidya Thirattu

56 Therayar Maha Karisal

57 Brahma Muni Karukkadai (300)

58 Bhogar (700)

59 Pulippani (500)

60 Agasthiyar Paripuranam (400)

61 Therayar Yamagam

62 Agasthiyar Chenduram (300)

63 Agasthiyar (1500)

64 Athmarakshamrutham

65 Agasthiyar Pin (80)

66 Agasthiyar Rathna Churukkam

67 Therayar Karisal (300)

68 Veeramamuni Nasa Kandam

69 Agasthiyar (600)

70 Agasthiyar Kanma Soothiram 71 18 Siddar's Chillarai Kovai

72 Yog Vatha Kaviyam

73 Therayar Tharu

74 Agasthiyar Vaidya Kaviyam (1500)

75 Bala Vagadam

76 Chimittu Rathna (Rathna) Churukkam

77 Nagamuni (200)

78 Agasthiyar Chillarai Kovai

79 Chikicha Rathna Deepam

80 Agasthiyar Nayana Vidhi

81 Yugi Karisal (151)

82 Agasthiyar Vallathi (600)

83 Therayar Thaila Varkam 31 [84 Siddha Formulary of India (Part I)] 5 [85 Siddha Formulary of India and its Parts] 4 [B.—UNANI TIBB SYSTEM]

Serial No. Name of book

1 Karabadin Qadri

2 Karabadin Kabir

3 Karabadin Azam

4 Ilaj-ul-Amraz

5 Al Karabadin

6 Biaz Kabir Vol. II

7 Karabadin Jadid

8 Kitab-ul-Taklis

9 Sanat-ul-Taklis

10 Mifta-ul-Khazain

11 Madan-ul-Aksir

12 Makhzan-ul-murabhat 1 [13 National Formulary of Unani Medicine 7 [****]] 8 [14 Unani Pharmacopoeia of India]

1. Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987. 6. Subs. by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010).

2. Ins. by Notifn. No. G.S.R. 423 (E), dated the 11th June, 2002. 7. Omitted by GSR 780(E), dt 25-11-2004.

3. Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987. 8. Ins by GSR 780 (E), dt. 25.11.20114.

4. Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983).

5. Ins. by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010).

36

Drugs and Cosmetics Act, 1940

4 [THE SECOND SCHEDULE

(See sections 8 and 16)

STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, SOLD,

STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED

Class of drug Standard to be complied with

1 2

1. Patent or proprietary medicines¹[other than The formula of list of ingredients displayed in the Homoeopathic medicines] prescribed manner on the label of the container and such other standards as may be prescribed.

2.²[Substances commonly known as vaccines, sera The standards maintained at the International toxins, toxoids, antitoxins and antigens and Laboratory for Biological Standards, Stantans Serum biological products of like nature, for human use or Institute, Copenhagen and at the Central Veterinary for veterinary use. Laboratory, Weybridge Surrey, U.K., and such other

laboratories recognized by the World Health

Organization from time to time, and such further

standards of strength, quality and purity, as may be

prescribed.]

3[* * * *]

4. Substances (other than food) intended to affect the Such standards as may be prescribed. structure or any function of the human body or

intended to be used for the destruction of vermin or

insects which cause disease in human beings or

animals.

5 [ 1 [4-A. Homoeopathic Medicines.

(a) Drugs included in the Homoeopathic Standards of identity, purity and strength specified in Pharmacopoeia of India. the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as

may be prescribed.

(b) Drugs not included in the Homoeopathic Standards of identity, purity and strength prescribed Pharmacopoeia of India but which are

for the drugs in the edition of such Pharmacopoeia included in the Homoeopathic

for the time being in which they are given and such Pharmacopoeia of United States of

other standards as may be prescribed. America or the United kingdom or the

German Homoeopathic Pharmacopoeia.

(c) Drugs not included in the Homoeopathic The formula or list of ingredients displayed in the Pharmacopoeia of India or the United prescribed manner on the label of the containder and States of America, or the United such other standards as may be prescribed by the Kingdom or the German Homoeopathic Central Government].]

Pharmacopoeia.

37

Drugs and Cosmetics Act, 1940 Class of drug Standard to be complied with

1 2

1 [5. Other drugs:

(a) Drugs included in the Indian Pharmacopoeia Standards of identity, purity and strength specified in the edition of the Indian Pharmacopoeia for the

time being in force and such other standards as may

be prescribed.

In case the standards of identity, purity and strength

for drugs are not specified in the edition of the

Indian Pharmacopoeia for the time being in force

but are specified in the edition of the Indian

pharmacopoeia immediately preceding, the

standards of identity, purity and strength shall be

those occurring in such immediately preceding

edition of the Indian Pharmacopoeia and such other

standards as may be prescribed.

(b) Drugs not included in the Indian Standards of identity, purity and strength specified Pharmacopoeia but which are included in the for drugs in the edition of such official official Pharmacopoeia of any other country. Pharmacopoeia of any other country for the time being in force and such other standards as may be

prescribed.

In case the standards of identity, purity and strength

for drugs are not specified in the edition of such

official Pharmacopoeia for the time being in force,

but are specified in the edition immediately

preceding, the standards of identity, purity and

strength shall be those occurring in such

immediately preceding of such official

Pharmacopoeia and such other standards as may be

prescribed.]]

1. Subs. by Notifn. No. G.S.R. 885, dated the 4^th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643, for item 5.

38

Drugs and Cosmetics Rules, 1945 [21st December 1945]

Notificaiton: No. F. 28-10/45-H (1).^_In exercise of the powers conferred by¹[sections 6(2), 12, 33 and 33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central Government is pleased to make the following Rules:-

PART I

PRELIMINARY

1. Short title, extent and commencement. (1) These Rules may be called the Drugs⁹[and Cosmetics] Rules, 1945.

(2) They extend to the whole of India. 2 [***]

10

[***]

2. Definitions. In these Rules, unless there is anything repugnant in the subject or context

(a) "the Act" means the Drugs and Cosmetics Act, 1940 (XXIII of 1940) as amended from time to time;

3 [(b) "Central Licence Approving Authority" means the Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government;]

(c) "Director" means the Director of the Central Drugs Laboratory;

(d) "Form" means a form set forth in Schedule A; 4 [(dd) Homoeopathic medicines include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route;]

(e) "Laboratory" means the Central Drugs Laboratory; 5 [(ea) "registered Homoeopathic medical practitioner" means a person who is registered in the Central Register or State Register of Homoeopathy;]

8

[(eb)"Phytopharmaceutical drug" includes purified and standardised fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route.]

6 [(ee) "Registered medical practitioner" means a person

(i) holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or

(ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine⁷[excluding the Homoeopathic system of medicine]; or

1. Subs. by G.S.R. 370(E), dt. 7-4-1994. 2. Omitted by G.S.R. 358, dt. 15-3-1975.

3. Sub. by GSR. 579(E), dt. 20-9-2006, earlier Ins. by G.S.R. 923(E), dt. 14-12-1992.

4. Ins. by Notfn. No. F. 1-59 / 68-D, dt. 19-11-1969.

5. Ins. by G.S.R 680 (E), dt. 5-12-1980. 6. Ins. by Notfn. F. 1-22 / 59-D, dt. 9-4-1960.

7 . Ins. by S.O. 2139, dt. 15-6-197 2. 8. Ins. By G.S.R 918(E), dt. 30-11-2015.

9. Ins. by GSR 1183(E), dt 17-8-1964. 10. Sub-rule (3) omitted by GSR 19, dt. 15-12-1977.

39

Drugs and Cosmetics Rules 1945

(iii) registered in a medical register,¹[other than a register for the registration of Homoeopathic practitioner], of a State, who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practising the modern scientific system of medicine for the purposes of this Act; or

(iv) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or

(v) who is engaged in the practice of veterinary medicine and who possesses qualifications approved by the State Government;] 2 [(f) "retail sale" means a sale 3 [whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person] other than a sale by way of wholesale dealing];

4

[(g) "sale by way of wholesale dealing" means sale to a person for the purpose of selling again and includes sale to a hospital, dispensary, medical, educational or research institution;]

5 [(h) "Schedule" means a Schedule to these Rules;]

6 [(i) State Government in relation to a Union Territory means the Administrator thereof;

9 [***]

PART II

THE CENTRAL DRUGS LABORATORY

3. Functions. It shall be the function of the Laboratory

(i) to analyse or test such samples of drugs as may be sent to it under sub- section (2) of section 11, or under sub-section (4) of section 25 of the Act; 7 [* * * * *]

(iii) to carry out such other duties as may be entrusted to it by the Central Government or, with the permission of the Central Government, by a State Government after consultation with the Drugs Technical Advisory Board. 8 [3A. (1)The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute :

(1) Sera.

(2) Solution of serum proteins intended for injection.

(3) Vaccines.

(4) Toxins.

(5) Antigens.

40

Drugs and Cosmetics Rules 1945

(6) Anti-toxins.

(7) Sterilized surgical ligature and sterilised surgical suture.

(8) Bacteriophages:

1 [Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central Research Institute, Kasauli only.] 2 [(1A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes and the functions of the Director in respect of the said drugs shall be exercised by the Director of the respective Institutes :-

(a) Pasteur Institute of India, Coonoor.

(b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute Compound, Parel, Bombay-400012.] 3 [(c) The National Institute of Biologicals, NOIDA.] 4 [(2) The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes.

(1) Anti-sera for veterinary use.

(2) Vaccines for veterinary use.

(3) Toxoids for veterinary use.

(4) Diagnostic Antigens for veterinary use.] 5 [(3) The functions of the laboratory in respect of testing of condoms shall be carried out at the Central Drugs Testing Laboratory, Chennai, and the functions of the Director in respect of the said products shall be exercised by the Director of the said Laboratory.]

6 [(4)] The functions of the Laboratory in respect of the following drug shall be carried out at the Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta and the functions of the Director in respect of the said drug shall be performed by the Serologist and Chemical Examiner of the said Laboratory :

VDRL Antigen.

⁷[(5) The function of the Laboratory in respect of Intra-Utrine Devices and Falope Rings shall be carried out at the Central Drugs Testing Laboratory, Thane, Maharashtra and the functions of the Director in respect of the said devices shall be exercised by the Director of the said Laboratory.]

1. Subs. by G.S.R.445(E), dt. 30-4-1992. Earlier Ins. by G.S.R.62(E), dt. 15-2-1982.

2. Ins. by G.S.R. 445(E), dt. 30-4-1992.

3. Ins. by G.S.R.249(E), dt. 4-4-2002.

4. Ins. by Notfn. No. F.-1-6/62-D, dt. 2-7-1969.

5. Sub. By G.S.R. 651(E), dt. 9-9-2009, earlier Ins. by S. O. No. 2139, dt. 12-8-1972.

6. Sub-rule (4) omitted and sub-rule (5) renumbered as sub-rule (4) by Notfn. No. G.S.R. 62(E), dt. 15-2-1982.

41

Drugs and Cosmetics Rules 1945 1 [(6) The functions of the Laboratory in respect of human blood and human blood products including components, to test for freedom of HIV antibodies, shall be carried out by the following Institutes/Hospitals and the functions of the Director in respect of the above mentioned products shall be exercised by the head of the respective Institute, namely:-

(a) National Institute for Communicable Disease, Department of Microbiology, Delhi.

(b) National Institute of Virology, Pune

(c) Centre of Advanced Research in Virology, Christian Medical College, Vellore.]

2 [(7) The functions of the Laboratory in respect of Homoeopathic medicines shall be carried out at the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.]

3

[(8) (a) The functions of the Laboratory in respect of the following kits or class of drugs shall be carried out at the National Institute of Biologicals, Noida and the functions of the Director in respect of the said drugs or class of drugs shall be exercised by the Director of the said institute.

(b) The kits or class of drugs referred to in clause (a) are-

(1) Blood grouping reagents.

(2) Diagnostic kits for human immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus.

(3) Blood products-

(a) Human Albumin;

(b) Human Normal Immunoglobulin (intramuscular and intravenous);

(c) Human Coagulation Factor VIII;

(d) Human Coagulation Factor IX;

(e) Plasma Protein Fractionation;

(f) Fibrin Sealant Kit;

(g) Anti Inhibitor Coagulation complex.

(4) Recombinant products such as-

(a) Recombinant insulin and insulin analogue;

(b) r-erythropoietin (EPO);

(c) r-Granulocyte Colony stimulating Factor (G-CSF).

(5) Biochemical kits-

(a) Glucose Test Strips;

(b) Fully Automated analyzer based glucose reagents.]

4. Despatch of samples for test or analysis.- (1) Samples for test or analysis under sub-section (4) of section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director.

(2) The packet as well as the outer cover, shall be marked with a distinguishing number.

(3) A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director.

5. Recording of condition of seals. On receipt of the packet, it shall be opened by an officer authorised in writing in that behalf by the Director who shall record the condition of the seal on the packet.

1. Ins. by G.S.R 16(E), dt. 10-1-1990. 2. Ins. by G.S.R 246(E), dt. 1-5-1991.

3. Sub. by G.S.R. No. 908(E), dt. 4-4-2014. Earlier Ins. by G.S.R. No. 249 (E), dt. 4-4-2002.

42

Drugs and Cosmetics Rules 1945

6. Report of result of test or analysis. After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.

7. Fees. The fees for test and analysis shall be those specified in Schedule B.

8. Signature of certificates. Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorised by the Central Government by Notification in the Official Gazette to sign such certificates.

1 [PART III

[RULES 9 to 20- omitted by SRO. 2136 dated 15-06-1957]

PART IV

2 [IMPORT AND REGISTRATION]

21. In this Part.- 3 [(a) "import licence" means either a licence in Form 10 to import drugs 4 [* * *]; excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X;]

(b) "licensing authority" means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22;

(c) "licence for examination, test or analysis" means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis;

5 [(d) "manufacturer" includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and /or in other major countries;

(e) "Registration Certificate" means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.]

22. The licensing authority may with the approval of the Central Government by an order in writing delegate the²[power to sign licences and Registration Certificate and] such other powers as may be specified in the order to any other person under his control.

1. Part III (Rules 9 to 20) omitted by Notfn. No. F. 1-16/57-D (SRO 2136), dt. 15-6-1957.

43

Drugs and Cosmetics Rules 1945 1 [23. Import licences.-An import licence in Form 10 shall be required for 2 [import of drugs], excluding those specified in Schedule X, and an import licence in Form 10- A shall be required for the import of drugs specified in Schedule X.] 2 [24. Form and manner of application for import licence.- (1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these Rules, or by the manufacturer's agent in India either having a valid licence under the Rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these Rules, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer:

Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug:

(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27A:

Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10A, as the case may be, without the issuance of Registration Certificate under Rule 27A, for reasons to be recorded in writing.

3 [Provided further that Registration certificate shall not be required to be accompanied with an application for an import licence under the Rules for the import of in-vitro diagnostic kits and regents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3.]

(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this Rule, if the original is defaced, damaged or lost.]

4

[24A. Form and manner of application for Registration Certificate.—(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by the fee specified in sub-rule (3) and the informations and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer.

1. Subs. by G.S.R. 462 (E), dt. 22-6-1982.

2. Subs. by G.S.R 604 (E), dt. 24-8-2001.

3. Ins. by G.S.R. 35(E), dt. 20.1.2005.

4. Ins. by G.S.R 604 (E), dt. 24-08-2001.

44

Drugs and Cosmetics Rules 1945

(2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate.

(3) (i) A fee of one thousand and five hundred US dollars¹[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India

(ii) A fee of one thousand US dollars¹[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug:

Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars¹[or its equivalent in Indian rupees] for each drug.

(4) The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines":

Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account "0210- Medical and Public Health, 04- Public Health, 104-Fee and Fines", and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment.

(5) The applicant shall be liable for the payment of a fee of five thousand US dollars¹[or its equivalent in Indian rupees] for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under Rule 22.

(6) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.

(7) A fee of three hundred US dollars¹[or its equivalent in Indian rupees] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.

(8) No Registration Certificate shall be required under these Rules in respect of an inactive bulk substance to be used for a drug formulation, with or without pharmacopoeial conformity.]

1 . Ins. by G.S.R. 35(E), dt. 20.1 .2005.

45

Drugs and Cosmetics Rules 1945

25. Licences for import of drugs manufactured by one manufacturer.- (1) A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer:

1 [Provided that the drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:

Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of the drugs manufactured by each such factory.]

2

[* * * * *] 3 [25A. Condition to be satisfied before a licence in Form 10 or Form 10-A is granted. (1) A licence in Form 10 or in Form 10-A shall be granted by the licensing authority having regard to-

(i) the premises, where the imported substances will be stocked, are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and

(ii) the occupation, trade or business ordinarily carried out by the applicant:

Provided that the licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,--

(a) that the applicant has not complied with the provisions of the Act or these rules; or

(b) that by reasons of— 4 [(i) his conviction under the Act or these Rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) or the rules made thereunder;]

(ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted.

(2) Any person who is aggrieved by the order passed by the licensing authority under this Rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit.]

1. Ins. by Notfn. No. F. 1-19/48-D, dt. 27-10-1949.

2. Omitted Notfn. No.F. 1-16/57-D, dt. 15-6-1957.

3. Subs. by G.S.R 462(E), dt. 22-6-1982. Earlier Ins. by Notfn. No. F. 1-9/52-D. dt. 3-11-1958.

4. Subs. by G.S.R 604 (E), dt. 24-8-2001.

46

Drugs and Cosmetics Rules 1945 1 [25B. Registration Certificate for import of drugs manufactured by one manufacturer.--(1) A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer:

Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:

Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.]

26. Conditions of import licence. An import licence shall be subject to the following conditions:

(i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9;

(ii) the licensee shall allow any Inspector authorised by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples;

(iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied;

(iv) if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate authorising the sale of the batch has been issued to him by or on behalf of the licensing authority;

(v) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall the issues already made from that batch;

(vi) the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorised in that behalf by the licensing authority:

1. Ins. by G.S.R. No. 604(E), dt. 24-8-2001.

47

Drugs and Cosmetics Rules 1945 1 [Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely:

1. Name of the Drug,

2. Batch number,

3. Name and address of the manufacturer,

4. Date of transaction,

5. Opening stock on the business day,

6. Quantity of drug received, if any, and the source from which received,

7. Name of the purchaser, his address and licence number,

8. Balance quantity of drug at the end of the business day,

9. Signature of the person under whose supervision the drugs have been supplied.]

(vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months' notice.

27. Grant of import licence. On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10¹[or From 10A, as the case may be]. 2 [27A Grant of Registration Certificate. (1) On receipt of an application for Registration Certificate in the Form and manner specified in Rule 24A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41:

Provided further that if the application is complete in all respects and informations specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit.

(2) If the applicant does not receive the Registration Certificate within the period as specified in the proviso to sub-rule (1), he may appeal to the Central Government and the Central Government may after such enquiry into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.]

48

Drugs and Cosmetics Rules 1945 1 [28. Duration of import licence. A licence unless, it is sooner suspended or cancelled, shall be²[valid for a period of three years from the date of its issue:] Provided that if application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.]

3 [28A. Duration of Registration Certificate.—- A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue:

Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.]

4 [29. Suspension and cancellation of import licence. If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit, either wholly or in respect of some of the substances to which it relates:

Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.]

3 [29A. Suspension and cancellation of Registration Certificate. —If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:

Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.]

1. Amended by Notfn. No. F. 1-10/62-D, dt. 19-4-1964.

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Drugs and Cosmetics Rules 1945

30. Prohibition of import after expiry of potency. —No biological or other special product specified in Schedule C or C (I) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test. 1 [* * * * *]

2 [30AA. Import of new Homoeopathic medicine.—(1) No new Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.

(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.] 3 [Explanation. —For the purpose of this rule, 'New Homoeopathic Medicine' means—

(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or

(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or

(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended.] 4 [30B. Prohibition of import of certain drugs. No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.]

5 [31. Standard for certain imported drugs.—No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the Rules shall be applicable for determining whether any such imported drug complies with the said standard:

Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:

1. Rule 30A omitted by G.S.R.944 (E), dt. 21-9-1988. Earlier rules 30A and 30AA ins. by Notfn. F. 1- 30/48-G, Dt. 14.4.1952.

2. Ins. by notification No. F 1-30/48, dt. 14-01-1952.

3. Subs. G.S.R. 680 (E) ,dt. 5-12-1980.

4. Ins. by Notfn. No. F. 1-45 4-1-1951.

5. Subs. G.S.R. 604 (E), dt. 24-8-2001.

50

Drugs and Cosmetics Rules 1945 Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent residual shelf-life period as on the date of import:

Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow, the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.] 1 [32. Packing and labelling of imported drugs. No drug shall be imported unless it is packed and labelled in conformity with the Rules in Parts IX and X²[* * *] and further conform to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform to the rules in Parts IX and X and Schedule F(1)].

3 [32A Packing and Labelling of Homoeopathic medicine. No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.]

33. Import of drugs for examination, test or analysis Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:

(a) No drug shall be imported for such purpose except under a licence in Form 11;

(b) the licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorise;

(c) the licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof;

(d) the licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer;

(e) the licensee shall comply with such further requirements, if any, applicable to the holders of licences for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice.

1. Subs. by Notfn. No. F. 1-6/62-D (SO 2889), dt. 2-7-1969.

51

Drugs and Cosmetics Rules 1945 1 [33A Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.—Small quantities of new drug, as defined in Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:-

(a) no new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin;

(b) the licensee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorise;

(c) the licensee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof ;

(d) the licensee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease;

(e) the licensee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice;

(f) the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist;

(g) the quantity of any single drug so imported shall not exceed 100 average dosages per patient:

Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug of a larger quantity.]

34. Application for licence for examination, test or analysis. (1) An application for a licence for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted.

1. Ins. by G.S.R 604 (E), dt. 24-8-2001.

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Drugs and Cosmetics Rules 1945

(2) The licensing authority may require such further particulars to be supplied as he may consider necessary.

1 [(3) Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.

(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210-Medical and Public Health, 04- Public Health, 104- Fees and Fines.]

2 [34A. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients. (1) An application for an import licence for small quantities of a new drug, as defined in Rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be.

(2) The licensing authority may require such further particulars to be supplied, as he may consider necessary.

(3) Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.

(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210- Medical and Public Health, 04- Public Health, 104- Fees and Fine.]

35. Cancellation of licence for examination, test or analysis. (1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued.

(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months of the date of the order.

1. Subs. by G.S.R 604 (E), dt. 24-8-2001.

2. Ins. by G.S.R 604 (E), dt. 24-8-2001.

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Drugs and Cosmetics Rules 1945

1

[35A. Cancellation of licence for import of small quantities of new drugs. (1) A licence for import of small quantities of a new drug, defined in Rule122E, for the purpose of the treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder.

(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit.]

36. Import of drugs for personal use. Small quantities of drugs, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:

(i) the drugs shall form part of a passenger's bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;

(ii) the drugs shall be declared to the Customs authorities if they so direct;

(iii) the quantity of any single drug so imported shall not exceed one hundred average doses :

Provided that the licensing authority may in an exceptional case in any individual case sanction the import of a larger quantity:

2

[Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:

(i) the licensing authority, on an application made to it in Form 12A is satisfied that the drug is for bona fide personal use;

(ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and

(iii) the licensing authority grants a permit in respect of the said drug in Form

12B.]

3

[37. Packing of patent or proprietary medicine. —Patent or proprietary medicines shall be imported in containers intended for retail sale:

4

[Provided that such medicines may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission].]

38. Statement to accompany imported drugs. All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the name and quantities of the drugs.

39. Documents to be supplied to the Customs Collector. Before drugs for the import of which a licence is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall be supplied to the Customs Collector.

1. Ins. by G.S.R 604 (E), dt. 24-8-2001.

2. Ins. by Notfn. No.F-1-36/54-D.S., (SRO 560), dt. 3-3-1955.

3. Ins. by Notfn. No.F-1-3/51-D.S., (SRO 3262), dt. 15-10-1954.

4. Ins. by Notfn. No.F-1-45/58-D, (SO 115), dt. 4-1-1961.

54

Drugs and Cosmetics Rules 1945 1 [ 40. Procedure for the import of drugs. (1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions of Chapter III of the Act and Rules thereunder he may, and if requested by an officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the Director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the Director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government, on such samples is received:

Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall make over the consignment to the importer.

(2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required by the Customs Collector to return the consignment or any portion thereof he shall return the consignment or portion thereof within ten days of receipt of the notice.]

2 [41. (1) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government, reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall cause them to be destroyed :

Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs Collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final.

3 [(2) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorised in this behalf by the Central Government.]]

4 [* * * * *]

1. Subs. by Notifn. 1-99/52-D.S., dated 3-11-1953.

2. Subs. by Notfn. No. F. 7-7/47-D, dt. 5-1-1954.

3. Ins. by Notfn. No. 7-11/47-D, dt. 5-10-1951.

4. Rule 42 omitted by Notfn. No. F. 1-9/52-DS., dt. 3-11-1953.

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Drugs and Cosmetics Rules 1945

43. The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule.

1 [43A. No drug shall be imported into India except through one of the following places, namely:

Freozepore Cantonment and Amritsar Railway Stations:

In respect of drugs imported by rail across the frontier with Pakistan. Ranaghat, Bongaon and Mohiassan Railways Stations:

In respect of drugs imported by rail across the frontier with Bangladesh. 5 [Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in Tripura :

In respect of drugs imported by Road from Bangladesh;]

2 [Raxaul:

In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal;]

4 [Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla and Inland Container Depots at Tuglakabad and Patparganj in Delhi and Tuticorin in Tamil Nadu and Marmugao port in Goa and Visakhapatnam in Andhra Pradesh:

In respect of drugs imported by sea into India;

Chennai, Kolkata, Mumbai, Delhi,Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam:

in respect of drugs imported by air into India.]

4 [43-B. Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Rules made thereunder:

Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences.]

1. Subs. by G.S.R 478 (E), dt. 6-8-1981. Earlier Ins. by Notfn No. F.7/7/47-D. dt. 5-1-1954.

2. Ins. by G.S.R 120 (E), dt. 5-3-1998.

3. Sub. by G.S.R 532 (E), dt. 18-05-2016. Earlier sub. by G.S.R 575 (E), dt. 17-11-2012, G.S.R 101 (E), dt. 18-2-2011, G.S.R 45 (E), dt. 21-1-2010, G.S.R 504 (E), dt. 18-7-2002, G.S.R 647 (E), dt. 28-10-1998.

4. Added by Notfn. No. E. 1-60/D, (SO 1056) dt. 19-3-1964.

5. Ins. by G.S.R. 116 (E), 24-01-2009.

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Drugs and Cosmetics Rules 1945

PART V

1 [GOVERNMENT ANALYSTS, INSPECTORS, LICENSING

AUTHORITIES AND CONTROLLING AUTHORITIES]

2 [44. Qualifications of Government Analyst. A person appointed as a Government Analyst under the Act shall be a person who

(a) is a graduate in medicine or science or pharmacy or Pharmaceutical Chemistry of a³[University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had not less than five years' post-graduate experience in the testing of drugs in a laboratory under control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority,⁴[or has completed two years' training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory], or

(b) possesses a post-graduate degree in medicine or science or pharmacy or Pharmaceutical chemistry of a³[University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] or possesses the Associateship Diploma of the Institution of Chemists (India) obtained by passing the said examination with 'Analysis of Drugs and Pharmaceuticals' as one of the subjects and has had after obtaining the said post-graduate degree or diploma not less than three years' experience in the testing of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority⁴[or has completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory]:

Provided that-

4 [(i) for purpose of examination of items in Schedule C,- (ia) the persons appointed under clause (a) or (b) and having degree in Medicine, Physiology, Pharmacology, Microbiology, Pharmacy should have experience or training in testing of said items in an institution or laboratory approved by the appointing authority for a period of not less than six months;

(ib) the person appointed under clause(a) or (b) but not having degree in the above subjects should have experience or training in testing of said Schedule C drugs for a period of not less than three years in an institution or laboratory approved by the appointing authority or have completed two years training on testing of drugs including items stated in Schedule C in Central Drugs Laboratory;]

1. Subs. by G.S.R 443 (E), dt. 12-4-1989.

2. Subs. by G.S.R. No. 1427, dt. 22-10-1977.

3 . Subs. by G.S.R. 71(E), dt 3 0.1.1987.

4 . Ins. by G.S.R 697(E) dt. 26-10-1995.

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Drugs and Cosmetics Rules 1945

(ii) for a period of four years from the date on which Chapter IV of the Act takes effect in the States, persons whose training and experience are regarded by the appointing authority as affording, subject to such further training, if any, as may be considered necessary, a reasonable guarantee of adequate knowledge and competence, may be appointed as Government Analysts. The persons so appointed may, if the appointing authority so desires, continue in service after the expiry of the said period of four years;

(iii) no person who is engaged directly or indirectly in any trade or business connected with the manufacture of drugs shall be appointed as a Government Analyst for any area:

Provided further that for the purpose of examination of Anti-sera, Toxoid and Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a person who is a graduate in Veterinary Science, or general science, or medicine or pharmacy and has had not less than five years' experience in the standardization of biological products or person holding a post-graduate degree in Veterinary Science, or general science, or medicine or pharmacy or pharmaceutical chemistry with an experience of not less than three years in the standardization of biological products :

Provided also that persons, already appointed as Government Analysts may continue to remain in service, if the appointing authority so desires, notwithstanding the fact that they do not fulfil the qualifications as laid down in clause (a), clause (b) or the preceding proviso.

45. Duties of Government Analysts.−(1) The Government Analyst shall cause to be analysed or tested such samples or drugs¹[and cosmetics] as may be sent to him by Inspectors or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these Rules.

(2) A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government.

46. Procedure on receipt of sample.−On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet²[or on portion of sample or container] with the specimen impression received separately and shall note the condition of the seals on the 3 [packet or on portion of sample or container]. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied:

58

Drugs and Cosmetics Rules 1945 1 [Explanation. It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of "protocols of the tests or analysis applied", if

(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;

(2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;

(3 )for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report;

(4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report;

(5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report.]

47. Report of result of test or analysis. An application from a purchaser for test or analysis of a drug under section 26 of the Act shall be made in Form 14 A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14B.

48. Fees. The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a drug³[or cosmetic] purchased by him shall be those specified in Schedule B. 2 [49. Qualifications of Inspectors. —A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law:

Provided that only those Inspectors: ⎯

1. Ins. by No. F. 1-60/61-D, dt. 12-7-1962 (G.S.R 984 (E), dt. 12-7-1962).

2. Subs. by No. G.S.R 658 (E), dt. 19-10-1993.

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Drugs and Cosmetics Rules 1945

(i) Who have not less than 18 months' experience in the manufacture of at least one of the substances specified in Schedule C, or

(ii) Who have not less than 18 months' experience in testing of at least one of the substances in Schedule C in a laboratory approved for this purpose by the licensing authority, or

(iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors; shall be authorised to inspect the manufacture of the substances mentioned in Schedule

C:]

1 [Provided further that the requirement as to the academic qualification shall not apply to persons appointed as Inspectors on or before the 18th day of October, 1993.] 2 [ 49A. Qualification of a Licensing Authority.—No person shall be qualified to be a Licensing Authority under the Act unless:-

(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and

(ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:

3 [ Provided that the requirements as to the academic qualification shall not apply to those inspectors and the Government Analysts who were holding those positions on the 12^th day of April,1989.]]

4 [50. Controlling authority. (1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central Government.

(2) All Inspectors appointed by the State Government shall be under the control of an officer appointed in this behalf by the State Government.

(3) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2), shall be a controlling authority.]

1. Ins. by G.S.R 552 (E), dt. 4-12-1996.

2. Ins. by G.S.R 443 (E), dt. 12-4-1989.

3. Subs. by G.S.R. 532 (E), dt. 14.8.1991.

4. Subs. by S.O. 2139, dt. 5-6-1972.

60

Drugs and Cosmetics Rules 1945 1 [50A. Qualification of a Controlling Authority. (1) No person shall be qualified to be a Controlling Authority under the Act unless

(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law; and

(ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:

2 [Provided that the requirements as to the academic qualifications shall not apply to those Inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989.]

51. Duties of Inspectors of premises licensed for sale. Subject to the instructions of the controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for the sale of drugs

(1) to inspect³[not less than once a year] all establishments licensed for the sale of drugs within the area assigned to him;

(2) to satisfy himself that the conditions of the licences are being observed;

(3) to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules thereunder;

(4) to investigate any complaint in writing which may be made to him;

(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder;

(6) to maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and the seizure of stocks, and to submit copies of such record to the controlling authority;

(7) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention of the Act;

1. Ins. by G.S.R 443 (E), dt. 12-04-1989.

2. Subs. by G.S.R 532 (E), dt. 14-8-1991.

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Drugs and Cosmetics Rules 1945

(8) when so authorized by the State Government, to detain imported packages which he has reason to suspect contain drugs, the import of which is prohibited.

52. Duties of Inspectors specially authorized to inspect the manufacture of 1 [drugs or cosmetics]. Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs

(1) to inspect²[not less than once a year], all premises licensed for manufacture of¹[drugs or cosmetics] within the area allotted to him to satisfy himself that the conditions of the licence and provisions of the Act and Rules thereunder are being observed;

(2) in the case of establishments licensed to manufacture products specified in Schedules C and C(1) to inspect the plant and the process of manufacture, the means employed for standardizing and testing the²[drugs or cosmetics], the methods and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the product;

(3) to send forthwith to the controlling authority after each inspection a detailed report indicating the conditions of the licence and provisions of the Act and rules thereunder which are being observed and the conditions and provisions, if any, which are not being observed;

(4) to take samples of the¹[drugs or cosmetics] manufactured on the premises and send them for test or analysis in accordance with these Rules;

(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder.

53. Prohibition of disclosure of information. Except for the purposes of official business or when required by a Court of Law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him in the course of his official duties.

54. Form of order not to dispose of stock. An order in writing by an Inspector under clause (c) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form 15.

1 . Subs. by G.S.R 504 (E), dt. 1 8-7-2002.

2. Subs. by G.S.R 700 (E), dt. 28-9-2001.

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Drugs and Cosmetics Rules 1945 1 [54A. Prohibition of sale. No person in possession of a drug 2 [or cosmetic] in respect of which an Inspector has made an order under clause (c) of sub-section (1) of section 22 of the Act shall in contravention of that order sell or otherwise dispose of any stock of such drug²[or cosmetic].

3 [55. Forms of receipts for seized drug, cosmetic, record register, document or any other material object.-- A receipt by an Inspector for the stock of any drug or cosmetic or for any record, register, document or any other material object seized by him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form 16.]

4 [55A. Manner of certifying copies of seized documents.—The Drugs Inspector shall return the documents , seized by him under clause (cc) or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they have seized or, as the case may be, the person who produced them, after copies thereof of extracts therefrom have been signed by the concerned Drug Inspector and the person from whom they have seized , or, as the case may be , who produced such records.]

56. Form of intimation of purpose of taking samples. When an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.

5 [56A. Form or receipt for samples of drugs where fair price tendered is refused.—Where the fair price, for the samples of drugs taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17A.]

57. Procedure for despatch of sample to Government Analyst. (1) The portion of sample or the container sent by an Inspector to the Government Analyst for test or analysis under sub-section (4) of section 23 of the Act shall be sent by registered post or by hand in a sealed packet, enclosed together with a memorandum in Form 18, in an outer cover addressed to the Government Analyst.

(2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the Government Analyst separately by registered post or by hand.

1. Ins. by No. F. 1-19/59-D, dt. 13-6-1961.

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Drugs and Cosmetics Rules 1945 1 [58. Confiscation of drugs, implements, machinery etc. (1) Where any person has been convicted for contravening any of the provisions of Chapter IV of the Act or any Rule made thereunder, the stock of the drug in respect of which the contravention has been made shall be liable to confiscation.

(2) Where any person has been convicted for the manufacture of any drug deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) or clause (g) of section 17 of the Act, or adulterated drug under section 17B of the Act, or for manufacture for sale, or stocking or exhibiting for sale or distribution of any drug without a valid licence as required under clause (c) of section 18 of the Act, any implements or machinery used in such manufacture, sale or distribution and any receptacle, packages, or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation.]

2 [58A. Procedure for disposal of confiscated drugs. (1) The Court shall refer the confiscated drugs to the Inspector concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the Rules in any respect.

(2) If the Inspector, on the basis of Government Analyst's report finds the confiscated drugs to be not of standard quality or to contravene any of the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. The Court shall thereupon order the destruction of the drugs. The destruction shall take place under the supervision of the Inspector in the presence of such authority, if any, as may be specified by the Court.

(3) If the Inspector finds that the confiscated drugs are of standard quality and do not contravene the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly.³[The Court may then order the Inspector to give the stocks of confiscated drugs to hospital or dispensary maintained or supported by the Government or by Charitable Institutions].]

1. Subs. by S. O. 289, dt. 3-2-1973.

2. Ins. by No. F. 1-9/62-D (GSR 6), dt. 2-12-1964.

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PART VI

SALE OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES

59. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.

1 [(2) Applications for the grant or renewal of a licence 2 [to sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X,³[shall be made in Form 19 accompanied by a fee of rupees one thousand and five hundred or Form 19A accompanied by a fee of rupees five hundred, as the case may be, or in the case of drugs included in Schedule X shall be made in Form 19C accompanied by a fee of rupees five hundred, to the licensing authority:]

Provided that in the case of an itinerant vendor or an applicant who desires to establish a shop in a village or town having population of 5,000 or less, the application in Form 19-A shall be accompanied by a fee of rupees ten .

(3) ³[A fee of rupees one hundred and fifty] shall be paid for a duplicate copy of a licence²[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X, or for a licence²[to sell, stock, exhibit or offer for sale or distribute] drugs, included in Schedule X, if the original is defaced, damaged or lost:

Provided that in the case of itinerant vendor or an applicant who desires to establish a shop in a village or town having a population of 5,000 or less, the fee for a duplicate copy of a licence if the original is defaced, damaged or lost, shall be rupees two.

(4) Application for renewal of a licence²[to sell, stock, exhibit or offer for sale or distribute] drugs, after its expiry but within six months of such expiry³[shall be accompanied by a fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees five hundred per month or part thereof in Form 19, rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19-A and rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19C:] Provided that in the case of an itinerant vendor or an applicant desiring to open a shop in a village or town having a population of 5,000 or less the application for such renewal shall be accompanied by a fee of rupees ten, plus an additional fee at the rate of rupees eight per month or part thereof.]

1. Subs. by G.S.R 462 (E), dt. 22-6-1982.

2 . Subs. by G.S.R 788 (E), dt. 10-10-1985.

3 . Subs. by G.S.R 601 (E), dt. 24-08-2001.

65

Drugs and Cosmetics Rules 1945 1 [60. A licensing authority may with the approval of the State Government by an order in writing delegate the power to sign licences and such other powers as may be specified in the order to any other person under his control.] 2 [61. Forms of licences to sell drugs. (1) a licence 3 [ to sell, stock, exhibit or offer for sale or distribute] drugs other than those specified in Schedules C, C (1) and X and by retail on restricted licence or by wholesale, shall be issued in Form 20, Form 20A or Form 20B, as the case may be:

Provided that a licence in Form 20A shall be valid for only such drugs as are specified in the licence.

(2) A licence³[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted licence or by wholesale shall be issued in Form 21, Form 21A or Form 21B, as the case may be:

4 [Provided that a licence in Form 21A shall not be granted for drugs specified in Schedules C and shall be valid for only such Schedule C (1) drugs as are specified in the licence.]

(3 )A licence³[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedule X by retail or by wholesale shall be issued in Form 20F or Form 20G as the case may be.]

62. Sale at more than one place. If drugs are sold or stocked for sale at more than one place, separate application shall be made, and a separate licence shall be issued, in respect of each such place:

5 [Provided that this shall not apply to itinerant vendors who have no specified place of business and who will be licensed to conduct business in a particular area within the jurisdiction of the licensing authority.]

1. Amended by F. 1-16/57-D, dt. 15-6-1957.

2. Subs. by G.S.R 462 (E), dt. 22-6-1982.

3 . Subs. by G.S.R 788 (E), dt. 10-10-1985.

4. Subs. by G.S.R 487 (E), dt. 2-7-1984.

5. Added by Notfn. No. F. 10-21/49-D, dt. 10-3-1953.

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Drugs and Cosmetics Rules 1945 1 [62A. Restricted licences in Forms 20A and 21A. (a) Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of the Licensing Authority, to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person.

(b) Licences to itinerant vendors shall be issued only in exceptional circumstances for bona fide travelling agents of firms dealing in drugs or for a vendor who purchases drugs from a licensed dealer for distribution in sparsely populated rural areas where other channels of distribution of drugs are not available.

(c) The licensing authority may issue a licence in Form 21A to a travelling agent of a firm but to no other class of itinerant vendors for the specific purpose of distribution to medical practitioners or dealers, samples of biological and other special products specified in Schedule C:

Provided that travelling agents of licensed manufacturers, agents, of such manufacturers and importers of drugs shall be exempted from taking out licence for the free distribution of samples of medicines among members of the medical profession, hospitals, dispensaries and the medical institution or research institutions. 1 [62-B. Conditions to be satisfied before a licence in Form 20A or Form 21A is granted. (1) A licence in Form 20A or Form 21A shall not be granted to any person, unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are adequate and equipped with proper storage accommodation for preserving the properties of drugs to which the licence applies:

Provided that this condition shall not apply in the case of licence granted to itinerant vendors.

(2) In granting a licence under Rule 62A the authority empowered to grant it shall have regard to:

(i) the number of licences granted in the locality during one year immediately preceding; and

(ii) the occupation, trade or business carried on by such applicant :

1. Ins. by Notfn. No. F. 1-9/60-D, dt. 3-7-1961.

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Drugs and Cosmetics Rules 1945 Provided that the licensing authority may refuse to grant or renew a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these Rules or the previous cancellation or suspension of any licence granted thereunder, he is not a fit person to whom a licence should be granted under this rule.

(3) Any person who is aggrieved by the order passed by the licensing authority in sub-rule (1) may, within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter make such order in relation thereto as it thinks fit.]

1 [62C. Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle. (1) Application for the grant or renewal of a licence to sell by wholesale or to distribute from a motor vehicle shall be made to the Licensing Authority in Form 19AA and shall be accompanied by²[a fee of rupees five hundred]:

Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry , the fee payable for renewal of such licence shall be²[rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof].

(2) A fee of²[rupees one hundred and fifty] shall be paid for a duplicate copy of a licence issued under this rule, if the original is defaced, damaged or lost.] 3 [62D. Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle. A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule and Schedule C(1) in Form 20BB and of drugs specified in Schedule C and Schedule C(1) in Form

2 1BB :

Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drug.] 3 [63. Duration of licence. An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled, shall be²[valid for a period of five years on and from the date on which] it is granted or renewed:

1. Ins. by Notfn. No. 1-9/60-D dt. 3-7-1961.

2 . Subs. by Notfn. No. G.S.R 601 (E), dt. 2 4-8-2 001.

3. Amended by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.

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Drugs and Cosmetics Rules 1945

1

[Provided that if the application for renewal of licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry].]

2 [63A. Certificate of renewal of a sale licence. The certificate of renewal of a sale licence in Forms 20, 20A, 20B,³[20F, 20G], 21, 21A and 21B shall be issued in Form 21C.]

4 [63B. Certificate of renewal of licence. A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in Form 21CC.]

5 [64. Conditions to be satisfied before a licence in Form 8 [20, 20B, 20F,20G, 21 or 21B] is granted . (1)A licence in Form

3 [20, 20B, 20F, 20G, 21 or 21B]

6 [to sell, stock, exhibit or offer for sale or distribute] drugs shall not be granted 7 [or renewed] to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted⁷[or renewed] are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs :

Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted⁷[or renewed] unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with:

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Drugs and Cosmetics Rules 1945

(2) In granting¹[or renewing] a licence under sub-rule (1) the authority empowered to grant it shall have regard

2 [(i) to the average number of licences granted 1 [or renewed] during the period of 3 years immediately preceding, and]

(ii) to the occupation, trade or business ordinarily carried on by such applicant during the period aforesaid:

Provided that the licensing authority may refuse to grant or renew a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these rules, or the previous cancellation or suspension of any licence granted¹[or renewed] thereunder, he is not a fit person to whom a licence should be granted¹[or renewed] under this rule. Every such order shall be communicated to the licensee as soon as possible:

3 [Provided further that in respect of an application for the grant of a licence in Form 20B or Form 21B or both, the licensing authority shall satisfy himself that the premises in respect of which a wholesale licence is to be granted¹[or renewed] are:-

(i) of an area of not less than ten square meters; and] 4 [(ii) in the charge of a competent person, who—

(a) is a Registered Pharmacist, or

(b) has passed the matriculation examination or its equivalent examination from a recognised Board with four years' experience in dealing with sale of drugs, or

(c) holds a degree of a recognised University with one year's experience in dealing with drugs:]

5 [Provided also that,-

(i) in respect of an application for the grant of a licence in Form 20 or Form 21 or both, the licensing authority shall satisfy itself that the premises are of an area] of not less than 10 square meters, and

(ii) in respect of an application for the grant of a licence

(A) In Form 20 or Form 21 or both, and

(B) In Form 20 B or Form 21B or both, the licensing authority shall satisfy itself that the premises are of an area not less than

1 5 square meters:

1 . Ins. by G.S.R 681 (E), dt. 6.6.1 988.

2. Subs. by Notfn. No. F. 1-19/59-D, dt. 13-6-1961.

3. Ins. by G.S.R 681(E), dt. 6.6.1980.

4. Substituted. G.S.R 351(E), dt. 26-4-2000.

5. Ins. by G.S.R 91(E), dt. 25-2-1997.

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Drugs and Cosmetics Rules 1945 Provided also that the provisions of the preceding proviso shall not apply to the premises for which licences have been issued by the licensing authority before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.] 1 [(3) Any person who is aggrieved by the order passed by the licensing authority in sub-Rule (1) may, within 30 days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, make such an order in relation thereto as it thinks fit.]

65. Condition of licences. Licences in 2 [Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B] shall be subject to the conditions stated therein and to the following general conditions

2 [(1) Any drug shall, if compounded or made on the licensee's premises be compounded or made by or under the direct and personal supervision of a³[registered Pharmacist].]

(2) The supply, otherwise than by way of wholesale dealing,⁴[* * *] of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a³[registered Pharmacist]. 5 [(3) (1) The supply of any drug 6 [other than those specified in Schedule X] on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription. The following particulars shall be entered in the register:^_

(a) serial number of the entry,

(b) the date of supply,

(c) the name and address of the prescriber, 7 [(d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use,

(e) the name of the drug or preparation and the quantity or in the case of a medicine made up by the licensee, the ingredients and quantities thereof,

(f) in the case of a drug specified in²[Schedule C or⁸[Schedule H and Schedule H1]] the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any,

(g) the signature of the³[registered Pharmacist] by or under whose supervision the medicine was made up or supplied:

1. Amended by F.1-9/60-D dt. 3-7-1961.

2. Subs. by G.S.R 462 (E), dt. 22-6-1982.

3 . Subs. by G.S.R 676 (E), dt. 6-9-1994.

4. Omitted by No. G.S.R 462(E), dt. 22-6-1982.

5. Subs. by S. O. 2139, dt. 5-6-1972.

6. Ins. by G.S.R. 462(E), dt. 22-6-1982.

7. Subs. by G.S.R. 926 dt. 16-7-1977.

8. Subs. by G.S.R 588 (E), dt. 30-08-2013.

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Drugs and Cosmetics Rules 1945 Provided that in the case of drugs which are not compounded in the premises and which are supplied from or in the original containers, the particulars specified in items (a) to (g) above may be entered in a cash or credit memo book, serially numbered and specially maintained for this purpose:

Provided further that if the medicine is supplied on a prescription on which the medicine has been supplied on a previous occasion and entries made in the prescription register, it shall be sufficient if the new entry in the register includes a serial number, the date of supply, the quantity supplied and a sufficient reference to an entry in the register recording the dispensing of the medicine on the previous occasion:

Provided also that it shall not be necessary to record the above details in the register or in the cash or credit memo particulars in respect of−

(i) any drugs supplied against prescription under the Employees State Insurance Scheme if all the above particulars are given in that prescription, and

(ii) any drug other than that specified in¹[Schedule C or⁴[Schedule H and Schedule H1]] if it is supplied in the original unopened container of the manufacturer and if the prescription is duly stamped at the time of supply with the name of the supplier and the date on which the supply was made and on condition that the provisions of sub-rule (4)(3) of this rule are complied with.

5 [(h) the supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.]

(2) The option to maintain a prescription register or a cash or credit memo book in respect of drugs and medicines which are supplied from or in the original container, shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of the licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained only in prescription register if it is satisfied that the entries in the carbon copy of the cash or credit memo book are not legible.]

2 [(4) (1) The supply by retail, otherwise than on a prescription of a drug specified in Schedule C³[* * *] shall be recorded at the time of supply either−

1. Subs. by G.S.R 462 (E), dt. 22-6-1982.

2. Ins. by Notfn. No. 1-63/61-D, dt. 17-7-1963.

3 . Omitted by G.S.R 462 (E), dt. 22-6-1982.

4. Subs. by G.S.R 588 (E), dt. 30-08-2013.

5. Ins. by G.S.R 588 (E), dt. 30-08-2013.

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Drugs and Cosmetics Rules 1945

(i) in a register specially maintained for the purpose in which the following particulars shall be entered :

(a) serial number of the entry,

(b) the date of supply,

(c) the name and address of the purchaser,

(d) the name of the drug and the quantity thereof,

(e) in the case of a drug specified in Schedule C, the name of the manufacturer, the batch number and the date of expiry of potency,

(f) the signature of the person under whose supervision the sale was effected, or

(ii) in a cash or credit memo book, serially numbered containing all the particulars specified in items (b) to (f) of sub-clause (i) above.

NOTE: The entries in the carbon copy of the cash or credit memo which is retained by the licensee shall be maintained in a legible manner.

(2) The option to maintain a register or a cash or credit memo book shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of a licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained in a register if it is satisfied that the entries in the carbon copy of the cash/credit memo book are not legible.

(3)(i) The supply by retail of any drug shall be made against a cash/credit memo which shall contain the following particulars :

(a) Name, address and sale licence number of the dealer, 1 [(b) Serial number of the cash/credit memo,

(c) the name and quantity of the drug supplied.]

(ii) Carbon copies of cash/credit memos shall be maintained by the licensee as record.

1. Ins. by G. S. R. No. 245, dt. 21-2-1976.

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Drugs and Cosmetics Rules 1945 1 [(4)(i) Records of purchase of a drug intended for sale or sold by retail shall be maintained by the licensee and such records shall show the following particulars, namely:

(a) the date of purchase,

(b) the name and address of the person from whom purchased and the number of the relevant licence held by him,

(c) the name of the drug, the quantity and the batch number, and

(d) the name of the manufacturer of the drug.

(ii) Purchase bills including cash or credit memo shall be serially numbered by the licensee and maintained by him in a chronological order.]

2 [(5)(1) Subject to the other provisions of these Rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act in which the following particulars shall be entered

(a) the date of sale,

(b) the name, address of the licensee to whom sold and his sale licence number. In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered Medical Practitioner for the purpose of supply to his patients the name and address of the authority, institution or the Registered Medical Practitioner as the case may be,

(c) the name of the drug, the quantity and the batch number,

(d) the name of the manufacturer, 3 [(e) the signature of the competent person under whose supervision the sale was effected.]

(2) Carbon copies of cash or credit memos specified in clause (1) shall be preserved as records for a period of three years from the date of the sale of the drug.

1. Subs. by G.S.R 1242 (E), dt. 17-9-1979.

2. Amended by F. 1-63/62-D, dt. 17-7-1963.

3. Ins. by G.S.R 496 (E), dt. 9-6-1995.

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Drugs and Cosmetics Rules 1945 1 [(3) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be maintained by the licensee and such records shall show the following particulars, namely:-

(a) the date of purchase,

(b) the name, address and the number of the relevant licence held by the person from whom purchased,

(c) the name of the drug, the quantity and the batch number, and

(d) the name of the manufacturer of the drug.

(ii) Purchase bills including cash or credit memos shall be serially numbered by the licensee and maintained by him in a chronological order.]

(6) The licensee shall produce for inspection by an Inspector appointed under the Act on demand all registers and records maintained under these Rules, and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed.

(7) Except where otherwise provided in these Rules, all registers and records maintained under these Rules shall be preserved for a period of not less than two years from the date of the last entry therein.

(8) Notwithstanding anything contained in this Rule it shall not be necessary to record particulars in a register specially maintained for the purpose if the particulars are recorded in any other register specially maintained under any other law for the time being in force.

2 [(9) (a) Substances specified in 3 [Schedule H and Schedule H1] or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years.

(b) The supply of drugs specified in³[Schedule H and Schedule H1] or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years.]

1. Subs. by G.S.R 1242(E), dt. 17-9-1979.

2. Subs. by G.S.R 462(E), dt. 22-6-1982.

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Drugs and Cosmetics Rules 1945

(10) For the purposes of clause (9) a prescription shall

(a) be in writing and be signed by the person giving it with his usual signature and be dated by him;

1 [(b) specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use;]

(c) indicate the total amount of the medicine to be supplied and the dose to be taken.

(11) The person dispensing a prescription containing a drug specified in 5 [Schedule H and Schedule H1] 2 [and Schedule X] shall comply with the following requirements in addition to other requirement of these rules.

(a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once;

(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions;

(c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed.

4 [(11-A) No person dispensing a prescription containing substances specified in 3 [ 5 [Schedule H and Schedule H1] or X], may supply any other preparation, whether containing the same substance or not, in lieu thereof.

3 [(12) Substances specified in Schedule X kept in retail shop or premises used in connection therewith shall be stored—

(a) under lock and key in cupboard or drawer reserved solely for the storage of these substances; or

(b) in a part of the premises separated from the remainder of the premises and to which only responsible persons have access;]

1. Subs. by G. S. R. No. 926, dt. 24-6-1977.

2. Ins. by G.S.R 462 (E), dt. 22-6-1982.

3. Subs., by G.S.R 462 (E), dt. 22-6-1982.

4. Ins. by SO 2139, dt. 5-6-1972.

5. Subs. by G.S.R 588(E), dt. 30-8-2013.

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Drugs and Cosmetics Rules 1945 1 [* * * * *]

2 [(15)(a) The description "Drugstore" shall be displayed by such licensees who do not require the services of a³[Registered Pharmacist].

(b) The description "Chemists and Druggists" shall be displayed by such licensees who employ the services of a³[Registered Pharmacist] but who do not maintain a "Pharmacy" for compounding against prescriptions.

(c) The description "Pharmacy", "Pharmacist", "Dispensing Chemist" or

"Pharmaceutical Chemist" shall be displayed by such licensees who employ the services of a³[Registered Pharmacist] and maintain a "Pharmacy" for compounding against prescriptions:

3 [Explanation:- For the purpose of this rule,-

(i) "Registered Pharmacist" means a person who is a registered Pharmacist as defined in clause (i) of section (2) of the Pharmacy Act, 1948 (Act No. 8 of 1948):

Provided that the provisions of sub-clause (i) shall not apply to those persons who are already approved as "qualified person" by the licensing authority on or before 31st December, 1969:

(ii) "Date of Expiry of potency" means the date that is recorded on the container, label or wrapper as the date up to which the substance may be expected to retain a potency not less than or not to acquire a toxicity greater than that required or permitted by the prescribed test].] 4 [(16) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]

1. Sub-Rules (13) and (14) omitted by G.S.R 462 (E), dt. 22-6-1982.

2. Subs. by Notfn. No. F. 1-16/57-D, dt. 15-6-1957.

3 . Subs. by G.S.R 676 (E), dt. 6-9-1994.

4. Subs. by Notfn. No. F. 1-14/68-D dt. 26-10-1968.

77

Drugs and Cosmetics Rules 1945 1 [(17) No drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper:

Provided that any such drugs in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks²[and all such drugs shall be kept in packages or cartons, the top of which shall display prominently, the words "Not for sale"].]

3 [(18) No drug intended for distribution to the medical profession as free sample which bears a label on the container as specified in clause⁴[(ix)] of sub-rule (1) of rule 96, and no drug meant for consumption by the Employees' State Insurance Corporation, the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government institutions, which bears a distinguishing mark or any inscription on the drug or on the label affixed to the container thereof indicating this purpose shall be sold or stocked by the licensee on his premises:]

5 [Provided that this sub-rule shall not be applicable to licensees who have been appointed as approved chemists, by the State Government in writing, under the employees' State Insurance Scheme, or have been appointed as authorised agent or distributor, by the manufacturer in writing, for drugs meant for consumption under the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government Institutions for drugs meant for consumption under those schemes⁶[or have been appointed as authorised Depots or Carrying and Forwarding agent by the manufacturer in writing, for storing free samples meant for distribution to medical profession] subject to the conditions that the stock shall be stored separately from the trade stocks and shall maintain separate records of the stocks received and distributed by them.]

1. Ins. by Notfn. No. F. 1-55/61-D, dt. 22-8-1964.

78

Drugs and Cosmetics Rules 1945 1 [(19) The supply by retail of any drug in a container other than the one in which the manufacturer has marketed the drug, shall be made only by dealers who employ the services of a²[Registered Pharmacist] and such supply shall be made under the direct supervision of the²[Registered Pharmacist] in an envelope or other suitable wrapper or container showing the following particulars on the label:

(a) name of the drug,

(b) the quantity supplied,

(c) the name and address of the dealer.] 3 [(20) The medicines for treatment of animals kept in a retail shop or premises shall be labelled with the words 'Not for human use for treatment of animals only' and shall be stored

(a) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or

(b) in a part of the premises separated from the remainder of the premises to which customers are not permitted to have access.] 4 [(21) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply in a register (bound and serially page numbered) specially maintained for the purpose and separate pages shall be allotted for each drug.

(b) The following particulars shall be entered in the said register, namely:--

(i) Date of transaction;

(ii) Quantity received, if any, the name and address of the supplier and the number of the relevant licence held by the supplier;

(iii) Name of the drug;

(iv) Quantity supplied;

(v) Manufacturer's name;

(vi) Batch No. or Lot No;

(vii) Name and address of the patient/purchaser;

(viii) Reference Number of the prescription against which supplies were made;

(ix) Bill No and date in respect of purchases and supplies made by him;

(x) Signature of the person under whose supervision the drugs have been supplied.]

1. Ins. by G. S. R. 444 dt. 28-4-1973.

2 . Subs. by G.S.R 676 (E), dt. 6-9-1994.

3. Added by G. S. R. No. 926 dt. 16-7-1977.

4. Ins. by G.S.R 462 (E), dt. 22-6-1982.

79

Drugs and Cosmetics Rules 1945 1 [65A. Additional information to be furnished by an applicant for liscence or a licensee to the Licensing Authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership of occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]

66. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder:

1 [Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority−

(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or

(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or

(c) if the act or omission was a continuing act or omission, he had not or could not reasonably have had knowledge of that previous act or omission, or

(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.] 2 [(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]

3 [66A. Procedure for disposal of drugs in the event of cancellation of licence.—

(1) In case a licensee, whose licence has been cancelled, desires to dispose of the drugs he has in his possession in the premises in respect of which the licence has been cancelled, he shall apply in writing to the licensing authority for this purpose, giving the following particulars, namely:—

1. Ins. by S. O. 2139, dt. 12-8-1972.

2. Subs. by G. S. R. 926 dt. 16-7-1977.

3. Ins. by G.S.R 1242 (E), dt. 17-9-1979.

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Drugs and Cosmetics Rules 1945

(a) the name and address of the person to whom the drugs are proposed to be sold or supplied together with the number of the licence for sale or manufacture, as the case may be, held by him,

(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry, if any, proposed to be sold to the person mentioned in clause (a).

(2) The licensing authority may, after examination of the particulars referred to in sub-rule (1) and, if necessary, after inspection by an Inspector of the premises where the drugs are stocked, grant the necessary permission for their disposal.] ⁶[****]

1 [PART VIA

SALE OF HOMOEOPATHIC MEDICINES

67A. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.

(2) Application for the grant or renewal of a licence²[to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority and shall be accompanied by a³[fee of rupees two hundred and fifty]:

4 [Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry the fee payable for renewal of such licence shall be

3 [rupees two hundred and fifty plus an additional fee at the rate of rupees fifty or part thereof].

5 [(3) If the original licence is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of a³[fee of rupees fifty].]

67B. A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licences and such other powers, as may be specified, to any other person under his control.

67C. Forms of licences to sell drugs. (1) A licence 2 [to sell, stock or exhibit or

offer for sale or distribute] Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or 20D as the case may be.

1. Added by Notfn. No. F. 1-35/64-D, dt. 18-8-1964.

2. Subs. by G.S.R 788(E) dt. 10-10-1985.

3 . Subs. by G.S.R 601 (E), dt. 24-8-2001.

4. Amended by S. O. 2139 dt. 12-8-1972.

5. Added by G. S. R. 665, dt. 28-5-77.

6. Rule 67 omitted by SO 289 (E), dt. 20-12-1972.

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67D. Sale at more than one place. If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate licence shall be obtained in respect of each place.

67E. Duration of licences. An original licence or a renewed licence unless it is sooner suspended or cancelled shall be¹[valid for a period of five years on and from the date on which] it is granted or renewed :

2 [Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six month of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry.]

3 [67EE. Certificate of renewal. The certificate of renewal of a sale licence in Forms 20C and 20D shall be issued in Form 20E.]

67F. Condition to be satisfied before a licence in Form 20C or Form 20D is granted.-(1) A licence in Form 20C or Form 20D to⁴[to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are clean and in the case of a licence in Form 20C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines:

5 [Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.]

(2) Any person who is aggrieved by the order passed by the Licensing Authority under sub-rule (1) may within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his case, make such order in relation thereto as it thinks fit.

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Drugs and Cosmetics Rules 1945

67G. Conditions of licence. Licence in Form 20C or 20D shall be subject to the conditions stated therein and to the following further conditions, namely:

(1) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition.

(2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines.

(3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed.

(4) The licensee in Form 20D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold.

1 [(5) The licensee in Form 20C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparation in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml. need be maintained.]

2 [(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.] 3 [67GG. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force as the case may be, documentary evidence in respect of the ownership or occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]

1. Ins. by Notfn. No. F. 1-59/68-D, dt. the 19-11-1969.

2. Ins. by G.S.R 331 (E), dt. 8-5-1984.

3. Ins. by S. O. 2139 dt. 5-6-1972.

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Drugs and Cosmetics Rules 1945

67-H. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder:

1 [Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the Licensing Authority−

(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or

(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or

(c) if the act or omission was a continuing act or omission that he had not or could not reasonably have had knowledge of that previous act or omission, or

(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.] 2 [(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]

1. Ins. by S. O. 2139 dt. 5-6-1972.

2. Amended by G.S.R. 926 dt. 16-7-1977.

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Drugs and Cosmetics Rules 1945

PART VII

1 [MANUFACTURE FOR SALE OR FOR DISTRIBUTION] OF DRUGS

OTHER THAN HOMOEOPATHIC MEDICINES

68. Manufacture on more than one set of premises. If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 2 [68-A. Grant or Renewal of Licences by the Central Licence Approving Authority.— (1) Notwithstanding anything contained in this Part, on and from the commencement of the Drugs and Cosmetics (Amendment) Rules,1992, a licence for the manufacture for sale or distribution of drugs as specified from time to time by the Central Government by notification in the Official Gazette, for the purpose of this rule, shall be granted or renewed, as the case may be, by the Central Licence Approving Authority (appointed by the Central Government):]

Provided that the application for the grant or renewal of such licence shall be made to the Licensing Authority.

(2) On receipt of the application for grant or renewal of a licence, the licensing authority shall,-

(i) verify the statement made in the application form;

(ii) cause the manufacturing and testing establishment to be inspected in accordance with the provisions of rule 79; and

(iii) in case the application is for the renewal of licence, call for the information(s) of the past performance of the licensee.

(3) If the licensing authority is satisfied that the applicant is in a position to fulfil the requirements laid down as in these Rules, he shall prepare a report to that effect and forward it along with the application³[and the licence (in triplicate) to be granted and renewed, duly completed] to the Central Licence Approving Authority:

Provided that if the licensing authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these Rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence, as the case may be.

(4) If on receipt of the application and the report of the licensing authority referred to in sub-rule (3) and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, with or without an expert in the concerned field if deemed necessary, the Central Licence Approving Authority, is satisfied that the applicant

1. Subs. by G.S.R 788 (E), dt. 10-10-1985.

2. Ins. by G.S.R 923 (E), dt. 14-12-1992.

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Drugs and Cosmetics Rules 1945 is in a position to fulfil the requirements laid down in these Rules, he may grant or renew the licence, as the case may be:

Provided that if the Central Licence Approving Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules, he may, notwithstanding the report of the licensing authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of licence, as the case may be.]

1 [68B. Delegation of Powers by the Central Licence Approving Authority.—The Central Licence Approving Authority may with the approval of the Central Government, by notification delegate his powers of signing licences and any other powers under the rules to any person under his control having same qualifications as prescribed for controlling authority under Rule 50A for such areas and for such periods as may be specified.]

2 [69. Application for licence to manufacture drugs other than those specified in Schedules C and C(I) to the Drugs and Cosmetics Rules. 3 [(1) Application for grant or renewal of⁴[licence to manufacture for sale or for distribution] of drugs, other than those specified in Schedules C and C(I) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made

(a) in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in, Form 24B;

(b) in the case of manufacture of drugs included in Schedule X, in Form 24F;

(c) in any other case, in Form 24.] 5 [(2)(a) Every application in Form 24B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees five hundred plus and an inspection fee of rupees two hundred for every inspection or for the purpose of renewal of the licence.

1. Ins. by G.S.R 89 (E), dt. 14-02-1996.

2. Amended by Notfn. F. 1-22/59-D, dt. 9-4-1960.

3. Subs. by G.S.R 462 (E), dt. 22-06-1982.

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Drugs and Cosmetics Rules 1945

(b) Every application in Form 24F shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every subsequent inspection or for the purpose of renewal of licence.

(c) Every application in Form 24 shall be made up to ten items for each category of drugs³[referred to in Schedule M relating to pharmaceuticals products and Schedule MIII relating to medical devices and in-vitro diagnostics] and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of one thousand and five hundred for every inspection or for the purpose of renewal of the licence.]

1 [(3) If a person applies for the renewal of a licence after the expiry thereof but within six months of such expiry the fee payable for the renewal of such licence shall be−]

2 [(i) in the case of Form 24B a licence fee of rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in addition to an inspection fee of rupees two hundred;

(ii) in the case of Form 24F a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand;

(iii) in the case of Form 24 a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand and five hundred.] 1 [(4) A fee 2 [rupees one thousand shall be paid] for a duplicate copy of the licence issued under clause (a), clause (b) or clause (c) of sub-Rule (1) if the original is defaced, damaged or lost.]

2 [(5) Applications for manufacture of more than ten items of each category of drugs as categorized under Schedule M and M-III or for manufacture of additional items of drugs by licensees in Form 24 or Form 24F shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drug. Applications in Form 24B for licence to manufacture for sale and distribution for repacking for more than 10 items of each category or for manufacture of additional item of drug shall be accompanied by additional fee of rupees one hundred for each additional item of drugs as cetegorized in Schedule M and M-III].

1. Subs. by G.S.R 462 (E), dt. 22-6-1982.

2. Subs. by G.S.R 26 (E), dt. 19-1-2006.

87

Drugs and Cosmetics Rules 1945 1 [(6) Where an application under this Rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122E, such application shall also be accompanied with approval, in writing in favour of the applicant, from the licensing authority as defined in clause (b) of rule 21.] 2 [69A. Loan Licences.⎯ 3 [(1) Application for the grant or renewal of loan licences to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C (1) and Schedule X shall be made up to ten items for each category of drugs⁵[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be made in Form 24A accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority:

Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or part thereof.]

4 [Explanation.- For the purpose of this rule a loan licence means a licence which the Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.]

(2) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.

3 [(3) Subject to the provisions of sub-rule (2), application for manufacture of more than ten items for each category of drug on a loan licence shall be accompanied by an additional fee of rupees three hundred per additional item specified⁵[referred to in Schedule M relating to pharmaceuticals products and Schedule MIII relating to medical devices and in-vitro diagnostics].

1. Ins. by G.S.R 311 (E), dt. 1-5-2002.

2. Amended by Notfn. No. F. 1-16/57-D, dt. 15-6- 1957.

3. Subs. by G.S.R 601(E) dt. 24-8-2001.

4. Subs. by G.S.R 724(E) dt. 07-11-2013.

5 . Subs. by G.S.R 640 (E), dt. 29-6-2016.

88

Drugs and Cosmetics Rules 1945 1 [(4) If the Licensing Authority is satisfied that a loan licence is defaced, damaged or lost or otherwise rendered useless, he may, on payment of a²[fee of rupees one thousand] issue a duplicate licence.]

3 [* * * * *]

4 [70. Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1).-

Licences for repacking of drugs against application in Form 24-B shall be granted in Form 25-B, licences for manufacture of drugs included in Schedule X and against application in Form 24-F shall be granted in Form 25-F and licences for manufacture of drugs against application in Form 24 shall be granted in Form 25.] 5 [70A. Form of loan 6 [licence to manufacture for sale or for distribution] of drugs other than those ⁷[specified in Schedules C, C(1) and X].⎯

A loan

6

[licence to manufacture for sale or for distribution] or drugs other than those 7 [specified in Schedules C, C(1) and X] shall be issued in Form 25A.] 8 [71. Conditions for the grant or renewal of a licence in Form 25 9 [or Form 25F].⎯

Before a licence in Form 25⁹[or Form 25F] is granted or renewed, the following conditions shall be complied with by the applicant.-

(1) The manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is

(a) a graduate in Pharmacy or Pharmaceutical Chemistry of¹⁰[a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] and has had at least eighteen months practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course; or

(b) a graduate in Science of¹⁰[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] who for the purpose of his degree has studied Chemistry as a principal subject and has

1. Ins. by Notfn. No. F.1-20/64-D, dt. 26.10.1968.

2. Subs. by Notfn. No. G.S.R. 601 (E), dt. 24.8.2001.

3. Rule 69 omitted by G.S.R. 944 (E), dt. 21-9-1988.

4. Subs. by Notfn. No. G.S.R. 462 (E), dt. 22.6.1982.

5. Ins. by Notfn. No. F.1-16/57 D, 15-6-1957 & No. F.1/22/59-D, dt. 9.4.1960.

6. Subs. by Notfn. No. G.S.R. 788 (E), dt. 10-10-1985.

7. Subs. by Notfn. No. G.S.R. 462 (E), dt. 22-6-1982.

8. Subs. by Notfn. No. F.1-16/57-D, dt. 15-6-1957.

9. Ins. by G.S.R. 462(E), dt. 22-6-1982.

10 . Subs. by Notfn. No. G.S.R. 71 (E), dt. 30-1-1987.

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Drugs and Cosmetics Rules 1945 had at least three years practical experience in the manufacture of drugs after his graduation; or

(c) a graduate in Chemical Engineering or Chemical Technology or Medicine of¹[a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or 2 [(d) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b) or clause

(c) and is permitted to work as competent technical staff under this Rule by the Central Government:]

Provided that any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any licence granted in Form 25³[or Form 25F] as it existed before the date shall be deemed to be qualified for the purposes of this rule:

4 [Provided further that for drugs other than those specified in Schedules C, C(1) and X and meant for veterinary use, the whole-time employee under whose supervision the manufacture is conducted shall be a graduate in Veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years practical experience in the manufacture of drugs excluding graduate in Pharmacy who shall have at least eighteen months practical experience in the manufacture of drugs:] 5 [Provided 6 [also] that the Licensing Authority may, in the matter of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of Paris and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included in clause (a), (b) or (c) of this rule, has, in the opinion of the Licensing Authority, adequate experience in the manufacture of such substance.]

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Drugs and Cosmetics Rules 1945

(2) The factory premises shall comply with the conditions prescribed in Schedule M.

(3) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; the space, plant and equipment recommended for various operations are given in Schedule M.

1 [(4) The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit, which shall be separate from the manufacturing unit and the head of the testing unit shall be independent of the head of the manufacturing unit :

Provided that the manufacturing units, which, before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements up to the 30th June, 1977 :

Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it⁴

[ under Part XV(A) of these rules] for this purpose.] 2 [(4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate.]

(5) The applicant shall make adequate arrangements for the storage of drugs manufactured by him.

3 [(6) The applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;

1. Subs. by G.S.R. 926 dt. 16-7-1977.

2. Ins. by G.S.R. 681(E), dt. 5-12-1980.

3. Ins. by G.S.R. 515 dt. 10-4-1976.

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(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation and under the conditions in which the formulation for administration and use are recommended;

(iii) are stable under the conditions of storage recommended;

(iv) contain such ingredients and in such quantities for which there is therapeutic justification; and]

1 [(v) have the approval, in writing, in favour of the applicant to manufacture drugs formulations falling under the purview of new drug as defined in Rule 122-E, from the Licensing Authority as defined in clause (b) of rule 21.] 2 [(7) The licensee shall comply with the requirements of Good Manufacturing Practices as laid down in Schedule M.]

6 [(8) The applicant shall make application for grant of licence for a drug formulation containing single active ingredient only in proper name.]

3 [71A. Conditions for the grant or renewal of a licence in Form 25B. Before a licence in Form 25B is granted or renewed the following conditions shall be complied with by the applicant :-

(1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person;

4 [(2) the factory premises shall comply with the conditions prescribed in Schedule M; and]

5 [(3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit:]

6 [(4) The application for grant of licence for a drug formulation containing single active ingredient shall be made only in proper name:]

Provided that the repacking units, which before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1977, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf, may continue such arrangements up to the 31st July, 1977:

1. Ins. by G.S.R. 311 (E), dt. 1-5-2002.

2. Ins. by G.S.R. 735 (E), dt. 24-6-1988.

3. Ins. by No. F.1-22/59-D, dt. 9-4-1960.

4. Amended by S.O. 2139 dt. 12-8-1972.

5. Amended by G.S.R. 926 dt. 16-7-1977.

6. Ins. by G.S.R. 570 (E), dt. 7-8-2014.

92

Drugs and Cosmetics Rules 1945 Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may permit such test to be conducted by institutions approved by it under Part XV(A) of these Rules for this purpose.]

Explanation.−A person who satisfies the following minimum qualifications shall be deemed to be a "competent person" for the purposes of rule 71A or 74A of these rules, namely: −

(a) a person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is registered under the said Act, or

(b) a person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the Licensing Authority as equivalent to it; or

(c) a person who has passed the Matriculation examination or an examination recognized by the Licensing Authority as equivalent to it and has had not less than four years' practical experience in the manufacture, dispensing or repacking of drugs.]

1 [71B. Conditions for the grant of renewal of a licence in Form 25A.− Before a licence in Form 25A is granted or renewed, the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines:-

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;

(ii) are safe for use in the context of the vehicles, recipients, additives and pharmaceutical aids used in the formulations and under conditions in which the formulations for administration and use are recommended;

(iii) are stable under the conditions of storage recommended; and

(iv) contain such ingredients and in such quantities for which there is therapeutic justification.

2 [Provided that the application for grant of a licence for a drug formulation containing single active ingredient shall be made only in proper name.]

1. Ins. by G.S.R. 515 (E), dt. 24-3-1976.

2. Ins. by G.S.R. 570 (E), dt. 7-8-2014.

93

Drugs and Cosmetics Rules 1945 1 [72. Duration of licence.-An original licence or a renewed licence in Form 25,²[Form 25B or Form 25F] unless sooner suspended or cancelled shall be 3 [valid for a period of five years on and from the date on which] it is granted or renewed:

4

[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]

2 [73. Certificate of renewal.- The certificate of renewal of a licence in Form 25 or Form 25F shall be issued in Form 26 or Form 26E respectively].

5 [73A. A certificate of renewal of loan licence.- The certificate of renewal of a loan licence in Form 25A shall be issued in Form 26A.]

5 [73AA. Duration of loan licence.- An original loan licence in Form 25A or a renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 3 [valid for a period of five years on and from the date on which] it is granted or renewed:]

6 [Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]

7 [73B. Certificate of renewal of licence in Form 25B.-The certificate of renewal of a licence in Form 25B shall be issued in Form 26B.]

1. Subs. by Notfn. No. F.1-10/62-D, dt. 10-4-1964.

94

Drugs and Cosmetics Rules 1945 1 [74. Conditions of licence in Form 25.−A licence in 2 [Form 25 and Form 25F] shall be subject to the conditions stated therein and to the following further conditions, namely :

(a) the licensee shall provide and maintain staff, premises and the equipment as specified in rule 71;

(b) the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the Rules, these would come into force, four months after publication in the Official Gazette;

(c) the licensee shall either in his own laboratory or in any other laboratory approved by the Licensing Authority⁴

[under Part XV (A) of these rules] test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of 5 years from the date of manufacture;

(d) the licensee shall keep records of the details of manufacture as per particulars given in Schedule U of each batch of the drugs manufactured by him and such records shall be retained for a period of five years;

(e) the licensee shall allow an³[ Inspector appointed under the Act], to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture and the means employed in standardizing and testing the drugs;

(f) the licensee shall allow an³[ Inspector appointed under the Act] to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules thereunder have been observed;

(g) the licensee shall, from time to time, report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the drugs and any material alterations in the premises or plant used for the purpose which have been made since the date of the last inspection made on behalf of the licensing authority;

1. Subs. by Notfn. No. F. 1-20/64-D (S.O. 3868), dt. 26-10-1968.

2. Subs. by G.S.R. 462 (E), dt. 22-6-1982.

3 . Amended by G.S.R. 444 dt. 28-4-1973 .

4. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.

95

Drugs and Cosmetics Rules 1945 1 [ (h) the licensee shall, on request, furnish to the Licensing Authority, the Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct from every batch, or batches of drugs as the Licensing Authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of tests which have been applied;]

(i) if the Licensing Authority²[or the Controlling Authority] so directs and if requested by the licensee who had also furnished prima facie reasons for such directions, the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under clause (h) until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the Licensing Authority²[or the Controlling Authority;

(j) the licensee shall on being informed by the Licensing Authority²[or the Controlling Authority] that any part of any batch of the drug has been found by the Licensing Authority²[or the Controlling Authority]not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch;

(k) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed; 1 [(l) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;]

2 [(m) the licensee, who has been granted a licence in Form 2 5F, shall-

(i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months;

(ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later:-

1. Subs. by G.S.R. No. 444 dt. 31-3-1973.

2 . Ins. by G.S.R. No. 444 dt. 31-3-1973.

3. Ins. by G.S.R. 462 (E), dt. 22-6-1982.

96

Drugs and Cosmetics Rules 1945 A. Accounts of the drugs specified in Schedule X used for the manufacture:

1. Date of issue.

2. Name of the drug.

3. Opening balance of stock on the production day.

4. Quantity received, if any, and source from where received.

5. Quantity used in manufacture.

6. Balance quantity on hand at the end of the production day.

7. Signature of the person in charge. B. Accounts of production:

1. Date of manufacture.

2. Name of the drug.

3. Batch Number.

4. Quantity of raw material used in manufacture.

5. Anticipated yield.

6. Actual yield,

7 Wastage,

8. Quantity of the manufactured goods transferred. C. Accounts of the manufactured drugs:

1. Date of manufacture.

2. Name of the drug.

3. Batch Number.

4. Opening Balance.

5. Quantity manufactured.

6. Quantity sold.

7. Name of the purchaser and his address.

8. Balance quantity at the end of the day.

9. Signature of the person in charge.

(n) the licensee shall store drugs specified in Schedule X in bulk form and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person;]

1 [(o) the licensee shall comply with the requirements of 2 [Good Laboratory Practices as laid down in Schedule L-I and] 'Good Manufacturing Practices' as laid down in Schedule M.] 3 [(p) No advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with the previous sanction of the Central Government.]

1. Ins. by G.S.R. 735 (E), dt. 24-6-1988.

2. Ins by G.S.R. 780 (E), dt. 10-11-2008.

3. Ins by G.S.R. 289 (E), dt. 15-04-2015.

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Drugs and Cosmetics Rules 1945

74A. Conditions for licence in Form 25B.^_ A licence in Form 25B shall be subject to the conditions stated therein and to the following conditions:^_

(a) the repacking of drugs shall at all times be conducted under the personal supervision of at least one person who is approved as a competent person by the Licensing Authority;

(b) the licensee shall either provide and maintain adequate arrangements in his own premises for carrying out tests of the strength, quality and purity of the drugs repacked or make arrangements with some institution approved by the Licensing Authority³[under Part XV (A) of these rules] for such tests to be regularly carried out on his behalf by the institution;

(c) the licensee shall make adequate arrangements for the storage of drugs; 2 [(d) the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act:

Provided that where such further requirements are specified in the Rules, these would come into force four months after publication in the Official Gazette.]

(e) the licensee shall allow any⁴[Inspector appointed under the Act] to enter with or without notice, any premises where the packing of drugs in respect of which the licence is issued is carried on, to inspect the premises and to take samples of repacked drugs;

2 [(f) the licensee shall, either in his own laboratory or, in any other laboratory approved by the Licensing Authority, test each batch or lot of raw material used by him for repacking and also each batch of the product thus repacked and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of repacking. The licensee shall allow the Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed;]

1. Ins. by G.S.R. 735 (E), dt. 24-6-1988.

2. Subs. by Notfn. No. F.1-20/64-D, dt. 26-10-1968.

98

Drugs and Cosmetics Rules 1945 1 [(g) the licensee shall maintain an Inspection Book, in Form 35, to enable an Inspector to record his impressions and the defects noticed;] 2 [(h) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference sample shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.

4 [(i) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.]

3 [74B.Conditions of licence in Form 25A. (1) The licence in Form 25A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25, whose manufacturing facilities have been availed of by the licensee, is cancelled or suspended, as the case may be, under these rules.

(2) The licensee shall comply with the provisions of the Act and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.

(3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed.

1. Ins. by Notfn. No. 1-14/68-D, dt. 26-10-1968.

2. Ins. by G.S.R. 444 (E) dt. 31-3-1973 .

3. Subs. by Notfn. No. F. 1-14/68-D, dt. the 26-10-1968.

4. Ins. by G.S.R. 289 (E) dt. 15-4-2015.

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Drugs and Cosmetics Rules 1945

(4) The licensee shall either-

(i) provide and maintain to the satisfaction of the Licensing Authority adequate staff and adequate laboratory facilities for carrying out test of the strength, quality and purity of the substances manufactured by him, or

(ii) make arrangements with some institution approved by the Licensing Authority⁷[under Part XV (A) of these rules] for such tests to be regularly carried out on his behalf by the institution.

1 [(5) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.]

2 [(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.] 8 [(7) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.]

3 [75. Form of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C(1) and X ⁴[excluding those specified in Part XB and Schedule X].^_(1) Applications for the grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C and C(1)⁴[excluding those specified in Part X-B and Schedule X], shall be made to the Licensing Authority in Form 27 and⁵[shall be made up to ten items for each category of drugs⁶[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences:] Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry, the fee payable for renewal of the licence shall be 5 [a licence fee of rupees six thousand plus an additional fee of rupees one thousand per month or a part thereof in addition to an inspection fee of rupees one thousand and five hundred.]

(2) Application for grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C, C(1) and X shall be made to the licensing authority in Form 27-B, and⁵[shall be made up to ten items for each category of drugs⁶[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purpose of renewal of licences]:

1. Ins. by G.S.R.. No. 444, dt. 28-4-1973. 7. Subs. by G.S.R. 1172(E), dt. 23-8-1977.

2. Ins. by G.S.R. 331 (E), dt. 8-5-1984. 8. Ins. by G.S.R. 289(E), dt. 15-4-2015.

3. Subs. by G.S.R. 462 (E), dt. 22-6-1982.

4. Subs. by G.S.R. 28(E), dt. 22-1-1993.

5 . Subs. by G.S.R. 601(E), dt. 24-8-2001.

6 . Subs. by G.S.R. 6 40(E), dt. 29-6 -2016 .

100

Drugs and Cosmetics Rules 1945 Provided that the applicant shall possess a licence in Form 28 to manufacture such drugs:

Provided further that if the application for renewal of a licence is made after its expiry but within six months of such expiry, the fee payable for renewal of the licence shall be¹[rupees six thousand plus an additional fee of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand five hundred.]

2 [(3) The application for grant or renewal of licence to manufacture for sale or for distribution of drugs in⁴[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] shall be made to the licensing authority appointed under this Part in Form 27D and¹[shall be made up to ten items for each category of drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purposes of renewal of licences:] Provided that if the application for renewal of a licence is made after its expiry but within six months of such expiry, the fee payable for renewal of the licence¹[shall be rupees six thousand plus an additional fee of rupees one thousand per month or a part thereof in addition to the inspection fee of rupees one thousand and five hundred.]

1 [(4) A fee of rupees one thousand shall be paid for duplicate copy of the licence issued under sub-rule (1), sub-rule (2) or sub-rule (3), as the case may be, if the original licence is defaced, damaged or lost.

(5) If the licensee applies for manufacture of more than ten items of each category of drugs, the application shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs⁵[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics].]

3 [(6) Where an application under this Rule is for the manufacture of drug formulations falling under the purview of new drugs as defined in Rule 122-E, such application shall also be accompanied with approval, in writing, in favour of the applicant, from the licensing authority as defined in clause (b) of Rule 21.]]

1 . Subs. by G.S.R. 601 (E), dt. 24-8-2001 .

2. Ins. by G.S.R. 119 (E), dt. 11-3-1996.

3. Ins. by G.S.R. 311 (E), dt. 1-5-2002.

4. Subs. by G.S.R. 26 (E), dt. 19-1-2006.

5 . Subs. by G.S.R. 640 (E), dt. 29-6-2016.

101

Drugs and Cosmetics Rules 1945 1 [75A. Loan licences.−(1) Applications for the grant or renewal of loan 2 [licences for the manufacture for sale or for distribution] of drugs specified in Schedules C and C(1)³[excluding those specified in Part X-B and Schedule X] shall be made in Form 27-A to the licensing authority and⁴[shall be made upto ten items for each category of drugs¹⁴[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences:]

5 [Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry the fee payable for renewal of the licence shall be⁴[rupees six thousand and an inspection of fee of rupees one thousand five hundred plus an additional fee at the rate of rupees one thousand] per month or a part thereof.] 11 [Explanation. − For the purpose of this rule a loan licence means a licence which a licensing authority may issue to an applicant who intends to avail the manufacturing facilities owned by a licensee in Form 28.]

12 [(1A) The application for grant or renewal of loan license to manufacture for sale or distribution of drugs in 'Large Volume Parenterals', 'Sera and Vaccine' and 'Recombinant DNA (r-DNA) derived drugs' shall be made to the licensing authority appointed under this Part, in Form 27DA and be made upto ten items for each category of drugs categorized in Schedule M and accompanied by a license fee of six thousand rupees and an inspection fee of one thousand five hundred rupees for every inspection or for the purpose of renewal of licenses:

Provided that if the application for renewal of a license is made after its expiry but within six months of such expiry, the fee payable for renewal of the license shall be six thousand rupees plus an additional fee of one thousand rupees per month or a part thereof in addition to the inspection fee of one thousand and five hundred rupees;]

(2) The licensing authority, shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing to undertake the manufacture on behalf of the applicant for a loan licence.

13 [***]

4 [(3) Subject to the provisions of sub-rule (2), the application for manufacture of more than ten items of each category of drugs on a loan license, shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs.

(4) If the licensing authority is satisfied that a loan licence is defaced, damaged or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan licence.]

6 [* * * * *]

7 [76. 8 [Forms of licence to manufacture drugs specified in Schedules C and C(1), 9 [excluding those specified in Part XB and Schedule X], or drugs specified in Schedules C, C(1) and X and the conditions for the grant or renewal of such licences.- ¹⁰[A licence to manufacture for sale or for distribution of drugs specified in

1. Ins. by F.1-16/57-D, dt. 15-6-1957.

2. Subs. by G.S.R 788 (E), dt. 10-10-1985.

3. Subs. by G.S.R 28 (E), dt. 22-1-1993.

4 . Subs. by G.S.R 601 (E), dt. 24 -8-2001.

5. Amended by S.O.2139 dt. 13-8-1972.

6. Rule 75B omitted by G.S.R. 944 (E), dt. 21-9-1988.

7. Amended by F- 1- /57-D, dt. 15-6-1969.

8. Subs. by G.S.R. 462 (E), dt. 22-6-1982.

9. Subs. by G.S.R. 28 (E) , dt. 22.1.1993.

10 . Subs. by G.S.R. 119 (E), dt. 11-3-1996.

11. Subs. by G.S.R. 724 (E), dt. 7-11-2013.

12. Ins. by G.S.R. 574 (E) , dt. 17.7.2012.

13. Proviso omitted by G.S.R. 574 (E) , dt. 17.7.2012.

14. Subs. by G.S.R. 640 (E), dt. 29-06-2016.

102

Drugs and Cosmetics Rules 1945 Schedules C and C(1) other than⁴[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] specified in Part X B and Schedule X shall be issued in Form 28 and a licence to manufacture for sale or distribution of drugs specified under Schedules C and C(1) (other than⁴[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] specified in Part X-B) and Schedule X shall be issued in Form 28B. A licence to manufacture for sale or for distribution of⁴[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] shall be issued in Form 28-D. Before a licence in Form 28 or Form 28B or Form 28D is granted or renewed, the following conditions shall be complied with by the applicant:-

(1) The manufacture will be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole time employee and who is

(a) a graduate in Pharmacy or Pharmaceutical Chemistry of¹[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had at least eighteen months' practical experience after the graduation in the manufacture of drugs to which this licence applies; this period of experience may however be reduced by six months if the person has undergone training in manufacture of drugs to which the licence applies for a period of six months during his University course; or

(b) a graduate in Science of¹[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] who for the purpose of his degree has studied Chemistry³[or Microbiology] as a principal subject and has had at least three years' practical experience in the manufacture of drugs to which this licence applies after his graduation; or

(c) a graduate in Medicine of¹[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] with at least three years' experience in the manufacture and pharmacological testing of biological products after his graduation; or

2 [(d) a graduate in Chemical Engineering of a University recognised by the Central Government with at least three years' practical experience in the manufacture of drugs to which this licence applies after his graduation; or

(e) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b), clause (c) or clause (d) and is permitted to work as competent technical staff under this Rule by the Central Government.]

1 . Subs. by G.S.R. 71 (E), dt. 30-1 -1 987.

2. Ins. by F.1-19/59-D, dt. 13-6-1967.

3. Ins. by G.S.R. 245(E), dt. 3-2-1976.

4. Subs. by G.S.R. 26 (E), dt. 19-1-2006.

103

Drugs and Cosmetics Rules 1945 Provided that any person who was approved by the licensing authority as an expert responsible for the manufacture of drugs for the purpose of rule 76 read with Rule 78 as these Rules were in force immediately before the 29th June, 1957, shall be deemed to be qualified for the purposes of this rule:

1 [Provided that for the drugs specified in Schedules C and C(1) meant for veterinary use, the whole time employee under whose supervision the manufacture is conducted may be a graduate in Veterinary Science or general science or medicine or pharmacy of a University, recognized by the Central Government and who has had at least three years' experience in the manufacture of biological products:

5 [Provided also that for medical devices, the whole time employee under whose supervision the manufacture or testing is conducted shall be—

(i) a graduate in Pharmacy or Engineering (in appropriate branch) from a University recognised by the Central Government for such purposes and has had at least eighteen months practical experience in the manufacturing or testing of devices to which this licence applies after his graduation; or

(ii) a graduate in science, from a University recognised by the Central Government for such purposes, with Physics or Chemistry or Microbiology as one of the subject and has had at least three years practical experience in the manufacturing or testing of devices to which this licence applies after his graduation; or

(iii) a diploma in Pharmacy or Engineering (in appropriate branch) from a Board or Institute recognised by the Central Government or the State Government, as the case may be, for such purposes and has had at least four years practical experience in the manufacturing or testing of devices to which this licence applies after his diploma; or

(iv) having a foreign qualification, the quality and content of training of which are comparable with those specified in clause (i), clause (ii) and clause (iii) and is permitted to work as competent technical staff under this rule by the Central Government.]

6 [(2) The applicant proposing to manufacture pharmaceutical products shall comply with the provisions referred to in Schedule M.

(2A) The applicant proposing to manufacture medical devices and in-vitro diagnostics shall comply with the quality management system as referred to in Schedule M-III.

(3) The applicant shall provide adequate space, plant and equipment for pharmaceutical products as referred to in Schedule M and for Medical devices and in- vitro diagnostics as referred to in Schedule M-III.]

3 [(4) The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out such tests of the strength, quality and purity of the substances as may be required to be carried out by him under the provisions of Part X of these rules including proper housing for animals used for the purposes of such tests, the testing unit being separate from the manufacturing unit and the head of the testing unit being independent of the head of the manufacturing unit:

Provided that the manufacturing units which before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977⁴, were making arrangements with institutions approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements upto the 30th June, 1977 :

Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it²[under Part XV (A) of these rules] for this purpose.

1. Ins. by F.1-6/62-D (SO 2889), dt. 2-7-1969.

2 . Ins. by G.S.R 1172 (E), dt. 2 3-8-1977.

3. Sub. by G.S.R 926 (E), dt. 24-6-1977.

4. These rules came in to force on 28^thMay, 1977 vide G.S.R 665 (E), dt. 6-5-1977.

5. Sub. by G.S.R 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R 109 (E), dt. 22-2-1994.

6. Sub. by G.S.R 640 (E), dt. 29-6-2016.

104

Drugs and Cosmetics Rules 1945 1 [(4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the Licensing authority is considered adequate.]

(5) The applicant shall make adequate arrangements for the storage of drugs manufactured by him.

2 [(6) The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be printed on the labels of such drugs on the basis of the data so furnished.]

3 [(7) The applicant shall, while applying for licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines−

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;

(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended;

(iii) are stable under the conditions of storage recommended;

(iv) contain such ingredients and in such quantities for which there is therapeutic justification.;] and

4 [(v) have the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug as defined in Rule 122E, from the licensing authority as defined in clause (b) of rule 21.]

5 [(8) The licensee of pharmaceutical products shall comply with the requirements of 'Good Manufacturing Practices' as laid down in Schedule M and the licensee of Medical Devices and in-vitro diagnostics shall comply with the requirements of

"Quality Management System" as laid down in Schedule M-III..]

1. Ins. by G.S.R 681 (E), dt. 5-12-1980.

2. Ins. by G.S.R 444 dt. 31-3-1973.

3. Ins. by G.S.R 515 dt. 24-3-1976.

4. Ins. by G.S.R 311 (E), dt. 1-5-2002.

5. Subs. by G.S.R 640 (E), dt. 29-06-2016. Previously Ins. by G.S.R 735 (E), dt. 24-6-1988.

105

Drugs and Cosmetics Rules 1945 1 [Explanation:- For the purpose of this rule, 6 ["Large Volume Parenterals" sera and vaccines and recombinant DNA (r-DNA) derived drugs,] shall mean the sterile solutions intended for parenteral administration with a volume of 100 ml. or more (and shall include anti-coagulant solutions) in one container of the finished dosage form intended for single use.]

⁷[(9) The applicant shall make application for grant of licence for a drug formulation containing single active ingredient only in proper name.]

2 [76A. Forms of loan licenses to manufacture for sale or for distribution drugs specified in Schedule C and C(1) excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant or renewal of such license.— A loan license to manufacture for sale or for distribution of drugs specified in Schedules C and C(1), excluding drugs specified in Schedule X, and Large Volume Parenterals, Sera and Vaccine and Recombinant DNA(r- DNA) derived drugs specified in Part XB shall be issued in Form 28A and a loan license to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs shall be issued in Form 28DA, and the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines-

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;

(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations, and under the conditions in which the formulations for administration and use are recommended;

(iii) are stable under the conditions of storage recommended; and

(iv) contain such ingredients and in such quantities for which there is therapeutic justification.]

106

Drugs and Cosmetics Rules 1945 1 [Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]

2 [78. Conditions of licence.−A licence in 3 [Form 28, Form 28B or Form 28D] shall be subject to the special conditions, if any, set out in Schedule F or ScheduleF(1), as the case may be, which relate to the substance in respect of which the licence is granted and to the following general conditions:−

(a) (i) The licensee shall provide and maintain an adequate staff and adequate premises and plant for the proper manufacture and storage of the substances in respect of which the licence is issued;

(ii) Without prejudice to the generality of the foregoing requirement, every holder of a licence who for any purpose engaged in the culture or manipulation of pathogenic spore-bearing micro-organisms shall provide to the satisfaction of the Licensing Authority separate laboratories and utensils and apparatus required for the culture or manipulation of such micro-organisms, the laboratories, utensils and apparatus so provided not being used for the manufacture of any other substance;

4 [(b) The licensee shall provide and maintain staff, premises and equipment as specified in Rule 76;]

5 [(c)(i) The licensee shall maintain records of manufacture as per particulars given in Schedule U;

(ii) The licensee shall either in his own laboratory or in any laboratory approved by the Licensing Authority⁶

[under Part XV (A) of these rules] test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained in the case of a substance for which a potency date is fixed for a period of two years from the expiry of such date, and in the case of other substances for a period of five years from the date of manufacture;]

(d) The licensee shall allow an⁷[Inspector appointed under the Act] to enter, with or without prior notice, any premises where the manufacture is carried on and to inspect the premises, and in the case of substances specified in Schedules C and C(1), to inspect the plant and the process of manufacture and the means employed for standardizing and testing the substance;]

1. Amended by S.O. 2139 dt. 12-8-1972.

2. Amended by F.1-6/62-B, dt. 2-6-1969.

3. Subs. by G.S.R. 119 (E), dt. 11-3-1996.

4. Amended by F.1-16/57-D (SO 2136), dt. 15-6-1957.

5. Amended by F.1-20/64-D (SO 3868), dt. 26-10-1968.

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(e) The licensee shall allow an¹[Inspector appointed under the Act] to inspect all registers and records maintained under these Rules and to take samples of the manufactured product and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed;]

(f) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the substance and any material alterations in the premises or plant used for that purpose which have been made since the date of the last inspection made on behalf of the Licensing Authority before the issue of the licence; 1 [(g) The licensee shall on request furnish to the Licensing Authority, Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct, from every batch of drug as the Licensing Authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish, full protocols of the tests which have been applied;]

2 [(h) If the Licensing Authority or the Controlling Authority so directs, the licensee shall not sell or offer for sale any batch in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorising the sale of the batch has been issued to him by or on behalf of the Licensing Authority or the Controlling Authority;] 1 [(i) The licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch of the substance has been found by the Licensing Authority or the Controlling Authority not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of that batch from sale and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch;]

(j) No drug manufactured under the licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture;

3 [(k) The licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette;]

108

Drugs and Cosmetics Rules 1945 1 [(l) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and defects noticed.] 2 [(m) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry is specified on the label the reference samples shall be maintained for a period of three years from the date of manufacture.]

3 [(n) The licensee, who has been granted a license in Form 28B shall−

(i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and Nursing Homes and Registered Medical Practitioners every three months;

(ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later.

A. Accounts of the drugs specified in Schedule X used for the manufacture:-

1. Date of issue.

2. Name of the drug.

3. Opening balance of stock on the production day.

4. Quantity received, if any, and source from where received.

5. Quantity used in manufacture.

6. Balance quantity on hand at the end of the production day.

7. Signature of the person in charge.

1. Subs. by F.1-14/68-B (SO3868), dt. 26-10-1968.

2. Ins. by G.S.R. 444, dt. 28-4-1973.

3. Ins. by G.S.R. 462 (E), dt. 22-6-1982.

109

Drugs and Cosmetics Rules 1945 B. Accounts of Production:

1. Date of manufacture.

2. Name of the drug.

3. Batch Number.

4. Quantity of raw material used in manufacture.

5. Anticipated yield.

6. Actual yield.

7 Wastage.

8. Quantity of the manufactured goods transferred. C. Accounts of the manufactured drugs:

1. Date of manufacture.

2. Name of the drug.

3. Batch Number.

4. Opening Balance.

5. Quantity manufactured.

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(2) The licensee shall comply with the provisions of the Act, and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, those would come into force four months after publication in the Official Gazette.

(3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. Records or registers shall be retained, in the case of a substance for which a potency date is fixed, for a period of two years from the expiry of such date and in the case of other substances, for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed.

(4) The licensee shall either (i) provide and maintain to the satisfaction of the Licensing Authority adequate staff and adequate laboratory facilities for carrying out tests of the strength, quality and purity of the substances manufactured by him, or (ii) make arrangements with some institution approved by the Licensing Authority for such tests to be regularly carried out on his behalf by the institution.] 1 [(5) The licensee shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which would be printed on the labels of such drugs on the basis of the data so furnished.]

2 [(6) The licensee shall maintain reference samples from each batch of the drug manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the labels, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.]

3 [(7) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.] 4 [(8) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.

5 [79. Inspection before grant or renewal of licence.−Before a licence under

1. Ins. by G.S.R. 444, dt. 28-4-1973.

2. Subs. by G.S.R. 574 (E), dt. 17-7-2012.

3. Ins. by G.S.R. 331 (E), dt. 8-5-1984.

4. Ins. by G.S.R. 289 (E), dt. 15-4-2015.

5. Subs. by G.S.R. 923 (E), dt. 14-12-1992.

111

Drugs and Cosmetics Rules 1945 this Part is granted or renewed the Licensing Authority or Central Licence Approving Authority, as the case may be, shall cause the establishment in which the manufacture is proposed to be conducted or being conducted to be inspected by one or more Inspectors appointed under this Act with or without an expert in the concerned field. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the 'Requirements of Good Manufacturing Practices' and the 'Requirements of Plant and Equipment' as laid down in Schedule M read with the Requirements of Maintenance of Records as laid down in Schedule U.]

1 [80. Report by Inspector.−The Inspector shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendations after completion of his inspection in accordance with the provisions of Rule 79, to the Licensing Authority or Central Licence Approving Authority, as the case may be.]

81. Procedure of Licensing Authority.−(1) If the Licensing Authority⁵[or Central Licence Approving Authority, as the case may be,] after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the Rules under the Act have been complied with and that the conditions of the licence and the Rules under the Act will be observed, he²[shall issue a licence under this Part].

(2) If the Licensing Authority⁵[or Central Licence Approving Authority, as the case may be,] is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted and shall supply the applicant with a copy of the inspection report.

3 [82. Further application after rejection. −If within a period of six months from the rejection of an application for a licence the applicant informs the Licensing Authority⁵[or Central Licence Approving Authority, as the case may be,] that the conditions laid down have been satisfied and deposits an inspection⁴[fee of rupees two hundred and fifty] the Licensing Authority⁵[or Central Licence Approving Authority, as the case may be,] may, if after causing a further inspection to be made, he is satisfied that the conditions for the grant of a licence have been complied with,

5 [in respect of drugs notified under Rule 68-A] issue a licence in Form 28 2 [or Form 28-B].

1. Subs. by G.S.R. 923 (E), dt. 14-12-1992.

2. Ins. by G.S.R. 462 (E), dt. 22-6-1982.

3. Ins. by F.1-16/57-D, dt. 15-6-1957.

4 . Subs. by G.S.R. 601 (E), dt. 24 -8-2001.

5 . Ins. by G.S.R. 923 (E), dt. 14-12-1992.

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Drugs and Cosmetics Rules 1945

83. Renewal.−On application being made for renewal, the licensing authority may cause an inspection to be made and, if satisfied that the condition of the licence and the Rules under the Act are, and will continue to be observed,¹[he shall prepare a report to that effect in respect of those drugs which have been notified by the Central Government under Rule 68-A and forward it along with the application to the Central Licence Approving Authority], and shall issue a certificate of renewal³[under this Part].

3

[83-A. Certificate of renewal of a loan licence.−The certificate of renewal of a loan licence in⁸[Form 28A or Form 28DA] shall be issued in Form 26A or Form 26J respectively.]

4 [83-AA. Duration of loan licence.−An original loan licence in 8 [Form 28A or Form 28DA] or a renewed loan licence in⁸[Form 26A or Form J], unless sooner suspended or cancelled, shall be⁵[valid for a period of five years on and from the date on which] it is granted or renewed:

6 [Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry].]

84. The provisions of this Part shall apply to the manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India. 7 [ 6 [84-A. Provision for appeal to the State Government or Central Government by party whose licence has not been granted or renewed.− Any person who is aggrieved by the order passed by the Licensing Authority or the Central Licence Approving Authority, as the case may be, refusing to²[grant or renew a licence under this Part], may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, and the State Government or the Central Government may, after such enquiry into the matter,] as is considered necessary and after giving the said person an opportunity for representing his views, may pass such order in relation thereto as it thinks fit.]

1. Ins. by G.S.R. 923 (E), dt. 14-12-1992.

2 . Subs. by G.S.R. 119 (E), dt. 11-3-1996..

3. Ins. by F1-16/57-B, dt. 15-6-1957.

4. Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.

5. Subs. by G.S.R. 601 (E), dt. 24-8-2001.

6. Subs. by S.O. 2139, dt. 12-8-1972.

7. Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993.

8. Subs. by G.S.R. 574 (E), dt. 17-5-2012.

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Drugs and Cosmetics Rules 1945

6 [84AA. Additional information to be furnished by an applicant for licence or a licensee to the licensing authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]

1 [84B. Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates. No person shall manufacture for sale cyclamates and preparations containing cyclamates.]

2 [85. Cancellation and suspension of licences. (1) The Central Licence Approving Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part, or suspend it for such period as he thinks fit either wholly or in respect of any of the drugs to which it relates³[or direct the licensee to stop manufacture, sale or distribution of the said drugs and⁴[thereupon order the destruction of drugs and] the stock thereof in the presence of an Inspector], if in his opinion, the licensee has failed to comply with any of the conditions of the licencee or with any provisions of the Act or rules made thereunder.

(2) The Licensing Authority may, for such licences granted or renewed by him, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates,³[or direct the licensee to stop manufacture, sale or distribution of the said drugs and⁴[thereupon order the destruction of drugs and] the stock thereof in the presence of an Inspector] if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules made thereunder.]

5 [(3) A licensee whose licence has been suspended or cancelled by the Central Licence Approving Authority or Licensing Authority under sub-rule (1) or sub-rule (2), as the case may be, may within ninety days of the receipt of a copy of the order by him prefer an appeal to the Central Government or the State Government, as the case may be, and the Central Government or the State Government may after giving the licensee an opportunity of being heard, confirm, reverse or modify such order.]

1. Ins. by S.O.2358, dt. 26-8-1972.

2. Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993.

3 . Ins. by G.S.R. 20 (E), dt. 11-1-1996.

4 . Ins. by (Corrigenda) G.S.R. 514 (E), dated 5.11.1996.

5. Ins. by 615 (E), dt. 9-8-1994 as corrected by G.S.R. 55 (E), dt. 7-2-1995.

6. Ins. by S.O. 2139, dt. 5-6-1972.

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1 [PART VIIA

2 [MANUFACTURE FOR SALE OR FOR DISTRIBUTION]

OF HOMOEOPATHIC MEDICINES

85A . Manufacture on more than one set of premises. If Homoeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.

85B. Application for licence to manufacture Homoeopathic medicines. (1) Application for grant or renewal of²[licence to manufacture for sale or for distribution] of Homoeopathic medicines shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) and shall be made in Form 24-C. 3 [(2) The application in Form 24-C shall be accompanied-

(a) by a fee of⁴[rupees two hundred] for the manufacture of Homoeopathic mother tinctures and potentised preparations and an inspection fee of⁴[rupees one hundred] for the first inspection or⁴[rupees fifty] in case of inspection for renewal of licence;

(b) by a fee of⁴[rupees two hundred] for the manufacture of Homoeopathic potentised preparations only, and an inspection fee of⁴[rupees one hundred] for the first inspection or⁴[rupees fifty] in case of inspection for renewal of licence;

(c) by a fee of⁴[rupees two hundred] for the manufacture of potentised preparations from back potencies by pharmacies which are already licensed to sell Homoeopathic medicines by retail and an inspection fee of⁴[rupees one hundred] for the first inspection or⁴[rupees fifty] in case of inspection for renewal of licence.

1. Ins. under G.S.R. 1185 (E), dt. 18-8-1964.

2. Sub. by G.S.R. 788 (E), dt. 10-10-1985.

3. Sub. by G.S.R. 245, dt. 11-2-1976.

4 . Subs. by G.S.R. 601 (E), dt. 24 -8-2001.

115

Drugs and Cosmetics Rules 1945 1 [(3) If a person applies for renewal of a licence after its expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be^_ (a)²[rupees two hundred] plus an additional fee at the rate of²[rupees one hundred] per month or part thereof and an inspection fee of²[rupees fifty] for the manufacture of Homoeopathic mother tinctures and potentised preparations;

4 [(b) 2 [rupees two hundred] plus an additional fee at the rate of 2 [rupees one hundred] per month or part thereof and an inspection fee of²[rupees fifty] for the manufacture of Homoeopathic potentised preparations only;] (c)²[rupees two hundred] plus an additional fee at the rate of²[rupees one hundred] per month or part thereof and an inspection fee of²[rupees fifty] for the manufacture of Homoeopathic mother tinctures and potentised preparations from back potencies by pharmacies who are already licensed to sell Homoeopathic medicines by retail.]

(4) A fee of²[rupees fifty] shall be paid for a duplicate copy of the licence for the manufacture of Homoeopathic mother tinctures and potentised preparations issued under sub-rule (1) if the original is defaced, damaged or lost, while the fee to be paid for such a duplicate copy of the licence for the manufacture of Homoeopathic potentised preparations only shall be²[rupees fifty].

3 [(5) Applications by licensee to manufacture additional items of Homoeopathic medicines shall be made to the Licensing Authority and such applications shall be accompanied by a fee of²[rupees fifty] for each additional item.]

85C. Application to manufacture 'New Homoeopathic medicines.' Subject to the other provisions of these Rules

(1) no 'New Homoeopathic medicine' shall be manufactured unless it is previously approved by the Licensing Authority mentioned in Rule 21;

(2) the manufacturer of 'New Homoeopathic medicine', when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.

1. Subs. by G.S.R. 245, dt. 3-2-1976.

2 . Subs. by G.S.R. 601 (E), dt. 2 4-8-2 001.

3. Ins. by G.S.R. 13 (E), dt. 7-1-1983.

4. Subs. by G.S.R. 779 (E), dt. 18-7-1980.

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Drugs and Cosmetics Rules 1945

(3) While applying for a licence to manufacture a 'New Homoeopathic medicine' an applicant shall produce along with his application evidence that the 'New Homoeopathic medicine' for the manufacture of which application is made has already been approved.

Explanation.−The term 'New Homoeopathic medicine' in this rule shall have the same meaning as in rule 30AA.

1 [85D. Form of licence to manufacture Homoeopathic medicines.—Licence for manufacture of Homoeopathic medicines is a licence to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail and shall be granted in Form 25C.]

85E. Conditions for the grant or renewal of a licence in Form 25C−Before a licence in Form 25C is granted or renewed the following conditions shall be complied with by the applicant:—

(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee²[and who is—

(a) a graduate in Science with Chemistry as one of the subjects with three years' experience in manufacture of Homoeopathic Medicines; or

(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or

(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines:

Provided that the persons who are already in employment with five years' experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.]

3 [(2) The factory premises shall comply with the requirements and conditions specified in Schedule M-I:

1. Amended by F.1-59/68-D (SO 4816), dt. 19-11-1969.

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Drugs and Cosmetics Rules 1945 Provided that where the Licensing Authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.]

(3) The applicant for manufacture of Homoeopathic mother tinctures shall either (i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or (ii) make arrangements with some institution approved by the Licensing Authority²[under Part XV(A) of these rules] for such tests, wherever possible, to be regularly carried out on his behalf by that institution.

(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes.

(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine.

(6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him:

1 [Provided that in case potentised preparations are made in a Pharmacy holding licence in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the Licensing Authority that the products manufactured by it, conform to the claims made on the label.]

3 [85-EA. Inspection before grant or renewal of licence.-- Before a licence under this Part is granted or renewed in Form 25C or Form 26C, the Licensing Authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted, to be inspected by one or more Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Part I of Schedule M read with the requirements of maintenance of records as laid down in Schedule U.

1. Amended by F.1-59/68-D (SO 4816), dt. 19-11-1969.

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85EB. Report by Inspector.-The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection along with his or their recommendations after completion of his or their inspection to the Licensing Authority.

85EC. Grant or refusal of licence.- (1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that conditions of the licence and the rules under the Act shall be observed, he shall grant or renew a licence in Form 25C or Form 26C.

(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of inspection report.]

85ED. Further application after rejection. .-If within a period of six months from the rejection of an application for a licence, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection fee of¹[rupees two hundred and fifty], the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of licence have been complied with, issue a licence in Form 25C or Form 26C.

85EE. Appeal to the State Government.-Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a licence under this Part may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.]

85F. Duration of licence.-An original licence or a renewed licence unless it is sooner suspended or cancelled shall be¹[valid for a period of five years on and from the date on which] it is granted or renewed:

2 [Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months of its expiry.]

85G. Certificate of renewal.-The certificate of renewal of a licence in Form 25-C shall be issued in Form 26-C.

1 . Subs. by G.S.R. 601 (E), dt. 24-8-2001 .

2. Subs. by S.O. 2139, dt. 12-8-1972.

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85H. Conditions of licence.-A licence in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely :

(a) the licensee shall provide and maintain staff and premises as specified in Rule 85-E;

(b) the licensee shall allow an¹[Inspector appointed under the Act] to enter, with or without prior notice, any premises where the manufacture of a Homoeopathic medicine in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured Homoeopathic medicines;

(c) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules made thereunder have been observed;

2 [(d) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed;]

(e) the licensee shall comply with the following conditions in respect of mother tinctures manufactured by him^_

(i) the crude drug used in the manufacture of the mother tincture shall be identified and records of such identification shall be kept³[for a period of five years];

(ii) the total solids in the mother tincture shall be determined and records of such tests shall be kept³[for a period of five years];

(iii) the alcohol content in the mother tincture shall be determined and records of the same shall be maintained³[for a period of five years];

(iv) the containers of mother tinctures shall preferably be of glass and shall be clean and free from any sort of impurities or adhering matter. The glass shall be neutral as far as possible;

(v) in the process of manufacture of mother tinctures hygienic conditions shall be scrupulously observed by the licensee. Storage and handling conditions shall also be properly observed by the licensee according to Homoeopathic principles;

1. Amended by G. S. R. 444, dt. 28-4-1973.

2. Amended by F-1-14/ 68-D, dt. 26-10-1968.

3 . Ins. by G.S.R. 13 (E), dt. 7-1-1983 .

120

Drugs and Cosmetics Rules 1945 1 [(ea) no colour shall be added to any Homoeopathic medicines :

Provided that caramel may be added to combination of Homoeopathic preparations with syrup base;]

(f) records shall be maintained of Homoeopathic medicines containing alcohol and the quantities sold together with names and addresses of parties to whom sold.²[Such records shall be maintained for a period of five years.] 3 [85HH. Additional information to be furnished by an applicant for the licence or a licensee to the Licensing Authority.-The applicant for the grant of licence or any other person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation in rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matters which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]

85-I. Cancellation and suspension of licences.- (1) The Licensing Autority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder.

4 [(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]

PART VIII

MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS

86. Conditions relating to manufacture for examination, test or analysis.-The provisions of Section 18 of the Act shall not apply to the manufacture of any drug in small quantities for the purpose of examination, test or analysis if the conditions prescribed in this Part are fulfilled.

87. Labelling.-Any drug manufactured for the purpose of examination, test or analysis shall be kept in containers bearing labels indicating the purpose for which it has been manufactured.

88. Labelling of drugs supplied to other persons.-If any drug manufactured for the purpose of examination, test or analysis is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the substance if known, or if not known a reference which will enable the substance to be identified and the purpose for which it has been manufactured.

1. Ins. by G.S.R. 680 (E), dt. 5-12-1980.

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89. Licence.-If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29:

1 [Provided that in the case of a drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the "Licensing Authority"

mentioned in Rule 21, to the effect that there would be no objection to such licence being granted.

90. Form of application.- ²[(1)] An application for a licence in Form 29 shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereafter in this Part referred to as the Licensing Authority) in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured.

4 [(2) Every application in Form 29 shall be accompanied by a fee of 3 [rupees two hundred fifty].

91. Duration of licence.-A licence in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time.

92. Conditions of licence. −A licence in Form 29 shall be subject to the following conditions

(a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence;

(b) the licensee shall allow any³[inspector appointed under the Act] to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted;

(c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied;

(d) the licensee shall comply with such further requirements, if any, applicable to the holders of licences in Form 29 as may be specified in any rules subsequently made under the Act and of which the Licensing Authority has given him not less than one month's notice;

(e) the licensee shall maintain an Inspection Book to enable an Inspector to record his impressions and defects noticed.

93. Cancellation of licences.-

(1) The Licensing Authority may after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part, either wholly or in respect of some of the substances to which it relates, if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provision of the Act or Rules thereunder

1. Ins. under F. 1-19/59-D (SO 1449), dt. 13-6-1961.

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Drugs and Cosmetics Rules 1945 1 [(2) A licensee whose licence has been suspended or cancelled may appeal to the State Government within three months of the date of the order.]

PART IX

LABELLING AND PACKING OF DRUGS OTHER THAN

HOMOEOPATHIC MEDICINES

94. Exemption of certain drugs from certain provisions of this Part.— (1) Labels on packages or containers of drugs for export shall be adapted to meet the specific requirements of the law of the country to which the drug is to be exported but the following particulars shall appear in a conspicuous position on the innermost container in which the drug is packed and every other covering in which that container is packed:

(a) name of the drug;

(b) the name, address of the manufacturer and the number of the licence under which the drug has been manufactured;

(c) batch or lot number;

(d) date of expiry, if any:

2 [Provided that where a drug, not classified under Schedule F, Schedule F(1) and Schedule X,⁵[or blood products defined under rule 122EA] is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in Rule 21.]

⁴[Provided further that where a drug classified as Narcotic Drug or Psychotropic Substance is to be exported under a code number, the same may be permitted by the said licensing authority on the following conditions, namely:-

(i) Each consignment of export shall be accompanied with requisite import license from the importing country;

(ii) The applicant shall obtain a no objection certificate from the Drugs Controller, India for manufacture of such formulations to be exported with code number against each export order along with certificate from the regulatory authority of the importing country controlling Narotic Drugs and Psychotropic Substances that they do not have any objection for the import of the drug with code number;

(iii) The State Licensing Authority shall issue the manufacturing license for these formulations on each export order on the basis of a No Objection Certificate from Drugs Controller, India;

(iv) A no objection certificate shall be obtained from the drugs Controller, India for export of each consignment; and

(v) A no objection certificate shall be obtained from the Narcotic Commissioner of India, Gwalior for export of each consignment of the drug.]

3 [(2) The provisions of Rules 96 to 101 inclusive, shall not apply to a medicine made up ready for treatment, whether after or without dilution, which is supplied on the prescription of a registered practitioner provided that:

(i) the medicine is labelled with the following particulars : -

(a) the name and address of the supplier;

(b) the name of the patient and the quantity of the medicine;

(c) the number representing serial number of the entry in the prescription register;

1. Subs. by F.1-10/68-D (S.O 2482), dt. 17-6-1969.

2. Ins. by G.S.R. 676 (E), dt. 2-6-1988.

3. Subs. by F.1-19/59-D, dt. 13-6-1961.

4 . Ins. by G.S.R. 592 (E), dt. 13-8-2008.

5. Subs. by 592 (E), dt. 13-8-2008.

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(d) the dose, if the medicine is for internal use; 1 [(e) the words "FOR EXTERNEL USE ONLY" shall be printed on the label if the medicine is for external application].

(ii) Condition (3) of the conditions in Rule 65 is satisfied.]

95. Prohibition of sale or distribution unless labelled.—Subject to the other provisions of these Rules, no person shall sell or distribute any drug (including a patent or proprietary medicine) unless it is labelled in accordance with these Rules. 2 [96. Manner of Labelling .— (1) Subject to the other provisions of these Rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely :—

(i) the name of the drug− 3 [(A) for this purpose, the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name and shall be]—

(a) for drugs included in the Schedule F or Schedule F (1), the name given therein;

(b) for drugs included in the Indian Pharmacopoeia or the official pharmacopoeias and official compendia of drug standards prescribed in Rule 124, the name or synonym specified in the respective official pharmacopoeias and official compendia of drug standards followed by the letters 'I.P., or, as the case may be, by the recognized abbreviations of the respective official pharmacopoeias and official compendia of drug standards;

(c) for drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters 'N.F.I.';

(d) for other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international non-proprietary name is not published, the name descriptive of the true nature or origin of the substance;

4 [* * * * *]

(ii) A correct statement of the net content in terms of weight, measure, volume, number of units of contents, number of units of activity, as the case may be, and the weight, measure and volume shall be expressed in Metric system.

1. Subs. by G.S.R. 462 (E), dt. 22-6-1982.

2 Amended under G.S.R.19, dt. 15-12-1977.

3. Subs. by G.S.R. 27(E), dt. 17-1-1981.

4. Sub-clause (B) omitted by G.S.R. 94 (E), dt. 8-2-2000. Earlier ins. by G.S.R. 27 (F), dt.-1-1981.

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(iii) The content of active ingredients− This shall be expressed−

(a) for oral liquid preparations in terms of the content per single dose, being indicated in 5 millilitres¹[** *]:

Provided that where the dose is below 5 millilitres the contents of active ingredients may be expressed in terms of 1 millilitre;²[or fraction thereof:]

3 [Provided further that where the single dose is more than 5 millilitres, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority;]

(b) for liquid parenteral preparations ready for administration in terms of 1 millilitre or percentage by volume or per dose in the case of single dose container :

Provided that if the preparation is contained in an ampoule it will be enough if the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale;

(c) for drugs in solid form intended for parenteral administration, in terms of units or weight per milligram or gram;

(d) for tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be;

(e) for other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or millilitre, as the case may be:

Provided that clause (iii) shall not apply to the pharmacopoeial preparations where the composition of such preparation is specified in the respective pharmacopoeia and to a preparation included in the National Formulary of India. (iv)⁴[The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured:] Provided that if the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the manufacturer and his principal place of 5 [manufacture] is shown.

(v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words 'Batch No.' or 'B. No.' or 'Batch' or 'Lot No.' or 'Lot'.

NOTES

(1) In the case of drugs manufactured by a continuous process, like manufacture of magnesium sulphate, pharmaceutical chemicals etc., the production resulting in one homogenous mix of the finished products shall be considered as one "Batch".

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Drugs and Cosmetics Rules 1945

(2) In the case of powders, liquid orals, ointments etc., one "Batch Number"

shall be assigned to all the containers filled from one homogenous bulk.

(3) In the case of tablets, capsules, lozenges, troches, etc., one "Batch Number" shall be assigned to the products manufactured from one homogenous mix ready for compression or filling.

(4) In the case of parenteral preparations sterilized by steam under pressure, one "Batch Number" shall be assigned to all containers filled from one homogenous bulk solution and sterilized in one sterilizer load.

(5) In the case of containers of parenteral preparations filled from one homogenous bulk solution and sterilized in more than one sterilizer load, the

"Batch Number" assigned to the containers in the different sterilizer loads shall be the same "Batch Number" as is assigned to the homogenous bulk solution, provided the samples taken from all the sterilizer loads pass the sterility test, and are kept separate from one another until the report of the sterility test is available. Explanation.— For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous bulk solution should be taken.

(6) In the case of parenteral and other sterile products filled aseptically, a

"Batch Number" shall be assigned to all containers filled from one homogenous mix during one filling operation, the filling operation being completed in a period of not more than a day and during which no schedule change in the filling assembly is made.

When containers are filled from one homogenous mix, in a number of filling operations, the "Batch Number" assigned to the containers filled in individual filling operations shall be the same "Batch Number" as is assigned to the homogenous mix, provided the samples taken from all the different filling operations pass the sterility tests, and are kept separate from one another until the report of the sterility test is available.

Explanation.-For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous mix should be taken.

(7) In the case of medicinal gases produced by a continuous process of operation a week's production from one tank load shall be considered as a Batch.

(vi) Every drug manufactured in India shall bear on its label the number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words "Manufcaturing Licence Number" or "Mfg. Lic. No." or "M.L.".

(vii) Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of manufacture, and the date of expiry of potency, and the period between the date of manufacture

126

Drugs and Cosmetics Rules 1945 and the date of expiry shall not exceed that laid down in the said Schedule 1 [under the conditions of storage specified therein. 2 [Drugs and their preparations not included in Schedule P], shall bear on their labels the date of their manufacture and also the date of their expiry which shall not exceed sixty months from the date of manufacture:]

Provided that this period may be extended by the Licensing Authority specified in clause (b) of Rule 21 in respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension. 7 [(viii) Drugs specified in Schedule C(I) and their preparations including combinations in other drugs shall bear on their labels (a) the date of manufacture, and (b) date of expiry of potency fixed by the manufacturer:

3 [ 4 [Provided that drugs in bulk form included in Schedule C(I) which are not ready for use and not included in Schedule P need not bear on the label the date of expiry of potency:]

Provided further that no reference shall be made to any other licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter or advertisement enclosed therewith].

(ix) Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words 'Physician's Sample—Not to be sold' which shall be overprinted.

5 [(x) If any preparation contains not less than 3 per cent by volume of alcohol the quantity of alcohol shall be stated in terms of the average percentage by volume of absolute alcohol in the finished products.] 6 [(xi) In addition to the other particulars which are required to be printed or written under these Rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than 1mm in width and without disturbing the other conditions printed on the label under these rules, namely: —

1. Subs. by G.S.R. 17 (E), dt. 7-1-1986.

2. Subs. by G.S.R. 285 (E), dt. 16-7-1996.

3. Subs. by G.S.R. 487(E), dt. 2-7-1984.

4. Subs. by G.S.R. 813 (E), dt. 27-7-1988.

5. Ins. by G.S.R. 462 (E), dt. 22-6-1982.

6. Ins. by G.S.R. 597 (E), dt. 17-6-1992.

7. Subs. by G.S.R. 592 (E), dt. 13-8-2008.

127

Drugs and Cosmetics Rules 1945 Narcotic analgestics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules 'G', 'H', and 'X' whether covered or not in the above list:

Provided that the provisions of this clause shall not apply to: −

(a) preparations intended for animal treatment;

(b) preparations intended for external use;

(c) ophthalmic preparations and ear drops; and

(d) sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use.]

1 [(xii) Drugs and their preparations including combinations with other drugs imported into the country shall also bear on the label, the license number under which the drug is imported, preceded by the words "Import License" and the name and address of the importer.]

(2)(i) The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R.

(ii) The following particulars, in addition to those specified under sub-rule (1) shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container and on every other covering in which the container of a contraceptive, other than a mechanical contraceptive, is packed, namely : −

(a) the date of manufacture;

(b) the date upto which the contraceptive is expected to retain its properties;

(c) the storage conditions necessary for preserving the properties of the contraceptive upto the date indicated in sub-clause (b) :

Provided that for oral contraceptives it shall be sufficient to display on the label of the container the date of manufacture only.

(3)(i) The particulars prescribed in sub-rule (1) shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein.

(ii) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.

(4) Where by any provision of these rules any particulars are required to be displayed on a label on the container, such particulars may, instead of being displayed on a label, be etched, painted or otherwise indelibly marked on the container:

1. Ins. by G.S.R. 592 (E), dt. 13-08-2008.

128

Drugs and Cosmetics Rules 1945 Provided that, except where otherwise provided in these rules, the name of the drug or any distinctive letters intended to refer to the drug shall not be etched, painted or otherwise indelibly marked on any glass container other than ampoules. Explanation.— For the purpose of this rule, the date of expiry shall be in terms of month and year and it shall mean that the drug is recommended till the last day of the month. The date of expiry shall be preceded by the words 'Expiry date'.]

97. Labelling of medicines.— ¹[(1) The container of a medicine for internal use shall—

(a) if it contains a substance specified in Schedule G, be labelled with the words "Caution: it is dangerous to take this preparation except under medical supervision" - conspicuously printed and surrounded by a line within which there shall be no other words;

(b) if it contains a substance specified in Schedule H, be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:

'Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only',

(c) if it contains a substance specified in Schedule H, and comes within the purview of the²[Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] be labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:

'Schedule H drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only';

(d) If it contains a substance specified in Schedule X, be labelled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label and be also labelled with the following words : - 'Schedule X drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only'.

4 [(e) if it contains a drug substance specified in Schedule H1, the drug formulation shall be labeled with the symbol Rx which shall be in red conspicuously displsyed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border:

"SCHEDULE H1 DRUG - WARNING. - It is dangerous to take this preparation except in accordance with the medical advice.

- Not to be sold by retail without the prescription of a Registered Medical Practitioner.]

(2) The container of an embrocation, liniment, lotion,³[ointment, antiseptic cream,] liquid antiseptic or other liquid medicine for external application shall be labelled with the words:

"FOR EXTERNAL USE ONLY".

129

Drugs and Cosmetics Rules 1945 1 [(3) The container of a medicine made up ready only for treatment of an animal shall be labelled conspicuously with the words 'Not for human use; for animal treatment only' and shall bear a symbol depicting the head of a domestic animal.] 2 [* * * * *]

10 [(3A) The container of a medicine for treatment of food producing animals shall be labeled with the withdrawal period of the drug for the species on which it is intended to be used:

Provided that if the specific withdrawal period has not been validated, the withdrawal period shall not be less than seven days for eggs or milk, twenty eight days for meat from poultry and mammals including fat and offal, five hundred degree days for fish meat.

Explanation:- For the purpose of this Rule, the withdrawal period is the period of interval between the last administration of a veterinary medicine to animals under the normal conditions of use and the production of food stuff from such animals to ensure that food stuffs do not contain residues in quantities in excess of the maximum residue limits laid down.]

3 [(4)] The container of a medicine prepared for treatment of human ailments shall if the medicine contains industrial methylated spirit, indicate this fact on the label and be labelled with the words :

"For External Use only".

4 [(5) Substances specified in Schedule X in bulk form shall bear a label wherein the symbol as specified in sub-Rule (1) shall be given conspicuously in red letters.] 5 [* * * * *]

6 [102. Non-Sterile Surgical Ligature and Suture.- Every container of, and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words "Non-sterile surgical ligature (suture) - not to be used for operations upon the human body unless efficiently sterilized".]

103. ⁷[* * * * *]

(2) The name and address of the manufacturer shall be printed on the label of the container of a patent or proprietary medicine.

8 [(3) The true formula or list of the ingredients shall be printed or written in indelible ink on the outer label of every package containing patent or proprietary medicine.]

9 [104 Use of letter I.P. etc.--The letters 'I.P'. and recognized abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these Rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognized under the Rules.]

1. Subs. by notification No. F.1-6/62-D(S.O.2889),, dt. 2.7.1969.

2. Subs. (4) omitted by G.S.R. 462 (E), dt. 22-1-1982.

3. Sub-rule (5) re-numbered as sub-Rule (4), by G.S.R. 462 (E), dt. 22-6-1982.

4. Ins. by G.S.R. 462 (E), dt. 22-6-1982.

5. Rules 98, 99,100 and 101 omitted, by G.S.R. 462 (E), dt. 22-6-1982.

6. Sub. by F. No. F1-3/51-DS, dt. 15.10.1954.

130

Drugs and Cosmetics Rules 1945 1 [104A. Prohibition against altering inscriptions on containers, labels or wrappers of drug. -No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug:

Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the Licensing Authority.]

2 [105. Packing of drugs.-(1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P1 to these rules.

(2) The pack sizes of drugs not covered by Schedule P-1 shall be as given below: - Unless specified otherwise in Schedule P-1,

(i) The pack sizes for Tablets/Capsules shall be- Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack size of Tablets/Capsules shall contain multiples of 5.

(ii) The pack sizes for liquid Oral preparations shall be 30 ml (paediatric only)/60 ml/100 ml/200 ml/450 ml.

(iii) The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.

(iv) The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml.

(v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm:

Provided that the provisions of the pack sizes covered under this rule shall not apply to: -

1. Pack sizes or dosage forms not covered by the foregoing provisions of this rule.

2. The imported formulations in finished form.

3. Preparations intended for Veterinary use.

4 Preparations intended for Export.

5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral forms, Unit dose (including applicaps).

6. Pack sizes of dosage forms meant for retail sale to Hospitals, Registered Medical Practitioners, Nursing Homes.

7. Physician's Samples.

8. Pack sizes of large volume Intravenous Fluids:

4 [Provided further that] pack sizes of any of the new drug as and when approved by the Licensing Authority appointed under Rule 21 and if not covered under this rule, shall be examined for the purpose of approval with specific justification by the said Licensing Authority:

3 [ 4 [Provided also that] Oxytocin injection meant for sale shall be in single unit blister pack only:]

5 [Provided also that Diclofenac injection for human use shall be in single unit dose pack only.]

1. Ins. by G.S.R. 1242 (E), dt. 17-9-1979.

2. Ins. by G.S.R. 796 (E), dt. 1-10-1992.

3. Sub. by G.S.R. 242 (E), dt. 3-4-2001.

4. Sub. by G.S.R. 558 (E), dt. 17-7-2015.

5. Ins. by G.S.R. 558 (E), dt. 17-7-2015.

131

Drugs and Cosmetics Rules 1945 1 [105A. Packings of drugs specified in Schedule X.- The drugs specified in Schedule X shall be marketed in packings not exceeding-

(i) 100 unit doses in the case of tablets/capsules;

(ii) 300 ml in the case of oral liquid preparations; and

(iii) 5 ml in the case of injections:

Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that-

(i) such supplies are made by the manufacturers or distributors direct to the hospital/dispensaries; and

(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.]

2 [106. Diseases which a drug may not purport to prevent or cure.—(1) No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments specified in Schedule J.

(2) No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women. 3 [* * * *]

4 [PART IXA

LABELLING AND PACKINGOF HOMOEOPATHIC MEDICINES

106-A. Manner of labelling of Homoeopathic medicines.—(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed—

(i) The words 'Homoeopathic medicine',

(ii) The name of the medicine— 5 [(a) For drugs specified in the Homoeopathic Pharmacopoeias of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.]

(b) For other drugs, the name descriptive of the true nature of the drugs.

1. Ins. by G.S.R. 462 (E), dt. 22-6-1982.

2. Sub. by notification F. 1-16/52-DC (SO 2122), dt. 22-6-1954.

3. Omitted by G.S.R. 462(E), dt. 22.6.1982.

4. Ins. by G.S.R. 1185 (E), dt. 18.8.1964.

5. Subs. by G.S.R. 680 (E), dt. 5-12-1980.

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(iii) The potency of the Homoeopathic medicine—For this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems. 1 [(iiiA) In case of Homoeopathic medicine containing two or more ingredients the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label.]

2 [(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer—the name and address of the seller:]

5 [Provided that where such medicines are imported, the name and address of the importer shall also be mentioned on the label.]

(v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label:

3 [Provided that in case the total quantity of the pharmacopoeial homoeopathic medicine in the container is 30 millilitres or less, it will not be necessary to state the content of alcohol on the label.]

(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars: −

(i) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the words "Batch No." or "Batch" or "Lot Number" or "Lot No." or "Lot" or any distinguishing prefix.

(ii) Manufacturing licence number, the number being preceded by the words

"Manufacturing Licence Number" or "Mfg. Lic. No." or "M.L.".

4 [Explanation.−This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.

(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label.]

1. Subs. by G.S.R. 466 (E), dt. 17-5-1994.

2. Sub. by notification F.1-59/68-D, dt. 19-11-1969.

3. Subs. by G.S.R. 108 (E), dt. 22-2-1994.

4. Ins. by S.O. 2139, dt. 12-8-1972.

5. Ins. by G.S.R. 263 (E), dt. 20-4-2009.

133

Drugs and Cosmetics Rules 1945 1 [106-B. Prohibition of quantity and percentage.-No Homoeopathic medicine containing more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres.]

PART X

SPECIAL PROVISIONS RELATING TOBIOLOGICAL

AND OTHER SPECIAL PRODUCTS

2 [107. Name of substance.—If any substance specified in Schedule C is advertised or sold as a proprietary medicine or is contained in a medicine so advertised or sold, the proper name of the substance shall appear on the label in the manner prescribed in this Part. 3 [Explanation.−For the purpose of this rule the expression "proper name" means the proper name stated in Schedule F or if no such name is stated, the name descriptive of the true nature and origin of the substance:

Provided that in the case of veterinary biological product the expression "proper name"

means the proper name stated in Schedule F (1) or if no such name is stated, the name or synonym given in the current edition for the time being of the⁴[British Pharmacopoea (Veterinary)] , or, if no such name is stated either in Schedule F (1) or the⁴[British Pharmacopoea (Veterinary)], the name descriptive of the true nature and origin of the substance approved by the Licensing Authority.

108. Container.—⁵[(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilized container made of glass or any other suitable material approved for the purpose by the Licensing Authority appointed under rule 21, in such manner as may, in the opinion of the Licensing Authority, suffice to preclude the access of bacteria:

Provided that it shall not be necessary to use a previously sterilized container if the filled and sealed container is to be sterilized after the sealing and such sterilizing procedure would render the product sterile. However, the Licensing Authority may, for any special reasons, direct the licensee to pre-sterile such containers.]

(2) When any such substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be withdrawn for use on different occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of any organism which may be accidentally introduced in the process of removing a portion of the contents of the container:

6 [Provided that nothing in this sub-rule shall apply to a penicillin suspension in oil and wax.]

1. Ins. by G.S.R. 108 (E), dt. 22-2-1994.

2. Subs. by F. 1-5/47-D (SRO 2889), dt. 25-11-1949.

3. Subs. by F. 1-6/62-D, dt. 2-7-1969.

4 . Subs. by G.S.R.64 7 (E), dt. 28-10-1998.

5 . Subs. by G.S.R. 245 , dt. 21-2-1976.

6. Ins. by SO 115, dt. 04-1-1961.

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Drugs and Cosmetics Rules 1945 1 [(3) The container shall comply with such further requirements, if any, as are specified in Schedule F or Schedule F (1) as the case may be, in that behalf.

(4) The Licensing Authority may in the case of any particular preparation of any such substance dispense with any of the requirements of this Rule or Schedule F or Schedule F (1) as the case may be, and may make such additional requirements, as having regard to the nature of the preparation, they may deem necessary.]

2 [109. Labelling.-(1) The following particulars and such further particulars, if any, as are specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink on the label of every phial, ampoule or other container of a substance specified in Schedule C and on every other covering in which such phial, ampoule or container is packed—

(a) where a drug is imported, the number of licence under which it is imported, preceded by the words 'Import Licence':

Provided that no reference shall be made to any other import licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter of advertisement enclosed therein;

(b) where a test for potency in units is required by these rules, a statement of the potency in units defined in terms of relation to the standard preparation specified in Schedule F or F (1), as the case may be :

Provided that this clause shall not apply in the case of vaccine lymph;

(c) where a test for potency or maximum toxicity is required the date upto which the substance if kept under suitable conditions may be expected to retain a potency not less than stated on the label of the container or not to acquire a toxicity greater than that permitted by the test, as the case may be. The date of expiry shall be in terms of month and year and it shall mean that the drug is recommended for use till the last day of the month. The date of expiry shall be preceded by the words 'Expiry date' :

Provided that nothing in these rules shall be deemed to require the labelling of any transparent cover or any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.

(2) The particulars prescribed in clause (a) of the preceding sub-rule shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein.

1. Subs. by F.1-6/62-D (SO 2889), dt. 2-7-1969.

2. Subs. by G.S.R.19, dt. 15-12-1977.

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(3) The following particulars, and such further particulars, if any, as are specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink either on the label borne by the container of any substance specified in Schedule C or on a label or wrapper affixed to any package in which any such container is issued for sale, namely:-

(a) the date on which the manufacture of the particular batch from which the substance in the container is taken was completed as defined in Schedule F or Schedule F(1), or if there is no definition in Schedule F or Schedule F(1) as hereafter defined in this rule and in the case of vaccine prepared from concentrates, the date of completion of the final products and the bottling for issue;

(b) where an antiseptic substance has been added, the nature and the percentage proportion introduced;

(c) the precaution necessary for preserving the properties of the contents up to the date indicated in clause (c) of sub-rule (1).

(4) For the purpose of clause (a) of sub-rule (3), the date on which the manufacture of a batch is completed shall be—

(a) in cases where a test for potency or toxicity is required by these rules or not being so required, is accepted by the Licensing Authority as sufficient for the purpose of fixing the date of completion of manufacture, the date on which the substance was removed from cold storage after having been kept at a temperature not exceeding 5° C continuously for a period not exceeding two years from the time when the last test was completed,

(b) in cases where no such test is required or accepted−

(i) if the substance is a serum obtained from a living animal, the earliest date on which any material contributing to the batch was removed from the animal;

(ii) if the substance was obtained by the growth of organisms or artificial media, the earliest date on which growth was terminated in any of the material contributing to the batch:

Provided that if a batch of the substance (including all material contributing to this batch) has for a period of not more than three years been kept in cold storage at a temperature not exceeding 5°C continuously from the earliest practicable date after that on which growth was terminated in the material as the case may be, the date of removal from cold storage shall be treated as the date on which the manufacture of the batch is completed;

(c) in all other cases, the date on which the substance is filled in the container. 1 [109-A. Labelling of Medical Devices.- Subject to the other provisions of these rules, the following particulars shall be printed in indelible ink on the label or sticker on the shelf pack of the medical device or on the outer cover of such medical device and on every outer covering in which the medical device is packed, namely:--

(a) proper name of the medical device;

(b) the details necessary for the user to identify the device and its use;

(c) the name of the manufacturer and address of the manufacturing premises where the device has been manufactured;

(d) the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package shall be expressed in metric system; and

(e) the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product:

1. Sub. by G.S.R. 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R. 109 (E), dt. 22-2-1994.

136

Drugs and Cosmetics Rules 1945 Provided that in the case of sterile devices the date of sterilisation may be given as date of the manufacture of the device:

Provided further that the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary;

(f) to provide, wherever required, an indication that the device contains medicinal or biological substance;

(g) to provide, a distinctive batch number or lot number preceded by the word "Lot No."

or "Lot" or "Batch No." or "B. No.";

(h) to indicate, wherever required, any special storage or handling conditions applicable to the device;

(i) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method;

(j) to give, if considered relevant, warnings or precautions for the attention of the user of the medical device;

(k) to label the device, if the device is intended for single use;

(l) to overprint on the label of the container, the words "FOR CLINICAL INVESTIGATION ONLY", if the device is intended for clinical investigation;

(m) to overprint on the label of the device, the words "Physician's Sample—Not to be sold", if a medical device is intended for distribution to the medical professional as a free sample;

(n) to provide, except for imported devices, the manufacturing licence number by preceding the words "Manufacturing Licence Number" or "Mfg. Lic. No." or "M. L";

(o) Devices or In-vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs shall provide the information affixing additional label or sticker on outer shelf pack;

(p) to provide on the label, in case of imported devices, with the approval of the licensing authority mentioned in rule 21, the import licence number, name and address of the importer and address of the actual manufacturing premises, date of manufacture, (if not already printed at the time of import):

Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardisation (ISO) in lieu of text and the device safety is not compromised by a lack of understanding on the part of the user in case the meaning of the symbol is not obvious to the device user.]

1 [109B. Exemption of certain labelling requirements for medical devices for export from India.-- The labels on packages or container of devices for export shall be adopted to meet specific requirements of the law of the country to which the device is to be exported, but the following particulars shall appear in conspicuous manner on the label of the shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed-

(a) name of the Device;

(b) the distinctive batch number or lot number preceded by the word "Lot No." or "Lot"

or "Batch No." or "B.No.";

(c) the date of expiry, if any;

(d) the name and address of the manufacturer and address of actual premises where the device has been manufactured;

(e) the manufacturing Licence No. preceded by the letters "M.L. No" or

"Manufacturing Licence No";

(f) the internationally recognised symbols in lieu of text, wherever required:

1. Ins. by G.S.R. 690 (E), dt. 25-9-2014.

137

Drugs and Cosmetics Rules 1945 Provided that where a device is required by the consignee not to be labeled with the name and address of the manufacturer, the label on the packages or container shall bear a code number as approved by the licensing authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the word "Device" and "manufacturing licence number:

Provided further that where a device is required by the consignee not to be labeled with the code number also, the label on the packages or container shall bear a special code number, as requested by the consignee, and approved by the licensing authority under rule 21.]

1 [109C. Shelf life of the medical devices.-- The shelf life of the medical devices shall not exceed sixty months from the date of manufacture:

Provided that this period may be extended by the licensing authority, in respect of any specified medical device, if satisfactory evidence is produced by the manufacturer to justify such an extension.]

110. Prohibition of sale of substance after prescribed date.-No person shall sell, or exhibit for sale any substance specified in Schedule C after the date recorded on the container, label or wrapper as the date upto which the substance may be expected to retain a potency not less than, or not to acquire a toxicity greater than that required or permitted by the prescribed test as the case may be.

2 [ * * * * *]

1. Ins. by G.S.R. 109 (E), dt. 22-2-1994.

2. Rule 110A omitted by G.S.R. 1242(E), dt. 17.9.1979.

138

Drugs and Cosmetics Rules 1945 1 [111. Standards.-Every substance specified in Schedules C and C (1) intended for sale shall conform with the standards of strength, quality and purity specified in these Rules and in Schedule F or F(1), as the case may be, and the tests for determining such conformity shall be applied to samples taken from the final product after every manufacturing process has been completed.]

2 [112. Tests for strength and quality.-The tests, if any, required for determining the strength and quality of each of the substances specified in Schedules C and C (1) shall be those set out in Schedule F or Schedule F (1)⁴[or as specified, as the case may be].] 3 [* * * * *]

115. Application of tests for sterility.-The tests shall be applied−

(a) to samples taken from each batch of the substance before the operation of filling and sealing the containers in which it is to be issued has commenced except preparations, which after being sealed in the containers are to be sterilized by heat, in a manner satisfactory to the Licensing Authority; and

(b) to the contents of sample containers when ready for issue. 4 [ * * * * *]

119.−(1) If at this examination no growth of micro-organisms is found in any tube, the sample may be treated as having passed the test.

(2) If at the examination a growth of micro-organisms is visible, further samples may be taken and the tests may be repeated on the further samples taken; but no container the contents of which form part of the batch shall be issued until such further samples have passed the test. The process of taking samples from the batch for a test may be repeated twice:

Provided that if the same organism is visible in more than one test the batch shall be treated as not sterile and the material contained in the batch shall not be issued or used as part of a further batch unless and until it has been re-sterilized and has passed the tests.

120.−Notwithstanding anything contained in the last preceding rule, in any case where—

(a) a substance is required in an emergency by a registered medical practitioner, but the licensee has no filled containers in stock; or

1. Amended by F.1-6/62-D (SO 2889), dt. 2-7-1969.

2 Subs. by G.S.R. 663(E), dt. 3.7.1992.

3. Rules 113 and 114 omitted by G.S.R. 663(E),dt. 3.7.1992.

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(b) a substance which in the opinion of the Licensing Authority is so unstable in solution that the delay occasioned by the completing of the sterility test on filled containers would render its issue in active form impossible, the licensee may issue the substance from a batch which has already passed the tests for sterility and freedom from abnormal toxicity, without completing the sterility test on the filled containers, provided that he complies with the following conditions—

(i) the licensee shall before the issue take samples in the required proportion from the containers into which the batch is filled, and after the required inoculation shall examine the tube every day for five days;

(ii) if at any examination any growth is visible in any of the tubes, he shall immediately notify the Licensing Authority;

(iii) he shall keep available for inspection a record of all issues made under this Rule containing such particulars of the circumstances in which the issue is made as the Licensing Authority may require.

1 [121. Test for freedom from abnormal toxicity. -The test for freedom from abnormal toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the case of each batch of the serum tested by the licensee or by an institution approved by the Licensing Authority for the purpose of carrying out the test on its behalf.] 2 [121A. Test for pyrogens-Solution of substances intended for parenteral administration in large volumes (10 ml or more at a time) shall be pyrogen-free and tested for pyrogens. If water or any other aqueous solvent is supplied along with the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.]

122. Substances specified in Schedule C(1). -The following provisions shall apply in the case of a substance specified in Schedule C (1): -

3 [(a) The container shall comply with the requirements, if any, specified in Schedule F or Schedule F (1)⁴[or as specified], as the case may be.]

5 [* * * * *]

(c) The substance shall conform to the standards of strength, quality and purity specified in Schedule F or Schedule F (1)⁴[or as specified], as the case may be and the tests for determining the strength, quality and purity of the substance shall be those specified in Schedule F or Schedule F (1)⁴[or as specified,] as the case may be.

(d) The tests for determining the strength, quality and purity of a substance specified in Schedule F or Schedule F (1)³[or as specified] as the case may be shall be applied to samples taken from the final product after each manufacturing process has been completed.

(e) The substance should be stored in a cool place and away from light.

1. Subs. by G.S.R. 834 (E), dt. 29-12-1999.

2. Subs. by SO 1449, dt. 13-06-1961. Earlier Ins. by F.1-27/56-D, dt. 18-12-1956

3 . Subs. by F.1-6/62-D, dt. 2-7-1969

4. Subs. by G.S.R. 663 (E), dt. 3-7-1992

5. Omitted by G.S.R. 19, dt. 15.12.1977.

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1 [PART X A.

IMPORT OF MANUFACTURE OFNEW DRUG FOR CLINICAL

TRIALS OR MARKETING

122-A. Application for permission to import new drug.- ²[(1) (a) No new drug shall be imported, except under, and in accordance with, the permission granted by the Licensing Authority as defined in clause (b) of rule 21.

(b) An application for the grant of permission to import a new drug shall be made in Form

4 4 to the Licensing Authority, accompanied by a fee of fifty thousand rupees:

Provided that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such application shall be fifteen thousand rupees.

Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by³[Appendix I or Appendix IA or Appendix IB] of Schedule Y, as the case may be].

(2) The importer of a new drug when applying for permission under sub-rule (1), shall submit data as given in³[Appendix I or Appendix IA or Appendix IB] to Schedule Y including the results of local clinical trials carried out in accordance with the guidelines specified in that Schedule and submit the report of such clinical trials in the format given in appendix II to the said Schedule:

Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest, decide to grant such permission on the basis of data available from other countries:

Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules. 2 [(3) The Licensing Authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue an import permission in Form 45 and/or Form 45- A, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.]

122-B. Application for approval to manufacture new drug ⁴[***].- ²[(1)(a) No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in clause (b) of rule 21.

1. Ins. by G.S.R. 944 (E), dt. 21-9-1988.

2 . Subs. by G.S.R. 900 (E), dt. 12 .12 .2 001.

3. Subs. by G.S.R. 918 (E), dt. 30.11.2005.

4. Omitted by G.S.R. 26 (E), dt. 19.01.2006.

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(b) An application for the grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of Rule 21 and shall be accompanied by a fee of fifty thousand rupees:

Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only.

Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with the new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees:

Provided also that any application received after one year of the grant of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by⁴[Appendix 1 or Appendix 1A or Appendix IB] of Schedule Y, as the case may be.]

(2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the Licensing Authority mentioned in the said sub-rule, shall submit data as given in⁴[Appendix 1 or Appendix 1A or Appendix IB] to Schedule Y including the results of clinical trials carried out in the country in accordance with the guideline specified in Schedule Y and submit the report of such clinical trials in the same format given in Appendix II to the said Schedule.

1 [(2A) The Licensing authority as defined in clause (b) of rule 21 after being satisfied that the drug if approved to be manufactured as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46A, as the case may be, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.]

(3) When applying for approval to manufacture a new drug under sub-rule (1) or its preparations, to the State Licensing Authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved⁵[in the name of the applicant] by the Licensing Authority mentioned in Rule 21:

Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such nature that the⁶[Licensing Authority in Rule 21] may, in public interest, decide to grant such permission on the basis of data available from other countries:

Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carnicogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules. 2 [* * * * *]

3 [122D. Permission to import or manufacture fixed dose combination.- (1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122-E shall be made to the Licensing Authority as defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y.

1. Ins. by G.S.R. 900(E), dt. 12-12-2001.

2. Rules 122-C omitted, by G.S.R. 900(E), dt. 12-12-2001.

3. Subs. by G.S.R. 900(E), dt. 12-12-2001.

4 . Subs. by G.S.R. 918(E), dt. 30-11-2015.

5 . Ins. by G.S.R. 26 (E), dt. 19-01-2006.

6 . Subs. by G.S.R. 26 (E), dt. 19-01-2006 .

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(2) The Licensing Authority after being satisfied that the fixed dose combination if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered.

122DA. Application for permission to conduct clinical trials for New Drug/Investigational New Drug.− (1) No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21.

(2) An application for grant of permission to conduct−

(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y.

(b) exploratory clinical trials (Phase-II) on a new drug shall be made on the basis of data emerging from Phase-I trial, accompanied by a fee of twenty-five thousand rupees;

(c) confirmatory clinical trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees:

Provided that no separate fee shall be required to be paid along with application for import/manufacture of a new drug based on successful completion of phases clinical trials by the applicant:

Provided further that no fee shall be required to be paid along with the application by Central Government or State Government Institutes involved in clinical research for conducting trials for academic or research purposes.

(3) The Licensing Authority after being satisfied with the clinical trials, shall grant permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided on the clinical trials is inadequate, intimate the applicant in writing, within six months from the date of such intimation or such extended period, not exceeding a further period of six months, as the Licensing Authority may, for reasons to be recorded in writing, permit, intimating the conditions which shall be satisfied before permission could be considered. 1 [(4) No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-

(a) the trial is approved by the Ethics Committee; and

(b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.

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1. Ins. by G.S.R. 313(E), dt. 16-03-2016.

(5) The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.]

¹[Explanation:- —For the purposes of these rules,—

(a) "Clinical Trial" means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug;

(b) "Global Clinical Trial" means any clinical trial which is conducted as part of multi- national clinical development of a drug;

(c) "Investigational New Drug" means a new chemical entity or a product having therapeutic indication but which has never been tested earlier on human being;

(d) "New Chemical Entity" means an active substances in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial.] 2 [****]

3 [122-DAB- Compensation in case of injury or death during clinical trial.- 4 [(1) In case of an injury occurring to the subject during the clinical trial, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.]

(2) In case, the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation as per order of the Licensing Authority defined under clause (b) of Rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject. 5 [(2A) In case, there is no permanent injury, the quantum of compensation shall be commensurate with the nature of the non-permanent injury and loss of wages of the subject.]

(3) In the case of clinical trial related death of the subject, his / her nominee(s) would be entitled for financial compensation, as per the order of the Licensing Authority defined under clause (b) of Rule 21 and the financial compensation will be over and above any expenses incurred on the medical management of such subject.

(4) The expenses on medical management and financial compensation in the case of clinical trial injury or death of the trial subject shall be borne by the sponsor of the clinical trial.

(5) Any injury or death of the subject occurring in clinical trial due to following reasons shall be considered as clinical trial related injury or death and the subject or his/her nominees(s), as the case may be, are entitled for financial compensation for such injury or death:

(a) Adverse effect of investigational product(s);

(b) Violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator;

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(c) Failure of investigational product to provide intended therapeutic effect, where, the standard care, though available, was not provided to the subject as per the clinical trial protocol;

(d) Use of placebo in a placebo-controlled trial where, the standard care, though available, was not provided to the subject as per the clinical trial protocol;

(e) Adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol;

(f) For injury to a child in-utero because of the participation of parent in clinical trail;

(g) Any clinical trial procedures involved in the study.

(6) The sponsor, whether a pharmaceutical company or an institution shall give an undertaking along with the application for clinical trail permission to the Licensing Authority defined in clause (b) of Rule 21, to provide compensation in the case of clinical trial related injury or death for which subjects are entitled to compensation.

(7) In case, the sponsor fails to provide medical management for the injury to the subject and / or financial compensation to the trial subject for clinical trial related injury or financial compensation to the subject's nominee(s) in case of clinical trial related death of the subject, the Licensing Authority may after giving an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons thereof, suspend or cancel the clinical trial and / or restrict Sponsor including his representative(s) to conduct any further clinical trials in the country or take any other action deemed fit under the rules.]

1 [122 DAC. Permission to conduct clinical trial:- (1) The Licensing Authority as defined in clause (b) of Rule 21, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respects, issue permission for conduct of clinical trial, subject to the following conditions, namely:-

(a) Clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y annexed to these rules, Good Clinical Practice Guidelines for conduct of clinical trials in India and other applicable regulations;

(b) Approval of the Ethics Committee shall be obtained before initiation of the study;

(c) Clinical trial shall be registered at Clinical Trials Registry of India before enrolling the first patient for the study;

(d) Annual status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Licensing Authority and in case of termination of any clinical trial the detailed reasons for the same shall be communicated to the said Licensing Authority;

(e) Any report of serious adverse event occurring during clinical trial to the subject, after due analysis, shall be forwarded within ten days of its occurrence as per Appendix XI and in compliance with the procedures prescribed in Schedule Y;

(f) In case of an injury or death during the clinical trial to the subject of the clinical trial the applicant shall provide complete medical management and compensation in the case of trial related injury or death in accordance with Rule 122 DAB and the procedures prescribed under Schedule Y, and the details of compensation provided in such cases shall be intimated to the Licensing Authority within thirty days of the receipt of the order of the said authority;

(g) The premises of Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites shall be open to inspection by the officers authorized by the Central Drugs Standard Control Organization, who may be accompanied by an officer of the State Drug Control Authority concerned, to verify compliance to the requirements of Schedule Y, Good Clinical Practices guidelines for conduct of clinical trials in India and other applicable regulations;

1. Ins. by G.S.R. 63 (E), dt. 01-02-2013.

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(h) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites and the investigator shall allow officers authorized by the Central Drug Standard Control Organization, who may be accompanied by an officer of the State Drug Control Authority concerned, to enter with or without prior notice, any premises of sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites to inspect, search and seize any record, data, document, books, investigational drugs etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial;

(2) Notwithstanding the conditions specified in sub-Rule (1), the Licensing Authority, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respect, may also impose such additional conditions for issuance of permission in respect of specific clinical trials, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessments, conduct and treatment of such clinical trial.

(3) If any Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors, Investigators conducting clinical trial and clinical trial sites fail to comply with any of the above conditions, the Licensing Authority, may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons thereof,-

(a) Issue warning letter giving details of deficiency found during the inspection, which might affect the right or well-being of the clinical trial subject or the validity of the study conducted at that site;

(b) Recommend that study may be rejected or discontinued;

(c) Suspend or cancel the clinical trial permission;

(d) Debar the Investigator(s), Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors to conduct any clinical trial in future.

(4) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial Investigators, against whom action as mentioned in sub- Rule (3) has been taken by the Licensing Authority, may, within ninety days of the receipt of the copy of the order of the Licensing Authority prefer an appeal to the Central Government, and the Central Government may, after giving such appellant an opportunity of being heard, confirm, reverse or modify such order.]

122DB. Suspension or cancellation of Permission/Approval.- If the importer or manufacturer under this Part fails to comply with any of the conditions of the permission or approval, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it.

122DC. Appeal.- Any person aggrieved by an order passed by the Licensing Authority under this Part, may within sixty days from the date of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as is considered necessary, pass such order in relation thereto as it thinks fit.

1 [122 DD. Registration of Ethics Committee:- (1) No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of Rule21:

Provided that any Ethics Committee, existing on the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty- five days from the date of commencement of Drugs and Cosmetics (Third Amendment) Rules,

2013.

1. Ins. by G.S.R. 72 (E), dt. 08-02-2013.

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(2) An application for registration of Ethics Committee shall be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule

Y.

(3) The Licensing Authority after being satisfied that the requirements have been complied with, may grant registration to the Ethics Committee subject to such conditions as may be stated therein.

(4) The Ethics Committee shall review and accord its approval to a clinical trial and also carry ongoing review of the trial at appropriate intervals, as specified in Schedule Y, and the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding the rights, safety and well-being of the trial subjects.

(5) In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.

(6) The Ethics Committee shall allow inspectors or officials authorized by the Central Drugs Standard Control Organization to enter its premises to inspect any record, data or any document related to clinical trial and provide adequate replies to any query raised by such inspectors or officials, as the case may be in relation to the conduct of clinical trial.

(7) The registration, unless it is suspended or cancelled, shall be valid for a period of three years from the date of issue:

Provided that if the application for re-registration is received by the Licensing Authority within three months before the expiry, the registration shall continue to be in force until orders are passed by the said authority:

Provided further that the Licensing Authority shall be informed in writing in case of any change in the membership or the constitution of the Ethics Committee takes place.

(8) If the Licensing Authority is not satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and the conditions which must be satisfied before the registration can be granted.

(9) If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.

(10) The Ethics Committee whose registration has been suspended or cancelled by the Licensing Authority, may, within ninety days of the receipt of the copy of the order, prefer an appeal to the Central Government and the Central Government may after giving an opportunity of being heard, confirm, reverse or modify such order.

Explanation:- For the purpose of this Rule an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and will-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards.]

122E. Definition of new drug.- For the purpose of this Part, new drug shall mean and include-

1 [(a) A drug, as defined in the Act including bulk drug substance 2 [or phytopharmaceutical drug] which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:

1. Ins. by G.S.R. 591 (E), dt. 17-8-1999.

2. Ins. by G.S.R. 918 (E), dt. 30-11-2015.

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Drugs and Cosmetics Rules 1945 Provided that the limited use, if any, has been with the permission of the licensing authority.]

(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.

(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of Appendix VI to Schedule Y.) Explanation.- For the purpose of this rule−

1 [(i) all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21;]

(ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval²[***].]

1. Ins. by G.S.R. 45(E), dt. 24.01.2011.

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1 [PART XB

REQUIREMENTS FOR THE COLLECTION, STORAGE,

PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD,

HUMAN BLOOD COMPONENTS BY BLOOD BANKS

ANDMANUFACTURE OF BLOOD PRODUCTS

2 [122EA. Definitions.- (1) In this Part and in the Forms contained in Schedule A and in Part XII-B,³[Part XII-C and Part XIID] of Schedule F, unless there is anything repugnant in the subject or context−

(a) "apheresis" means the process by which blood drawn from a donor, after separating plasma or platelets, or leucocytes, is re-transfused simultaneously into the said donor;

(b) "autologous blood" means the blood drawn from the patient for re-transfusion unto himself later on;

(c) "blood" means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant;

(d) "blood bank" means a place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components;

(e) "blood component" means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor;

(f) "blood product" means a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors;

4 [(fa) "cord blood bank" means a place or organization or unit for carrying out and responsible for operations of collection, processing, testing, banking, selection and release of cord blood units;]

(g) "donor" means a person who voluntarily donates blood after he has been declared fit after a medical examination, for donating blood, on fulfilling the criteria given hereinafter, without accepting in return any consideration in cash or in kind from any source but does not include a professional or a paid donor.

Explanation.- For the purposes of this clause, benefits or incentives like pins, plaques, badges, medals, commendation certificates, time-off from work, membership of blood assurance programme, gifts of little or intrinsic monetary value shall not be construed as consideration;

(h) "leucapheresis" means the process by which the blood drawn from a donor, after leucocyte concentrates have been separarated is re-transfused simultaneously into the said donor;

(i) "plasmapheresis" means the process by which the blood drawn from a donor, after plasma has been separated, is re-transfused during the same sitting into the said donor;

(j) "plateletpheresis" means the process by which the blood drawn from a donor, after platelet concentrates have been separated, is re-transfused simultaneously into the said donor;

(k) "professional donor" means a person who donates blood for a valuable consideration, in cash or kind, from any source, on behalf of the recipient-patient and includes a paid donor or a commercial donor;

(l) "replacement donor" means a donor who is a family friend or a relative of the patient-recipient.]

1. Ins. by G.S.R. 28(E), dt. 22-1-1993.

2. Ins. by G.S.R. 245 (E), dt. 5-04-1999.

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Drugs and Cosmetics Rules 1945 4 [(m) "umbilical cord blood" is the whole blood including Hematopoietic Progenitor Cells collected from placental and or Umbilical cord blood vessels after the umbilical cord have been clamped.]

122-F. Form of application for licence for operation of Blood Bank/processing of whole human blood for components/manufacture of blood products for sale or distribution ⁴[, collection, processing, testing, storage, banking and release of umbilical cord blood stem cells.]- (1) Application for the grant and/or renewal of licence for the operation of a Blood Bank/processing of human blood for components/manufacture of blood products⁴

[ collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] shall be made to the Licensing Authority appointed under Part VII in¹[Form 27- C or⁵[Form 27-E or Form 27-F], as the case may be], and shall be accompanied by³[licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection thereof or for the purpose of renewal of licence]:

Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry the fee payable for the renewal of the licence³[shall be rupees six thousand and inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or a part thereof in addition to the inspection fee]:

5 [Provided further that a licensee holding a license in Form 28-C, Form 28-E or Form 28- F as the case may be, for operation of Blood Bank/ processing of whole human blood for components / manufacture of blood products / collection, processing testing storage, banking and release of umbilical cord blood stem cells shall apply for grant of license under sub Rule

(1) before the expiry of the said license in Form 27-C, Form 27-E or Form 27-F as the case may be and he shall continue to operate the same till the orders on his application are communicated to him.]

2 [***]

(2) A fee of³[rupees one thousand] shall be paid for a duplicate copy of a licence issued under this rule, if the original is defaced, damaged or lost.

(3) Application by a licensee to manufacture additional drugs listed in the application shall be accompanied by a fee of³[rupees three hundred] for each drug listed in the application.

(4) On receipt of the application for the grant or renewal of such licence, the Licensing Authority shall,-

(i) verify the statements made in the application form;

(ii) cause the manufacturing and testing establishment to be inspected in accordance with the provision of rule 122-I; and

(iii) in case the application is for renewal of licence, call for information of past performance of the licensee.

(5) If the Licensing Authority is satisfied that the applicant is in a position to fulfil the requirements laid down in the rules, he shall prepare a report to that effect and forward it 6 [along with the application and the licence (in triplicate) to be granted or renewed, duly completed] to the Central Licence Approving Authority:

Provided that if the Licensing Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence, as the case may be.

(6) If, on receipt of the application and report of the Licensing Authority referred to in sub-rule⁷[(5)] and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, and/or along

1. Subs. by G.S.R. 245(E), dt. 5.4.1999. 4. Ins. by G.S.R. 899 (E), dt. 27-12-2011.

2. Explanation omitted by G.S.R. 733 (E), dt. 21.12.2005 earlier Ins. by G.S.R. 89(E), dt. 14-2-1996.

3 . Subs. by G.S.R. 601(E), dt. 24-8-2001. 5. Subs. by G.S.R. 899 (E), dt. 27-12-2011.

6. Ins. by G.S.R. 89 (E), dt. 14.2.1996.

7 . Corrected by corrigendum G.S.R. 447 (E), dt. 10-06-1993.

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Drugs and Cosmetics Rules 1945 with the Expert in the field concerned if deemed necessary, the Central Licence Approving Authority is satisfied that the applicant is in a position to fulfil the requirements laid down in these rules, he may grant or renew the licence, as the case may be:

Provided that if the Central Licence Approving Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules he may, notwithstanding the report of the Licensing Authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of licence, as the case may be, and shall supply the applicant with a copy of the inspection report.

122G. Form of Licence for the operation of a Blood Bank/processing of whole human blood for components and manufacture of blood products ³[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] and the conditions for the grant or renewal of such licence.−²[(1)] A licence for the operation of a Blood Bank or for processing whole human blood for components and³[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] shall be issued in¹[Form 28C or Form 28E or³[Form 28F or Form 26G or Form26-I or Form 26J, as the case may be, before a license in Form 28C or Form 28E or Form28-F or Form 26G or Form 26-I or Form 26-J], as the case may be,] is granted or renewed the following conditions shall be complied with by the applicant:-

1 [(i) The operation of Blood Bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole time employee and who is Medical Officer, and possessing-

(a) Postgraduate degree in Medicine - M.D (Pathology/Transfusion Medicines); or

(b) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; or

(c) Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components, the degree or diploma being from a University recognized by the Central Government. Explanation.- For the purposes of this condition, the experience in Blood Bank for one year shall not apply in the case of persons who are approved by the Licensing Authority and/or Central Licence Approving Authority prior to the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1999].

(ii) The applicant shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. The space, plant and equipment required for various operation is given in Schedule 'F', Part XIIB and/or XIIC⁴[or XIID].

(iii) The applicant shall provide and maintain adequate technical staff as specified in Schedule F, Part XIIB and/or XIIC⁴[or XIID].

(iv) The applicant shall provide adequate arrangements for storage of whole human blood, human blood components and blood products.

(v) The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of whole human blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.

1. Ins. by GSR 245(E), dt. 5-4-1999.

2. Renumbered as sub-rule (1) by GSR 733(E), dt. 21-12-2005.

3. Subs. by GSR 899(E), dt. 27-12-2011. 4. Ins. by GSR 899(E), dt. 27-12-2011.

151

Drugs and Cosmetics Rules 1945 3 [(2) Application for grant or renewal of a licence for operation of Blood Bank or processing of human blood components shall be made by the Blood Bank run by the Government, Indian Red Cross Society, hospital, charitable trust or voluntary organization approved by a State/ Union Territory Blood Transfusion Council only.

Explanation.- For the purpose of this sub-rule, "renewal" shall include renewal of any licenceissued prior to the commencement of the Drugs and Cosmetics (……..Amendment) Rules,2005.]

122H. Duration of licence.- An original licence in¹[Form 28C or Form 28E⁴[or Form 28F] or a renewed licence in Form 26G or Form 26-I]⁴[or Form 26J] unless sooner suspended or cancelled shall be²[valid for a period of five years on and from the date on which] it is granted or renewed.

122-I. Inspection before grant or renewal of licence for operation of Blood Bank, processing of whole human blood for components and manufacture of blood products.- Before a licence in¹[Form 28C or Form 28E⁴[or Form 28F] is granted or a renewal of licence in form 26G or Form 26-I⁴[or Form 26J] is made, as the case may be,] the Licensing Authority or the Central Licence Approving Authority, as the case may be, shall cause the establishment in which Blood Bank is proposed to be operated/whole human blood for components is processed/ blood products are manufactured to be inspected by one or more Inspectors, appointed under the Act and/or along with the Expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises and appliances/equipments and inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for operation of blood bank/processing of whole human blood for components/manufacture of blood products together with their testing facilities and also enquire into the professional qualification of the expert staff and other technical staff to be employed.

122J. Report by Inspector.-The Inspector or Inspectors shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendation in accordance with the provisions of rule 122-I to the Licensing Authority or to the Central Licence Approving Authority.

122K. Further application after rejection.- If within a period of six months from the rejection of application of a licence the applicant informs the Licensing Authority that the conditions laid down have been satisfied and deposits an inspection²[fee of rupees two hundred and fifty] the Licensing Authority may, if after causing further inspection to be made is satisfied that the conditions for the¹[grant or renewal of a licence have been complied with, shall grant or renew the licence in Form 28C or Form 28E⁴[or Form 28F]:

Provided that in the case of a drug notified by the Central Government under rule 68-A, the application, together with the inspection report and the Form of licence (in triplicate to be granted or renewed), duly completed shall be sent, to the Central Licence Approving Authority, who may approve the same and return it to the Licensing Authority for issue of the licence.]

122L. Delegation of powers by the Central Licence Approving Authority.- The Central Licence Approving Authority may, with the approval of the Central Government, by notification delegate his powers of signing licences and any other power under rules to persons under his control having same qualifications as prescribed for Controlling Authority under rule 50-A, for such areas and for such periods as may be specified.

122M. Provision for appeal to the State Government by a party whose licence has not been granted or renewed.- Any person who is aggrieved by the order passed by the Licensing Authority or Central Licence Approving Authority, as the case may be, may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, after such enquiry into the matter as it considers necessary and after giving the said person an opportunity for representing his view in the matter may pass such order in relation thereto as it thinks fit.

1. Ins. by G.S.R 245(E), dt. 5-4-1999. 3. Ins. by G.S.R 733(E), dt. 21-12-2005.

2. Subs. by G.S.R 601(E), dt. 24-8-2001. 4. Ins. by GSR 899(E), dt. 27-12-2011.

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122-N. Additional information to be furnished by an applicant for licence or by a licensee to the Licensing Authority.- The applicant for the grant of licence or any person granted a licence under the Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation, rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter, which may be required for the purpose of verifying the correctness of the statement made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.

122-O. Cancellation and suspension of licences.− (1) The Licensing Authority or Central Licence Approving Authority may for such licences granted or renewed by him after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reason thereof, cancel a licence issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates¹[or direct the licensee to stop collection, storage, processing, manufacture and distribution of the said substances and²[thereupon order the destruction of substances and] stocks thereof in the presence of an Inspector], if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder.

(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1) prefer an appeal against the order to the State Government or Central Government, which shall decide the same.

122-P. Conditions of licence.- ³[A licence in Form 28C, Form 28E,⁴[Form 28F, Form 26G, Form 26-I or Form 28J shall be subject to the special conditions set out in Schedule F, Part XII-B and Part XII C, Part XIID,] as the case may be, which relate to the substance in respect of which the licence is granted or renewed and to the following general conditions, namely:-]

(i) (a) The licensee shall provide and maintain adequate staff, plant and premises for the proper operation of a Blood Bank for processing whole human blood, its components and/or manufacture of blood products.

(b) The licensee shall maintain staff, premises and equipment as specified in Rule 122-G. The licensee shall maintain necessary records and registers as specified in Schedule F, Parts XII-B and XII-C.

(c) The licensee shall test in his own laboratory whole human blood, its components and blood products and maintain records and registers in respect of such tests as specified in Schedule F, Parts XIIB and XIIC⁵[or XIID]. The records and register shall be maintained for a period of five years from the date of manufacture.

(d) The licensee shall maintain/preserve reference sample and supply to the Inspector the reference sample of the whole human blood collected by him in an adequate quantity to conduct all the prescribed tests. The licensee shall supply to the Inspector the reference sample for the purpose of testing.

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(ii) The licensee shall allow an Inspector appointed under the Act to enter, with or without prior notice, any premises where the activities of the Blood Bank are being carried out for the processing of Whole Human Blood and/or Blood Products, to inspect the premises and plant and the process of manufacture and the means employed for standardizing and testing the substance.

(iii) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and to take samples of the manufactured product and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and rules thereunder have been observed.

(iv) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the operation of a Blood Bank/processing of whole human blood for components and/or manufacture of blood products and any material alterations in the premises or plant used for that purpose which have been made since the date of last inspection made on behalf of the Licensing Authority before the grant of the licence.

(v) The licensee shall on request furnish to the Licensing Authority, or Central Licence Approving Authority or to such Authority as the Licensing Authority, or the Central Licence Approving Authority may direct, from any batch unit of drugs as the Licensing Authority or Central Licence Approving Authority may from time to time specify, sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish full protocols of the test which have been applied.

(vi) If the Licensing Authority or the Central Licence Approving Authority so directs, the licensee shall not sell or offer for sale any batch/unit in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sales of batch/unit has been issued to him by or on behalf of the Licensing Authority or the Central Licence Approving Authority.

(vii) The licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch/unit of the substance has been found by the Licensing Authority or the Central Licence Approving Authority not to conform with the standards of strength, quality or purity specified in these Rules and on being directed so to do, withdraw, from sales and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch/unit.

(viii) No drug manufactured under the licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. Further no batch/unit manufactured under this licence shall be supplied/distributed to any person without prescription of a Registered Medical Practitioner.

(ix) The licensee shall comply with the provisions of the Act and of these Rules and with such further requirements, if any, as may be specified in any Rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the Rules, these would come in force four months after publication in the Official Gazette.

(x) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and defects noticed.

(xi) The licensee shall destroy the stock of batch/unit which does not comply with standard tests in such a way that it would not spread any disease/infection by way of proper disinfection method.

154

Drugs and Cosmetics Rules 1945 1 [(xii) All bio-medical waste shall be treated, disposed of or destroyed as per the provisions of the Bio-Medical Wastes (Management and Handling) Rules,

1996.

(xiii) The licensee shall neither collect blood from any professional donor or paid donor nor shall he prepare blood components and/or manufacture blood products from the blood drawn from such a donor.]

PART XI

EXEMPTIONS

123. The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.

PART XII

STANDARDS

2 [124. Standards of drugs: -

(1) For drugs included in the Indian Pharmacopoeia—

(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the Indian Pharmacopoeia for the time being in force.

(b) In case the standards for identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia.

(2) For other drugs-

(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the official pharmacopoeia, for the time being in force, of any country to which the drug claims to comply with,

(b) In case the standards for identity, purity and strength for drugs are not specified in the edition of such official pharmacopoeia for the time being in force, but are specified in the edition immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of such official pharmacopoeia to which the drug claims to comply with.

(c) For drugs for which standards are not included in the edition of the official pharmacopoeia, for the time being in force, of any country or in edition immediately preceding, but included in the official compendia of drug standards, namely, the British Pharmaceutical Codex or the National Formulary of the United States, for the time being in force, to which the drug claims to comply with.] 3 [124A. Standards for veterinary drugs. -For drugs intended for veterinary use, the standards shall be those given in the current edition for the time being in force of the 4 [British Pharmacopoeia (Veterinary)].

1. Subs. by G.S.R. 245(E), dt. 5-4-1999.

2. Subs. by G.S.R. 19, dt. 15-12-1977.

3. Ins. by notification F. 1-6/62-D (SO 2889), dt. 2-7-1969.

4. Subs. by G.S.R. 647 (E), dt. 28-10-1998.

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Drugs and Cosmetics Rules 1945 1 [124B. Standards for patent or proprietary medicines.— The standards for patent or proprietary medicines shall be those laid down in Schedule V and such medicines shall also comply with the standards laid down in the Second Schedule to the Act. 2 [124C. Standards for Surgical Dressings.-The standards for Surgical Dressings shall be such as are laid down in Schedule F (II).]

3 [124D. Standards for Sterilised Umbilical tapes.- The standards for Sterilised Umbilical tapes shall be as laid down in Schedule F(III).]

4 [125. Standards for substances (other than food) intended to affect the structure or any function of human body—contraceptives.—(1) The standards for mechanical contraceptives shall be such as are laid down in Schedule R.

(2) The standards which other contraceptives will have to comply with shall be in conformity with the formulae approved as safe and efficacious by the Central Government. Such formula shall be displayed on the label of every container of such contraceptive. 5 [125A. Standards for Medical Devices. —The standards for the Medical Devices shall be such as are laid down in Schedule R-1.]

6 [126. Standards for substances intended to be used for the destruction of vermin or insects which cause ⁹[***] disease in human beings or animals.- Disinfectants. The standards of disinfectants shall be such as are laid down in Schedule O.] 7 [126A Standards for ophthalmic preparations 8 [including Homoeopathic ophthalmic preparations].—The standards for ophthalmic preparations⁸[including Homoeopathic ophthalmic preparations] shall be those laid down in Schedule FF, and such preparations shall also comply with the standards set out in the Second Schedule to the Act.]

1. Ins. by G.S.R. 665, dt. 28-5-1977.

2. Ins. by G.S.R. 318 (E), dt. 1-5-1984.

3. Ins. by G.S.R. 1115 (E), dt. 30-9-1986.

4. Amended by F-1-28/65D (SO 886), dt. 8-3-1966.

5. Ins. by G.S.R. 109 (E), dt. 22-2-1994.

6. Amended by F.1-20/60-D, dt. 24-1-1964.

7. Ins. by F 1-113/60-D (SO 23), dt. 23-12-1969.

8 . Subs. by G.S.R. 245 (E), dt. 17-6-1996.

9. Subs heading "Insecticides" and the entry relating thereto omitted by GSR 139, dt. 8-1-1976.

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Drugs and Cosmetics Rules 1945 1 [127. List of colours permitted to be used in drugs.−(1) No drug shall contain a colour other than specified below :-

(1) Natural Colours

Annatto Carotene Chlorophyll Cochineal Curcumin Red Oxide of iron Yellow Oxide of iron 2 [Titanium Oxide] 3 [Black Oxide of iron] 6 [Titanium dioxide coated mica pearlescent pigments]

(2) Artificial Colours Caramel

4 [Riboflavin]

(3) Coal Tar Colours Common name of the colour Colour Index Chemical Name Number

1 2 3

GREEN

Quinazarine Green S.S. 61565 1, 4-bis (p-Toluino) anthraquinone. Alizarin Cyanine Green F. 61570 Disodium salt of 1, 4-bis (O-sulfo-p- Toluino) anthra-quinone.

2 [Fast Green F.C.F. 42053 Disodium salt of 4-{[4-(N-ethyl-p Sulfobenzylamino)-phenyl-]-(4-hydroxy-

2- sulfoniumphenyl)-methylene}

[1-(N-ethyl-N-p-sulfobenzyl]∆

2, 5-cyclohexadienimine].

5 [** * * *]

YELLOW

Tartrazine 19140 Trisodium salt of 3-carboxy-5- hydroxy-l- p-sulfophenyl-4-p- Sulfophenyl

azopyrazole.

Sunset Yellow FCF 15985 Disodium salt of 1-p-sulfophenyl azo-2- naphthol-6-sulfonic acid.

1. Amended by S.O. 289, dt. 20-12-1972.

2. Ins. by X.11013/3/76-DM.S (SO 1074), dt. 19-8-1978.

3. Ins. by G.S.R. 370 (E), dt. 7-4-1994.

4. Ins. by G.S.R. 681 (E), dt. 6-6-1988.

5. "Green S" omitted by G.S.R. 753 (E), dt. 4-11-1999.

6. Ins. by G.S.R. 76 (E), dt. 8-2-2012.

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(1) (2) (3)

1 [Quinoline Yellow WS 47005 Disodium salt of disulfonic acid of 2(2- quinolyl)-1, 3-indandione.]

RED

2 [** ** *] Erythrosine 45430 Disodium salt of 9-0-carboxyphenyl 6-hydroxy 2,4-5,7-tetriodo-3-isoxanthone

Eosin YS or Eosine G 45380 Disodium of salt of 2,4,5, 7-Tetrabromo- 9-p- carboxyphenyl-6-hydroxy 3-isoxanthone.

Toney Red or Sudan III 26100 1-p-phenylazophenylaze-2-naphthol. Ponceau 4 R 16255 Trisodium salt of 1-(4-sulpho-1-1- Napthylazo)- 2 napthol-6 : 8-disulphonic acid.

Carmoisine 14720 Disodium salt of 2-(4-sulpho-1-napthylazo)-1 napthol-4 sulphonic acid.

3 [*** * *]

BLUE

73015 Disodium salt of indigotin-5 : 5 Disu lphonic Indigo Carmine Acid

4 [Brilliant Blue FCF 42090 Disodium salt of 4-[ {4-(N-ethyl-p- sulfobenzylamino)-phenyl }-](2- sulfonium

phenyl)-methylene)-1-(N- ethyl-N-p-

sulfobenzyl)- ∆ 2, 5-cyclohexadienimine.

ORANGE

Orange G 16230 Disodium salt of 1-phenylazo-2- naphthol-6, 8- disulfonic acid.

BROWN

Resorcin Brown 20170 Monosodium salt of 4-p-sulfophenylazo-2-(2, 4- xylylazo-1, 3 resorcinol.

BLACK

Naphthol Blue Balck 20470 Disodium salt of 8-amino-7-p-nitro- phenylazo- 2-phenylazo-1-naphthol-3, 6-disulfonic acid.

1. Subs. by G.S.R. 11(E), dt. 7-1-1991.

2. 'Amaranth' omitted by G.S.R. 753(E) dt. 4.11.1999.

3. Fast Red omitted by G.S.R. 753, dt. 4-11-1999.

4. Ins. by X.11013/3/76-DM.S, dt. 19-8-1978.

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Drugs and Cosmetics Rules 1945

(4) LAKES

The aluminum or calcium salts (lakes) of any of the water-soluble colours listed above:

⁵[Provided that disinfectants may also contain colours specified under Schedule Q, which are non-staining.]

(2) The label on the container of a drug containing a permitted colour shall indicate the common name of the colour.]

128. The following rules are hereby repealed except as respects things done or omitted to be done under these rules, namely :---

Andhra Pradesh Drugs Rules, 1945.

Assam Drugs Rules, 1945.

Bihar Drugs Rules, 1945.

Bombay Drugs Rules, 1946.

East Punjab Drugs Rules, 1945.

C.P. & Berar Drugs Rules, 1945.

Madras Drugs Rules, 1945.

Orissa Drugs Rules, 1945.

Rajasthan Drugs Rules, 1953.

Saurashtra Drugs Rules, 1953.

Travancore-Cohin Drugs Rules, 1953.

United Provinces Drugs Rules, 1945.

West Bengal Drugs Rules, 1946.

2 [Mysore Drugs Rules, 1954].

1 [PART XIII

3 [IMPORT AND REGISTRATION OF COSMETICS]

4 [129. Registration of cosmetic products imported into the country.- No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.

129A. Form and manner of application for Registration Certificate.- (1) An application for issue of a Registration Certificate for cosmetics intended to be imported into India shall be made in Form 42 either by the manufacturer himself or by his authorised agent or importer in India or by the subsidiary in India authorised by the manufacturer and shall be accompanied by a fee of two hundred and fifty US dollars or its equivalent to Indian rupees for each brand of cosmetic. The application shall be accompanied by a treasury challan as specified in sub- rule (3) along with the information and undertaking as specified in Schedule D (III) duly signed by or on behalf of the manufacturer or by his authorised agent or importer in India or by the subsidiary in India authorised by the manufacturer.

1. Ins. by G.S.R. 1183 dt. 17-8-1964. 5. Ins. by G.S.R. 76 (E), dt. 8-2-2012.

2. Added by notification F. 1-37/58-D, dt. 21-7-1958.

3. Subs. by G.S.R. 426 (E), dt. 19-5-2010.

4. Rules 129 to 129H subs. by G.S.R. 426 (E), dt. 19-5-2010.

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(2) An authorisation by the manufacturer to his agent in India shall be duly authenticated either in India before a First Class Magistrate or in the country of origin before such an equivalent authority.

(3) The fees shall be paid through a challan in the designated branches of Bank of Baroda either in US dollars or in equivalent Indian rupees under Head of Account "0210-MEDICAL AND PUBLIC HEALTH, 04 PUBLIC HEALTH, 104-FEES AND FINES" and the original copy of the treasury challan shall be submitted along with the application for product registration.

Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account "0210-MEDICALAND PUBLIC HEALTH, 04 PUBLIC HEALTH, 104-FEES AND FINES" and the original receipt of the said transfer shall be treated as an equivalent to the bank challan subject to the approval by the Bank of Baroda that they have received the payment.

(4) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government, as may be, required for examination, tests and analysis of cosmetics.

(5) A fee of one hundred US dollars or its equivalent shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.

129B. Registration Certificate for the import of cosmetics manufactured by one manufacturer.-A single application may be made and a single Registration Certificate in Form 43 may be issued in respect of import of one or more than one cosmetics manufactured by the same manufacturer: Provided that the cosmetics are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit.

129C. Grant of Registration Certificate.- (1) On receipt of an application for Registration Certificate in the form and manner specified in rule 129A, the licensing authority shall, if satisfied, issue a Registration Certificate in form 43 subject to the conditions of the registration certificates in form 43:

Provided that if the application is complete in all respects and information specified in Schedule D III is in order, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit.

(2) If the applicant does not receive the Registration Certificate within the period as specified above, he may appeal to the Central Government and the Central Government may after such enquiry into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.

129D. Duration of Registration Certificate.- A Registration Certificate, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue:

Provided that if application for a fresh Registration Certificate is made within six months before the expiry of the said certificate, the existing Registration Certificate shall be deemed to continue to remain in force until orders are passed on the application.

129E. Suspension and cancellation of Registration Certificate.- If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the cosmetics to which it relates: Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the said appellant an opportunity of being heard pass orders as it thinks fit.

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Drugs and Cosmetics Rules 1945

129F. Prohibition of import of certain cosmetic.- No cosmetic, the manufacture, sale or distribution of which is prohibited in the county of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.

129G. Standard for imported cosmetics.- No cosmetic shall be imported unless it complies with the specifications prescribed under Schedule S and Schedule Q or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case the cosmetic is not included under Schedule S, it shall meet with specifications under the rules and standards applicable to it in the country of origin.

129H. Labeling and Packing of Cosmetics.- No cosmetic shall be imported unless it is packed and labeled in conformity with the rules in Parts XV. Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India.]

130. Documents to be supplied to the Collector of Customs.− Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the Rules made there under, shall be supplied to the Collector of Customs.

131. Procedure for the import of cosmetics.− (1) If the officer appointed at the post of entry by the Central Government has reason to believe that any cosmetic contravenes any of the provisions of the Act or the rules made thereunder he may take sample of the cosmetic from the consignment for inspection. If on examination of the sample defects are noticed the officer shall advise the Collector of Customs for further action to be taken. If the suspected contravention of the provisions of the Act or the Rules is such as may have to be determined by test, the officer shall send the sample to the laboratory established for the purpose for performing such tests. The consignment of the said cosmetic shall be detained till such time that the test report on such sample is received from the Director of the said laboratory or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government:

Provided that if the importer gives an undertaking in writing not to dispose of the cosmetic without the consent of the Collector of Customs and to return the consignment or such portion thereof as may be required, the Collector of Customs shall make over the consignment to the importer.

(2) If the importer who has given an undertaking under the proviso to sub-rule (1) is required by the Collector of Customs to return the consignment or portion thereof, he shall return the consignment or portion thereof within ten days of receipt of the notice. Further procedure on receipt of the report of analysis

(3) If the Director of the Laboratory established for the purpose by the Central Government or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government, reports to the Collector of Customs or to the officer mentioned in sub-rule (1) above that the sample of any cosmetic in a consignment contravenes the provisions of Chapter III of the Act or the Rules made thereunder and that the contravention is such that it cannot be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer who shall within two months of receiving such a communication either send back all the cosmetic of that description to the country in which it was manufactured or to the country from which it was imported or hand it over to the Central Government which shall cause it to be destroyed:

Provided that the importer may within thirty days of receipt of the report make a representation against the report to the Collector of Customs who shall forward the representation with a fresh sample of the cosmetic to the Drugs Controller, India, who after

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Drugs and Cosmetics Rules 1945 obtaining, if necessary, the report of the Director of the Central Drugs Laboratory shall pass orders thereon which shall be final.

(4) If the Drugs Controller or any other officer empowered by him in this behalf with the approval of Central Government reports to the Collector of Customs after the inspection of the sample of cosmetic and if necessary, after obtaining a test report thereon that the sample of the said cosmetic contravenes in any respect the provisions of Chapter III of the Act or the Rules made thereunder but that the contravention is such that it can be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer and permit him to import the cosmetic on his giving an undertaking in writing not to dispose of the cosmetic without the permission of the officer authorised in this behalf by the Central Government.

132. Exemption of cosmetics—Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.

133. Import through points of entry—No cosmetic shall be imported into India except through the points of entry specified in rule 43A.

1 [134. Cosmetic to contain Dyes, Colours and Pigments.- No Cosmetic shall contain Dyes, Colours and Pigments other than those specified by the Bureau of Indian Standards (IS:4707 Part 1 as amended) and Schedule Q.

The permitted Synthetic Organic Colours and Natural Organic Colours used in the Cosmetic shall not contain more than:-

(i) 2 parts per million of arsenic calculated as arsenic trioxide.

(ii) 20 parts per million of lead calculated as lead.

(iii) 100 parts per million of heavy metals other than lead calculated as the total of the respective metals.]

2 [134-A Prohibition of import of cosmetic containing Hexachlorophene.— No cosmetic containing hexachlorophene shall be imported.

135. Import of cosmetic containing Lead or Arsenic compound prohibited.—No cosmetic shall be imported in which a Lead or Arsenic compound has been used for purposes of colouring.

3 [135-A. Import of cosmetics containing mercury compounds prohibited.-No cosmetic shall be imported which contains mercury compounds.] 5 [135-B. Prohibition of import of cosmetics tested on animals.-No cosmetic that has been tested on animals after the commencement of the Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be imported into the country.]

136. Import of cosmetic for personal use—Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions: —

(i) The cosmetics shall form part of a passenger's baggage and shall be the property of and intended for, the bona fide use of the passenger; and

(ii) The cosmetics shall be declared to the Customs authorities, if they so direct.

4 [PART XIV

MANUFACTURE OF COSMETIC FOR SALE

OR FOR DISTRIBUTION]

137. Manufacture on more than one set of premises. — If cosmetics are manufactured on more than one premises, a separate application for each such premises shall be made and a separate licence obtained for each such premises.

1. Subs. by G.S.R. 811 (E), dt. 14-11-1994. 2. Added by G.S.R. 116, dt. 25-1-1975.

3. Ins. by X.11013/76-D & MS, dt. 19-8-1978. 4. Subs. by G.S.R. 788 (E), dt. 10-10-1985.

5. Ins. by G.S.R. 718 (E), dt. 13-10-2014.

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Drugs and Cosmetics Rules 1945

138. Application for ⁵

[licence to manufacture cosmetics for sale and distribution]— 3 [(1) Application for grant or renewal of 5 [ licence to manufacture any cosmetic for sale or for distribution]¹[shall be made up to ten items of each category of cosmetics categorized in Schedule MII to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) in Form 31 and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection

thereof or for the purpose of renewal of licence].

2 [* * * **]

3 [(2) If a person applies for the renewal of licence after expiry but within six months of such expiry, the fee payable for the renewal of such licence shall be¹[rupees two thousand five hundred plus an additional fee at the rate of rupees four hundred per month or part thereof in addition to an inspection fee of rupees one thousand.] 2 [* * * * *]

(3) Application by a licensee to manufacture additional items of cosmetics shall be accompanied by a fee of¹[rupees one hundred for each item subject to a maximum of rupees three thousand for each application.]

2 [* * * * *]

6 [(4) A fee of 1 [rupees two hundred and fifty] shall be paid for a duplicate copy of a licence under sub-rule (1), if the original is defaced, damaged or lost.] 4 [138A. Application for loan licence to manufacture cosmetics.−(1) Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics¹[shall be made up to ten items of each category of cosmetics categorized in Schedule M-II in Form 31-A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof]. Explanation.--For the purpose of this rule a 'loan licence' means a licence, which a Licensing Authority may issue to an applicant who does not have his own arrangements to manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.

(2) If a person applies for the renewal of a loan licence after the expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be

1 . Subs. by G.S.R. 601 (E), dt. 24-8-2001 .

2. Omitted by G.S.R. 331(E),dt. 8.5.1984.

3. Amended by G.S.R. 245, dt. 21.2.1976.

4. Ins. by G.S.R. 444, dt. 28-4-1973.

5. Subs. by G.S.R. 788 (E), dt. 10-10-1985.

6. Subs. by G.S.R. 331(E),dt. 8.5.1984.

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164

Drugs and Cosmetics Rules 1945 1 [(2) The factory premises shall comply with the requirements and conditions specified in Schedule M-II.]

2 [ * * * * *]

(5) The applicant shall either--

(i) provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture; or

(ii) make arrangements with some institution approved by the Licensing Authority 3 [under Part XV (A) of these rules] for such tests to be regularly carried out in this behalf by the institution.

4 [139A. Form of 5 [licence to manufacture cosmetics for sale or for distribution].—A 5 [licence to manufacture cosmetics for sale or for distribution] against application in Form 31, shall be granted in Form 32.]

6 [139AA. Inspection before grant or renewal of licence.- Before a licence under this Part is granted or renewed in Form 32, Form 32A or Form 33, the Licensing Authority shall cause the establishment, in which the manufacture is proposed to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plant, testing equipments and the requirements of plant and equipments as laid down in Schedule M-II read with requirements of maintenance of records as laid down in Schedule U-1.]

6 [139AB. Report by Inspector.- The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection along with his or their recommendations after completion of his or their inspection to the Licensing Authority.]

6 [139AC. Grant or refusal of licence.- (1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that the conditions of the licence and the rules under the Act shall be observed, he shall grant or renew a licence in form 32, Form 32-A or Form 33.

1. Subs. by G.S.R. 723 (E), dt. 11-8-1992.

2. Omitted condition (3) and (4) by G.S.R. 723 (E), dt. 11-8-1992.

3. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.

4. Ins. by G.S.R. 444, dt. 28-4-1973.

5. Subs. by G.S.R. 788 (E), dt. 10-10-1985.

6. Ins. by G.S.R. 493 (E), dt. 9-6-1995.

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(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of inspection report.]

1 [139AD. Further application after rejection.-If within a period of six months from the rejection of an application for a licence, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection²[fee of rupees two hundred and fifty], the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of licence have been complied with, issue a licence in Form 32, Form 32-A or Form 33.]

1 [139AE. Appeal to the State Government.- Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a licence under this Part may, within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.]

3 [139B. Form of loan 4 [licence to manufacture cosmetics for sale or for distribution].−A loan⁴[licence to manufacture cosmetics for sale or for distribution] against application in Form 31-A shall be granted in Form 32-A.

140. Duration of licence.- An original licence or a renewed licence shall unless sooner suspended or cancelled be²[valid for a period of five years on and from the date on which] it is granted or renewed:

5 [Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired, if application for its renewal is not made within six months of its expiry.]

141. Certificate of renewal.−The certificate of renewal of a licence in Form 32 shall be issued in Form 33.

1. Ins. by G.S.R. 493 (E), dt. 9-6-1995.

2 . Subs. by G.S.R. 601 (E), dt. 2 4-8-2 001.

3. Ins. by G.S.R. 444, dt. 28-4-1973.

4. Subs. by G.S.R. 493 (E), dt. 9-6-1995.

5. Amended by S.O. 2139, dt. 12.8.1972.

166

Drugs and Cosmetics Rules 1945 1 [141A. Certificate of renewal of a loan licence—The certificate of renewal of a licence in Form 32-A shall be issued in Form 33-A.]

1 [141AA. Duration of a loan licence.-An original loan licence in Form 32A or a renewed loan licence in Form 33-A, unless sooner suspended or cancelled, shall be²[valid for a period of five years on and from the date on which] it is granted or renewed:

Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]

142. Conditions of licence—A licence in Form 32 shall be subject to the conditions stated therein and to the following other conditions, namely: -

(a) the licensee shall provide and maintain staff, premises and equipment as specified in rule 139;

(b) the licensee shall comply with the provisions of the Act and the Rules made thereunder and with such further requirements, if any, as may be specified in any rules to be made hereafter under Chapter IV of the Act;

3 [(b1) the licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years;]

(c) the licensee shall test each batch or lot of the raw materials used by him for the cosmetics and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests. The records or registers shall be retained for a period of three years from the date of manufacture;

(d) the licensee shall allow any¹

[ Inspector appointed under the Act] to enter with or without prior notice any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured products under a receipt;

1 . Ins. by G.S.R. 444, dt. 28-4-1 973.

2. Subs. by G.S.R. 601 (E), dt. 24-8-2001.

3. Ins. by G.S.R. 1594, dt. 28-10-1976.

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(e) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules made thereunder have been complied;

1 [(f) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and the defects noticed:

2 [Provided that clauses (b-1) and (c) shall not apply to the manufacture of soap and the procedure for testing of raw materials and the records to be maintained by the manufacturer of soap shall be such as are approved by the Licensing Authority.]

4 [142A. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority.—The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence as the case may be.]

1 [142B. Conditions of licence in Form 32-A.-

(a) A licence in Form 32-A shall be deemed to be cancelled or suspended, if the licence owned by the licensee, in Form 32, whose manufacturing facilities are cancelled or suspended, as the case may be under these rules.

(b) The licensee shall comply with the provisions of the Act and these rules and with each further requirements, if any, as may be specified from time to time in Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.

3 [(b1) The licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years.]

(c) The licensee shall test each batch or lot of the raw materials used by him for the manufacture of the cosmetics and also each batch of the final product and shall maintain records of registration showing the particulars in respect of such tests. The records or registers shall be retained for a period of three years from the date of manufacture.

1. Ins. by G.S.R. 444, dt. 28-4-1973.

2. Ins. by G.S.R. 681 (E), dt. 6-6-1988.

3. Ins. by G.S.R. 1594, dt. 28-10-1976.

4. Ins. by S.O.2139, dt. 12-8-1972.

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(d) The licensee shall allow an Inspector appointed under the Act to enter with or without prior notice any premises where the manufacture of a substance in respect of which licence is issued is carried on, to inspect the premises and to take samples of the manufactured products under a receipt.

(e) The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act, and the rules made thereunder have been complied.

(f) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]

143. Cancellation and suspension of licence.−(1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or the rules made thereunder.

(2) A licensee whose license has been suspended or cancelled may appeal within a period of three months from the date of the order to the State Government which shall after considering the appeal, pass orders, and such orders shall be final. 1 [144. Prohibition of manufacture of cosmetics containing colours other than those prescribed.- No Cosmetic shall be manufactured which contains Dyes, Colours and Pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q.

The permitted Synthetic Organic colours and Natural Organic colours used in the Cosmetic shall not contain more than−

(i) 2 parts per million of arsenic calculated as arsenic trioxide.

(ii) 20 parts per million of lead calculated as lead.

(iii) 100 parts per million of heavy metals other than lead calculated as the total of the respective metals.]

2 [144A. Prohibition of manufacture of cosmetics containing Hexachlorophene.—No cosmetic containing Hexachlorophene shall be manufactured:]

1. Subs. by G.S.R. 811(E), dt. 14-11-1994.

2. Ins. by G.S.R. 116, dt. 15.1.1975.

169

Drugs and Cosmetics Rules 1945 1 [Provided that in the case of soaps Hexachlorophene may be used in concentrations not exceeding one per cent weight by weight:

Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely:-

"Contains Hexachlorophene - not to be used on babies".]

145. Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited.—The use of Lead and Arsenic compounds for the purpose of colouring cosmetics is prohibited.

2 [145A. Form of intimation for purpose of taking samples of cosmetics.—Where an Inspector takes a sample of a cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.] 3 [145AA. Form of receipt of samples of cosmetics where fair price tendered is refused.- Where the fair price, for the samples of Cosmetics taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17A.]

2 [145B. Form of receipt for seized cosmetics.−A receipt by an Inspector for the stock of any cosmetic seized under clause (c) of sub-section (1) of section 22 of the Act shall be in Form 15.]

4 [145BA. Manner of certifying copies of seized documents.-The Drugs Inspector shall return the documents, seized by him under clause (cc), or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they were seized or, as the case may be, the person who produced them, after copies thereof or extracts therefrom have been signed by the Drugs Inspector concerned and the person from whom they were seized, or, as the case may be, who produced such records.]

5 [145C. Form of order not to dispose of stocks of cosmetics—An order in writing by an Inspector under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock of cosmetics in his possession shall be in Form 15.] 6 [145D. Prohibition of manufacture of cosmetics containing mercury compounds.- No cosmetics containing mercury compounds shall be manufactured.]

1. Ins. by G.S.R. 1049 (E), dt. 29-8-1986.

2. Ins. by S.O. 2139, dt. 5.6.1972.

3. Ins. by G.S.R. 292 (E), dt. 29-5-1997.

4. Ins. by G.S.R. 89(E), dt. 16-2-1985.

5. Ins. by G.S.R. 1594, dt. 28-10-1976.

6. Ins. by G.S.R. 1074, dt. 19.8.1978 (w.e.f. 2.9.1978).

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PART XV

1 [LABELLING, PACKING AND STANDARDS OF COSMETICS]

146. Prohibition of sale or distribution.-Subject to other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules.

2 [147. Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part.- Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adopted to meet the specific requirements, if any, of the consignee:

Provided that where a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in rule 21.]

148. Manner of labelling.-Subject to other provisions of the rules, a cosmetic shall carry.-

(1) on both the inner and outer labels;

(a) the name of the cosmetic, 3 [(b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured.

Provided that if the cosmetic is contained in a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.]

(2) On the outer label.- A declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi-solids, combined with numerical count if the content is sub-divided:

Provided that this statement need not appear in case of a package of perfume, toilet water or the like the net content of which does not exceed 60 ml or any package of solid or semi- solid cosmetic the net content of which does not exceed 30 grams.

(3) On the inner label, where a hazard exists-

(a) adequate direction for safe use,

(b) any warning, caution or special direction required to be observed by the consumer,

(c) a statement of the names and quantities of the ingredients that are hazardous or poisonous.

1. Subs. by S.O. 3408, dt. 1.11.1996.

2. Subs. by G.S.R. 682 (E), dt. 5-12-1980.

3. Subs. by G.S.R. 352 (E), dt. 26-4-2000.

171

Drugs and Cosmetics Rules 1945 1 [(4) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter "B":

Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state, and 25 millilitres or less if the cosmetic is in a liquid state:

2 [Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.]

1 [(5) manufacturing licence number, the number being preceded by the letter 'M'.]

(6) Where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these Rules. 5 [(7) The list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume at the time they are added, followed by those inconcentration of less than or equal to one percent, in any order, and preceded by the words 'INGREDIENTS'.

Provided that this statement need not appear for packs of less than 60 ml of liquid and30 gm of solid and semi-solids.

(8) Labeling requirement, if any, specified in the relevant Indian standard as laid down by the 'Bureau of Indian Standards' for the cosmetics covered under Schedule S.] 3 [148A. Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics.- No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic:

Provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority.]

5 [148B - Prohibition against false or misleading claims :- No cosmetic may purport or claimto purport or convey any idea which is false or misleading to the intending user.]

149. ⁴[Labelling of Hair dyes containing Dyes, Colours and Pigments.—Hair dyes containing Para-Phenylenediamine or other Dyes, Colours and Pigments] shall be labelled with the following legend in English and local languages and these shall appear on both the inner and the outer labels.

"Caution—This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying direction should first be made. This product should not be used for dyeing the eye-lashes or eye-brows; as such a use may cause blindness".

Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:

"This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that

1. Subs. by G.S.R. 245, dt. 3-2-1976.

2. Ins. by. 681(E), dt. 6-8-1988.

3. Ins. by G.S.R. 351 (E), dt. 26-4-2000.

172

Drugs and Cosmetics Rules 1945 no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eye- brows or eye-lashes as severe inflammation of the eye or even blindness may result.] 1 [149A. Special provisions relating to toothpaste containing fluoride.-

(i) Fluoride content in tooth paste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.

(ii) Date of expiry should be mentioned on tube and carton.]

150. Report of result of test or analysis of cosmetics.—Test reports on samples of cosmetics taken for test or analysis under these rules shall be supplied in Form 34.

173

Drugs and Cosmetics Rules 1945 Explanation—For the purpose of this Part, the words 'drugs' and 'cosmetics' shall also mean and include the raw materials used in the manufacture of drugs including Homoeopathic drugs or cosmetics, as the case may be.]

150-C. Form in which approval to be granted for carrying out tests on drugs / cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for grant or renewal of such approval.- (1) Approval for carrying out such tests of identity, purity, quality and strength of drugs or cosmetics as may be required under the provisions of these rules, on behalf of licensee for manufacture of drugs or cosmetics shall be granted in Form 37.

(2) Before approval in Form 37 is granted or renewed, the following conditions shall be complied with by the applicant-

(1) The premises where the tests are being carried out shall be well lighted and properly ventilated except where the nature of tests of any drug or cosmetic warrants otherwise. Wherever necessary, the premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc.

(2) The applicant shall provide adequate space having regard to the nature and number of samples of drugs or cosmetics proposed to be tested. Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate.

(3) If it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal house and comply with the following requirements-

(a) The animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests shall be kept in air conditioned area.

(b) The animals shall be suitably housed in hygienic surroundings and necessary provisions made for removal of excreta and foul smell.

(c) The applicant shall provide for suitable arrangements for preparation of animal feed.

(d) The applicant shall provide for suitable arrangements for quarantining of all animals immediately on their receipt in the institution.

(e) The animals shall be periodically examined for their physical fitness.

(f) The applicant shall provide for isolation of sick animals as well as animals under test.

(g) The applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960).

(h) The applicant shall make proper arrangements for the disposal of the carcasses of animals in a manner as not to cause hazard to public health.

(4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of drugs or cosmetics intended to be tested which shall be adequate in the opinion of the approving authority.

(5) The testing of drugs or cosmetics, as the case may be, shall be under the active direction of a person whose qualifications and experience are considered adequate in the opinion of the approving authority and who shall be held responsible for the reports of test or analysis issued by the applicant.

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(6) The testing of drugs or cosmetics, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualifications and experience of testing are adequate in the opinion of the approving authority.

(7) The applicant shall provide books of standards recognized under the provisions of the Act and the Rules made thereunder and such books of reference as may be required in connection with the testing or analysis of the products for the testing of which approval is applied for.

150D. Duration of approval. -An approval granted in Form 37 or renewed in Form 38, unless sooner suspended or withdrawn, shall be¹[valid for a period of five years on and from the date on which] it is granted or renewed:

Provided that if an application for the renewal of an approval in Form 37 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional fee, the approval shall continue to be in force until orders are passed on the applications and the approval shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.

150E. Conditions of approval -An approval in Form 37 shall be subject to the following general conditions: —

(a) The institution granted approval under this Part (hereinafter referred to as the approved institution) shall provide and maintain an adequate staff and adequate premises and equipment as specified in rule 150-C²[and Schedule L-1].

(b) The approved institution shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.

(c) The approved institution shall maintain records of tests for identity, purity, quality and strength carried out on all samples of drugs or cosmetics and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which an expiry date is assigned for a period of two years from the expiry of such date and in the case of other substances for a period of six years.

(d) The approved institution shall allow the Inspector appointed under this Act to enter with or without prior notice the premises where the testing is carried on and to inspect the premises and the equipment used for test and the testing procedures employed. The institution shall allow the Inspectors to inspect the registers and records maintained under these Rules and shall supply to such Inspectors such information as they may require for the purpose of ascertaining whether the provisions of the Act and Rules made thereunder have been observed.

(e) The approved institution shall from time to time report to the approving authority any changes in the person-in-charge of testing of drugs or cosmetics or in the expert staff responsible for testing as the case may be and any material alteration in the premises or changes in the equipment used for the purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval.

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(f) The approved institution shall furnish reports of the results of test or analysis in Form 39.

(g) In case any sample of a drug or a cosmetic is found on test to be not of standard quality, the approved institution shall furnish the approving authority¹[and the licensing authority of the State where the manufacturer and/or sender of the drug or cosmetic is located] with copy of the test report on the sample with the protocols of tests applied.

(h) The approved institution shall comply with the provisions of the Act and Rules made thereunder and with each further requirements, if any, may be specified in the rules subsequently made under Chapter IV of the Act of which the approving authority has given the approved institution not less than four months notice.

(i) The approved institution shall maintain an Inspection Book to enable the Inspectors to record his impression or defects noticed.

150F. Inspection before grant of approval.— Before an approval in Form 37 is granted, the approving authority shall cause the institution at which the testing of drugs or cosmetics, as the case may be, is proposed to be carried out to be inspected jointly by the Drugs Inspectors of the Central Drugs Standard Control Organisation and the State Drugs Control Organisation who shall examine the premises and the equipment intended to be used for testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff to be employed.

150G. Report of Inspection.— The Drug Inspector mentioned in rule 150-F shall forward to the approving authority a detailed report of the result of the inspection.

150H. Procedure of approving authority.— (1) If the approving authority after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act will be observed, he shall grant an approval in Form 37.

(2) If the approving authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before an approval could be granted.

150-I. Further application after rejection.— If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of²[rupees two hundred and fifty], the approving authority may, if, after causing a further inspection to be made, he is satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 37.

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150J. Renewal. - On an application being made for renewal the approving authority may cause an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act are and shall continue to be observed shall issue a certificate of renewal in Form 38.

150K. Withdrawal and suspension of approvals - (1) The approving authority may, after giving the approved institution an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, withdraw an approval granted under this Part or suspend it for such period as he thinks fit either wholly or in respect of some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the approved institution has failed to comply with any of the conditions of the approval or with any provisions of the Act or the Rules made thereunder.

(2) Any approved institution whose approval has been suspended or withdrawn may within three months of the date of the order, appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by it in this behalf and notified in the Official Gazette.]

1 [PART XVI

MANUFACTURE FOR SALE OF AYURVEDIC (INCLUDING SIDDHA) OR

UNANI DRUGS

151. Manufacture on more than one set of premises.—If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.

152. Licensing Authorities.—For the purpose of this Part the State Government shall appoint such Licensing Authorities and for such areas as may be specified in this behalf by notification in the Official Gazette.

153. Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs.— (1) An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with²[a fee of rupees one thousand]:

Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:

Provided further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case the²[fee payable for renewal of such licence shall be rupees one thousand and two hundred plus an additional fee of rupees six hundred].

(ii)²[A fee of rupees three hundred] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.

1. Parts XVI, XVII and XVII added by S.O. 642, dt. the 2-2-1970 (w.e.f. 21.2.1970)

2 . Subs. by G.S.R 79 (E), dt. 14-2 -2 005.

177

Drugs and Cosmetics Rules 1945 1 [153A. Loan Licence.—(i) An application for the grant of renewal of a loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25-E to the Licensing Authority along with²[a fee of rupees six hundred.] Explanation—For the purpose of this rule, a loan licence means a licence which a Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licence in Form 25-D:

Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:

Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case²[the fee payable for renewal of such licences shall be rupees six hundred plus an additional fee of rupees three hundred.]] (ii)²[A fee of rupees one hundred and fifty] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.]

154. Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs. — (1) Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The licence shall be issued within a period of three months from the date of receipt of the application.

(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani Systems of medicine as the case may be, which the State Government may approve in this behalf.

1 [154A. Form of loan licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs.—

(1) A loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25E.

(2) A licence under this rule shall be granted by the Licensing Authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be, which the State Government may approve in this behalf.

(3) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.]

155. Certificate of renewal—The certificate of renewal of a licence in Form 25-D shall be issued in Form 26-D.

1. Ins. by G.S.R. 376(E), dt. 20-7-1978.

2 . Subs. by G.S.R 79 (E), dt. 14-2 -2 005.

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Drugs and Cosmetics Rules 1945 1 [155A. Certificate of renewal of a loan licence.—The certificate of renewal of a loan licence in Form 25-E shall be issued in Form 26-E.]

2 [155B. Certificate of award of G.M.P. of Ayurveda, Siddha and Unani Drugs.— 3 [(1)]The certificate of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha or Unani drugs shall be issued to licensees who comply with the requirements of Good Manufacturing Practice of Ayurveda, Siddha and Unani drugs as laid down in Schedule T.] 4 [(2) The certificate referred to in sub-rule (1) shall be issued for a period of five years from the date of issuance of the license.]

156. Duration of licence—An original licence in Form 25-D or a renewed licence in Form 26-D, unless sooner suspended or cancelled shall be⁵[valid for a period of⁶[five years] from the date of its issue]:

Provided that if the application for the renewal of a licence is made before its expiry or within one month of its expiry after payment of the additional fee of rupees thirty, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if the application for its renewal is not made within three months of its expiry.]

1 [156A. Duration of loan licence.—An original loan licence in Form 25-E or a renewed loan licence in Form 26-E, unless sooner suspended or cancelled, shall be valid up to the 31st December of the year following the year in which it is granted or renewed:

Provided that if the application for the renewal of a loan licence is made in accordance with rule 153-A, the loan licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if the application for its renewal is not made within three months of its expiry.]

157. Conditions for the grant or renewal of a licence in Form 25-D.—Before a licence in Form 25-D is granted or renewed in Form 26-D the following conditions shall be complied with by the applicant, namely: —

(1) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in Schedule T. 2 [(IA) For issuing of the certificate of Good Manufacturing Practices, the Licensing Authority shall verify the requirements as per schedule T and issue the Good Manufacturing Practices certificate in form 26 E-I, simultaneously along with grant or renewal of licence in form 25D].

7 [(IB) No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act, except as described in the authoritative books specified in the First Schedule to the Act:

Provided that a formulation without any specific name, described in the authoritative books may be named on the basis of the ingredients of the formulation. (IC) The name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act shall not be used for naming any patent or proprietary medicine relating to Ayurvedic, Siddha or UnaniTibb systems of medicine referred to in sub-clause

(i) of clause (h) of the said section:

Provided that this rule shall not be applicable for single plant-ingredient based Ayurvedic, Siddha or UnaniTibb formulation licensed or to be licensed as patent or proprietary medicine under sub-clause (i) of clause (h) of section 3 of the Act.]

1. Ins. by G.S.R. 376 (E),dt. 20-7-1978. 7. Ins. by G.S.R. 390 (E),dt. 18.5.2015.

2. Subs. by G.S.R. 376 (E),dt. 3-5-2010. Earlier Ins. by G.S.R. 198 (E), dt. 7-3-2003.

3. Rule 155B renumbered as sub-rule (1) by G.S.R. 376 (E),dt. 3-5-2010.

4. Ins. by G.S.R. 376 (E),dt. 3-5-2010.

179

Drugs and Cosmetics Rules 1945 (ID) Notwithstanding the period for renewal of licence provided in rules 156 and

156 A, the licensee of the Ayurvedic, Siddha or UnaniTibb drug, which is not in conformity with sub-rules (1B) and (1C), shall seek renewal of the licence with appropriate name of the drug within a period of one year from the date of commencement of Drugs and Cosmetics (4^thAmendment) Rules, 2015:

Provided that this rule shall not be applicable to any batch of Ayurvedic, Siddha or UnaniTibb drugs manufactured prior to the date of commencement of the Drugs and Cosmetics (4^thAmendment) Rules, 2015.

(IE) Whoever contravenes the provisions of rules (IB) to (ID) shall be punishable under section 33-I of the Act.]

(2) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be conducted under the direction and supervision of competent technical staff consisting at least of one person, who is a whole time employee and who possesses the following qualifications, namely:-

(a) A degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of medicine, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicines recognized by the Central Government or a State Government for this purpose, or

(b) a diploma in Ayurveda, Siddha or Unani system of medicine granted by a State Government for this purpose, or

(c) a graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University recognized by the Central Government with experience of at least two years in the manufacture of drugs pertaining to the Ayurvedic or Siddha or Unani systems of medicines, or

(d) a Vaid or Hakim registered in a State Register of Practitioners of indigenous systems of medicines having experience of at least four years in the manufacture of Ayurvedic or Siddha or Unani drugs, or

(e) a qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems of medicines, possessing experience of not less than eight years in the manufacture of Ayurvedic or Siddha or Unani drugs as may be recognized by the Central Government.

(3) The competent technical staff to direct and supervise the manufacture of Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff to direct and supervise the manufacture of Siddha drugs and Unani drugs shall have qualification in Siddha or Unani, as the case may be.

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3 [157A. Maintaining of records of raw material used by licensed manufacturing unit of Ayurveda, Siddha and Unani drugs in the preceding financial year.- Each licensed manufacturing unit of Ayurveda or Siddha or Unani drugs shall keep a record of raw material used by each licensed manufacturing unit of Ayurveda, Siddha or Unani drugs as the case may be in the proforma given in Schedule TA in respect of all raw materials utilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year, and shall submit the same by the 30th day of June of the succeeding financial year to the State Drug Licensing Authority of Ayurveda, Siddha and Unani drugs and to the National Medicinal Plants Board or any agency nominated by the National Medicinal Plant Board for this purpose.]

158. Conditions of licence.—A licence in Form 25D shall be subject to the conditions stated therein and to the following further conditions, namely:-

(a) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products.

(b) The licensee shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises, to take samples of the raw material as well as finished the products, and to inspect the records maintained under these rules. 1 [(c) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]

2 [158-A. Condition of loan licence.—A licence in Form 25E shall be subject to the conditions stated therein and to the following conditions, namely:—

(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.

(b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV-A of the Act, provided that where such further requirements are specified in the rules; these would come into force four months after publication in the Official Gazette.

(c) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, of the raw materials and finished products.

(d) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules have been observed.

1 [(e) The licensee shall maintain an Inspection Book in form 35 to enable an Inspector to record his impressions and the defects noticed.]

1. Ins. by G.S.R. 331 (E),dt. 8.5.1984.

2. Ins. by G.S.R. 376 (E), dt. 20.7.1978.

3. Ins. by G.S.R. 512 (E),dt. 9.7.2008.

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Drugs and Cosmetics Rules 1945

1 [158(B) Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs.-

I. (A). Ayurveda, Siddha Unani Medicines under section 3(a):- Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;

(B). Patent or Proprietary medicine under section 3(h);

(i) In relation to Ayurvedic, Siddha and Unani Tibb system of medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb system of medicines specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);

(ii) Balya/Poshak/Muqawi/Unavuporutkal/positive health Promoter formulations having ingredients mentioned in books of First Schedule of the Drugs and Cosmetics Act and recommended for promotional and preventive health.

(iii) Saundarya Prasadak (Husane afza)/Azhagh-sadhan formulation having ingredients mentionedin Books of First Schedule of the Drugs and Cosmetics Act and recommended for oral, skin, hair and body care.

(iv) Aushadh Ghana (Medicinal plant extracts - dry/wet) extract obtained from plant mentioned in books of First Schedule of the Act including Aqueous or hydro-alcohol.

II.(A) For issue of licence to the medicine with respect to Ayurvedic, Siddha and Unani, the conditions relating to safety study and the experience or evidence of effectiveness shall be such as specified in columns (5) and (6) of The Table given below:-

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Drugs and Cosmetics Rules 1945

Ayurveda,

siddha and

Unani drugs, As per Not

3 New If Required Required referred in text Required 3(a) to be

used for new

III. For issue of license with respect to Balya and Poshak medicines the person who applied for license is required to submit the following:

(i) Photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book of 1st schedule;

(ii) Conduct safety studies in case the product contains of any of the ingredients as specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda Siddha and Unani Drugs formulations;

(iii) For textual indications the safety and effectiveness study is not required.

IV. For issue of license with respect to Saundarya Prasadak (Husane afza/Azhagu Sodhan) the person who applied for license is required to:-

(i) Submit photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book of 1st schedule;

1. Ins. by G.S.R. 663 (E),dt. 10.10.2010.

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(ii) Conduct safety studies, in case the formulation contains of any of the ingredients as specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda, Siddha and Unani formulation;

(iii) For textual indications the safety and effectiveness study is not required.

V. For issue of license with respect to medicine Aushadh Ghana extract of medicinal plant (dry or wet).

* The standard protocol will also include concept of Anupan, Prakriti & Tridosh etc.

published by Central

Research Councils Ayurveda, Siddha, Unani and other Government/Research Bodies.

** New indication means which is other than mentioned in 1st schedule books of

Drugs & Cosmetics Act 1940.]

1 [158C. Form of Free Sale Certificate and Non-Conviction Certificate. - The State Drug Controller or Licensing Authority shall, on request by the Ayurveda, Siddha and Unani Drugs manufacturer, issue, within 15 days; from the date of application, Free Sale Certificate in Form 26 E2-I for original License holder or in Form 26 E2-II for loan license and Non Conviction Certifacate for both original and loan license holder in Form 26 E3 or in the format as specified by the importing country or tenderer respectively, after fulfilment of all requisite formalities as required in the respective formats.]

1. Ins. by G.S.R. 153 (E),dt. 5.3.2014.

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159. Cancellation and suspension of licences— (1) The Licensing Authority may, after giving an opportunity to show cause within a period which shall not be less than fifteen days from the date of receipt of such notice, why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the drugs to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act and the rules made thereunder.

(2) A licensee whose licence has been suspended or cancelled may appeal to the State Government within a period of three months from the date of receipt of the order which shall, after considering the appeal, decide the same.

160. Identification of raw materials.— Raw materials used in the preparation of Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are available for their genuineness, and records of such tests as are carried out for the purpose and the methods thereof shall be maintained.

1 [PART XVI (A)

APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON AYURVEDIC,

SIDDHA AND UNANI DRUGS AND RAW MATERIALS USED IN THEIR

MANUFACTURE ON BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE

OF AYURVEDIC, SIDDHA AND UNANI DRUGS

160-A. Application for grant of approval for testing Ayurvedic, Siddha and Unani drugs.- Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of the said Ayurvedic, Siddha and Unani drugs, shall be made in Form 47 to the Licensing Authority appointed by the State Government for the purposes of Part XVI, XVII or XVIII of these rules, as the case may be, and referred to as the 'approving authority' under this Part and shall be accompanied by an inspection fee of six thousand rupees in respect of the drugs specified in the books prescribed in First Schedule to the Act.

1. Subs. by G.S.R.73 (E), dt. 31-01-2003 and earlier Ins. by G.S.R. 701(E), dt. 27-9-2001.

185

Drugs and Cosmetics Rules 1945 Provided that the applicant shall furnish to the approving authority such additional information as may be required by it in connection with the application in Form 47:

Provided further that if the applicant applies for renewal of approval after its expiry but within six months of such expiry, the inspection fee payable shall be six thousand rupees plus an additional inspection fee at the rate of one thousand rupees per month in the case of testing of Ayurvedic, Siddha and Unani drugs specified in First Schedule to the Act. Explanation. - For the purpose of this Part, the words "Ayurvedic, Siddha and Unani drugs" shall also mean and include the raw materials used in the manufacture of Ayurvedic, Siddha and Unani drugs, as the case may be.

160B. Form in which approval to be granted for carrying out tests on Ayurvedic, Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and Unani drugs and conditions for grant or renewal of such approval.-- (1) Approval for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48.

(2) Before approval in Form 48 is granted or renewed, the following conditions shall be complied with by the applicants, namely: -

(i) The premises where the tests are carried out shall be well lighted and properly ventilated except where the nature of tests of any Ayurvedic, Siddha and Unani drug warrants otherwise. Wherever necessary, the premises shall be air-conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests and microbiological tests.

(ii) (a) The applicant shall provide adequate space having regard to the nature and number of samples of drugs proposed to be tested:

Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate:

Provided further that separate section shall be provided for (i) Chemistry, (ii) Pharmacognosy, (iii) Ayurveda, Siddha and Unani, (iv) Microbiology, (v) Sample Room, (vi) Office-cum-Record Room, with proper partitions and minimum required area is 800 sq. ft.

1 [(b) The applicant shall provide a list of persons who may be employed with him as experts, such as Chemist, Botanist and expert in Ayurveda/Siddha/Unani or Pharmacist who shall possess a degree in Chemistry, Botany, Ayurveda/Siddha/Unani/Bachelor in Pharmacy from a recognized University or equivalent, with experience for 2 years for carrying out tests or analysis as per the Ayurvedic, Siddha and Unani Pharmacopoeias].

The applicant shall provide adequate equipment essential for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as per pharmacopoeial standards or other available standards.

1. Subs. by G.S.R. 674 (E), dt. 10-11-2005.

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List of equipment recommended is given below:

Chemistry Section

1. Alcohol determination apparatus complete set.

2. volatile oil determination apparatus.

3. Boiling point determination apparatus.

4. Melting point determination apparatus.

5. Refractometer.

6. Polarimeter.

7. Viscometer (Ostwalds, Redwood Viscometer).

8. Tablet disintegration apparatus.

9. Moisture determination apparatus (IC filtrator).

10. U.V.Spectro-photometer.

11. Muffle furnace.

12. Electronic Balance.

13. Hot air oven(s) different range of temperature/vacuum oven.

14. Refrigerator.

15. Glass distillation apparatus/plant.

16. Water supply demineralised exchange equipment/distillation equipment.

17. Air conditioner.

18. LPG Gas cylinder with burners.

19. Water bath (temperature controlled).

20. Heating mantle(4) or as required.

21. TLC apparatus with all accessories.

22. Sieves 10 to 120 with sieve shaker.

23. Centrifuge machine.

24. Dehumidifier.

25. pH meter.

26. G.L.C. with F.I. detector.

27. Silica crucible.

28. Tablet friability tester.

29. Tablet dissolution tester.

30. Other related equipment, reagents, glasswares etc. Pharmacognosy Section

1. Microscope binocular.

2. Dissecting Microscope.

3. Microtome.

4. Chemical balance.

5. Microslide cabinet.

6. Aluminium slide trays.

7. Hot air oven.

8. Occular Micrometer.

9. Stage Micrometer.

10. Camera Lucida Prism type and mirror type.

11. Hot plates.

12. Refrigerator.

13. LPG Cylinder with burners.

14. Other related equipments, reagents, glasswares etc.

Note: Instuments like HPLC, HPTLC, Atomic Absorption spectrophotometer could be arranged by tie up with other laboratories.

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Drugs and Cosmetics Rules 1945 Microbiology section

1. Laminar air flow bench (L.A.F.)

2. B.O.D. Incubator.

3. Plain Incubator.

4. Serological water bath.

5. Oven.

6. Autoclave/sterilizer.

7. Microscope (high power).

8. Colony counter.

9. Other related equipment and reagents. (3). The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of Ayurvedic, Siddha and Unani drugs intended to be tested which shall be adequate in the opinion of the approving authority.

(4) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity, purity, quality and strength shall be carried out under the active direction of one of the experts stated in clause (b) of sub-rule (2) who shall be the person-in-charge of testing and shall be held responsible for the reports of test issued by the applicant.

(5) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualifications and experience of testing are adequate as stated in clause (b) of sub-rule (2).

(6) The applicant shall provide books of standards recognized under the provisions of the Act and the rules made thereunder and such books of reference as may be required in connection with the testing or analysis of the products for the testing of which approval is applied for.

(7) The applicant shall provide list of standard Ayurvedic, Siddha and Unani drugs (Reference samples) recognized under the provisions of the Act and rules made thereunder and such reference samples kept in the laboratory may be required in connection with the testing or analysis of the products of which approval is applied for.

160C. Duration of approval. - An approval granted in Form 48 or renewed in Form 49 unless sooner suspended or withdrawn, shall be valid for a period of three years from the date on which it is granted or renewed:

Provided that if an application for the renewal of an approval in Form 40 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional inspection fee, the approval shall continue to be in force until orders to the contrary are passed on the application and approval shall be deemed to have expired if the application for renewal is not made within six months of expiry.

160D. Conditions of approval.-An approval in Form 48 shall be subject to the following conditions, namely: -

I. The Institution granted approval under this Part (hereinafter referred to as the approved laboratory) shall provide and maintain adequate staff and adequate premises and equipment as specified in rule 160-B.

II. The approved laboratory shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.

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Drugs and Cosmetics Rules 1945

III. The approved laboratory shall maintain records of tests for identity, purity, quality and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which date of expiry is assigned; for a period of two years from such date of expiry and in the case of other substances, for a period of three years.

IV. The approved laboratory shall allow the Inspector appointed under this Act to enter with or without prior notice the premises where testing is carried out and to inspect the premises and the equipment used for test and the testing procedures employed. The laboratory shall allow the Inspectors to inspect the registers and records maintained under these rules and shall supply to such Inspectors such information as they may require for the purpose of ascertaining whether the provisions of the Act and rules made thereunder have been observed.

V. The approved laboratory shall from time to time report to the approving authority any changes in the person-in-charge of testing of Ayurvedic, Siddha and Unani drugs or the expert staff responsible for testing, as the case may be, and any material alterations in the premises or changes in the equipment used for the purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval.

VI. The approved laboratory shall furnish reports of the results of tests or analysis in Form 50.

VII. In case any sample of Ayurvedic, Siddha and Unani drug is found on test to be not of standard quality, the approved laboratory shall furnish to the approving authority and the licensing authority of the State where the manufacturer and/or sender of the Ayurvedic, Siddha and Unani drugs is located, a copy of the test report of the sample with the protocols of tests applied.

VIII. The approved laboratory shall comply with the provisions of the Act and rules made thereunder and with such further requirements, if any, as may be specified in the rules made from time to time under Chapter IV-A of the Act of which the approving authority has given the approved laboratory not less than four months' notice.

IX. The approved laboratory shall maintain an inspection book to enable the Inspector to record his impression or defects noticed.

160-E. Inspection before grant of approval.— Before an approval in Form 48 is granted, the approving authority shall cause the laboratory at which the testing of Ayurvedic, Siddha and Unani drugs, as the case may be, is proposed to be carried out to be inspected jointly by the Inspectors appointed or designated by the Central Government and State Government for this purpose, who shall examine the premises and the equipment intended to be used for testing of drugs and verify into the professional qualifications of the expert staff who are or may be employed by the laboratory.

160F. Report of inspection.— The Inspectors appointed by the Central Government as stated in Rule 160-E shall forward to the approving authority a detailed report of the results of the inspection.

160G. Procedure of approving authority. - (1) If the approving authority after such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act have been observed, it shall grant approval in Form 48.

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Drugs and Cosmetics Rules 1945

(2) If the approving authority is not satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which shall be satisfied before approval could be granted.

160H. Application after rejection. - If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of two thousand rupees, the approving authority may, if, after causing a further inspection to be made and after being satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 48.

160-I. Renewal. - On an application being made for renewal, the approving authority shall, after causing an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act have been complied with, shall issue a certificate of renewal in Form 49.

160J. Withdrawal and suspension of approvals. - (1) The approving authority may, after giving the approved laboratory an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, withdraw an approval granted under this Part or suspend it for such period as it thinks fit either wholly or in respect of testing of some of the categories of Ayurvedic, Siddha and Unani drugs to which it relates, if in his opinion the approved laboratory had failed to comply with any of the conditions of the approval or with any provision of the Act or the rules made thereunder.

(2) Any approved laboratory, whose approval has been suspended or withdrawn, may, within three months of the date of the order of suspension or withdrawal, appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by the Department of Indian Systems of Medicine & Homoeopathy, Government of India in this behalf and notified in the Official Gazette.]

1 [PART XVII

2 [LABELLING, PACKING AND LIMIT OF ALCOHOL IN]

AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

161.²[Labelling, packing and limit of alcohol.]—(1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients³[with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are] used in the manufacture of the preparation together with quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule to the Act³[and in respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all ingredients with the botanical names of plant based ingredients along with part(s) and form of ingredients, in which, these are used in the formulation, with their quantity]:

Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with packing and reference be made to this effect on the label.

(2) The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E (1), be labelled conspicuously with the words 'Caution: To be taken under medical supervision' both in English and Hindi language.

1. Ins. by notification F.1-23/6, dt. 2.2.1970. 3. Ins. by G.S.R. 844(E), dt. 26.11.2012

2. Subs. by G.S.R. 904(E), dt. 2.11.1992.

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(3) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Ayurvedic (including Siddha) or Unani drug²[Patent or Proprietary Ayurveda, Siddha or Unani drugs] and on any other covering in which the container is packed', namely−

(i) The name of the drug.³[For Ayurveda, Siddha or Unani drugs] this purpose the name shall be the same as mentioned in the authoritative books included in the First Schedule of the Act.

(ii) A correct statement of the net content in terms of weight, measure or number as the case may be. The weight and volume shall be expressed in metric system.

(iii) The name and address of the manufacturer.

(iv) The number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words 'Manufacturing Licence Number' or 'Mfg. Lic. No.' or 'M.L.'.

(v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words "Batch No." or "Batch" or "Lot Number" or "Lot No." or "Lot" or any distinguishing prefix.

(vi) The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.

(vii) The words "Ayurvedic medicine" or "Siddha medicine" or "Unani medicine" as the case may be.

(viii) The words "FOR EXTERNAL USE ONLY" if the medicine is for external application.

(ix) Every drug intended for distribution to the medical profession, as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words "Physicians sample. Not to be sold" which shall be over-printed.

1 [(x)(a) Preparation (Asavas) with high content of alcohol as base Name of the drug Maximum size of packing

(i) Karpur Asava 15 ml

(ii) Ahiphenasava 15 ml

(iii) Margamadasava 15 ml (ix)(b) Preparations containing self-generated alcohol Name of the drug Maximum content of alcohol Maximum (Ethyl alcohol v/v) size of

packing

(i) Mritsanjivani Sura 16 per cent 30 ml.

(ii) Mahadrakshasava 16 per cent 120 ml.]

1. Subs. by G.S.R. 904 (E), dt. 2-11-1992.

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(4) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper case or other covering used solely for the purpose of packing, transport or delivery.

1 [161A. Exemption in labeling and packing, provisions for export of Ayurvedic (including Siddha) and Unani drugs.- (1) Labels and packages or containers of Ayurvedic, Siddha and Unani drugs for export may be adopted to meet the specific requirements of the law of the country to which the said drug is to be exported, but the following particulars shall appear in conspicuous position on the container in which drug is packed and on every other covering in which that container is packed, namely :

(a) Name of the Ayurvedic, Siddha and Unani drug (Single or compound formulations;

(b) the name, address of the manufacturer and the number of licence under which the drug has been manufactured;

(c) batch or lot number;

(d) date of manufacture, along with the date for "Best for use before";

(e) main ingredients, if required by the importing country;

(f) for export:

Provided that where Ayurvedic, Siddha and Unani Single or compound drug not classified under the First Schedule or Schedule E-(I), is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in rule 152.

(2) the provisions of Rule 161 shall not apply to a medicine made up "ready for treatment", whether after, or without, alteration, which is supplied on the prescription of a registered medical practitioner if the medicine is labeled with the following particulars, namely:-

(a) the name and address of the suppliers;

(b) the words "For External Use Only", if the medicine is for external application.]

2 [161B. 1. The date of expiry of Ayurveda, Siddha and Unani medicines shall be conspicuously displayed on the label of container or package of an Ayurvedic, Siddhas and Unani medicines, and after the said date of expiry, these medicines shall not be in circulation.

2. The Shelf-life i.e. for Ayurveda, Siddha and Unani medicines shall be as follows:-

(i) Shelf life or date of expiry for Ayurvedic medicines.

1. Ins. by G.S.R. 787 (E), dt. 17-10-2000.

2. Ins. by G.S.R. 764 (E), dt. 15-10-2009.

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Note 1. Item at Sr. No.4, 5, 19, 20, 22, 23 have very long shelf life and they became more efficacious with the passage of time and period of ten years shall be mandatory for keeping the records of such items.

Note 2. Bhasmas at Sr. No. 23, start solidifying after five years and they need one or two 'Puta'again before using in the dosage form.

(ii) Shelf life or date of expiry for Siddha Medicines

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Note. * Items at Sr. No.1, 3, 4, 5, 6, 22 have very long shelf life and they became more efficacious with the passage of time and period of ten years shall be mandatory for keeping the records of such items.

(iii) Shelf life or date of expiry for Unani System of Medicines

Shelf life and date ofexpiry with effect Sl. No. Name of the Group of Medicine from the date of manufacture

1. Habb (Pills) 3 years

2. Qurs (Tablets) 3 years

3. Majoon/Dawa 3 years

4. Khamira 3 years

5. Itrifal 3 years

6. Tiryaq 3 years

7. Laooq 2 years

8. Laboob 2 years

9. Halwa 2 years

10. Mufarreh/Yaqooti 2 years

11. Burood/Surma/Kohal 3 years

12. Kushta 5 years

13. Raughaniyat 3 years

14. Marham/Zimad/Qairooti 3 years

15. Ayarij/Sufoof 2 years

16. Safoof (Namak wala/containing salt) 1 year

17. Sharbat/Sikanjabeen 3 years

18. Jawarish 3 years

19. Capsule 3 years

20. Arq 1 year

21 Qutoor 1 year

22. Nabeez 5 years

23. Murabba 1 year

24. Tila 2 years]

1 [PART XVIII

GOVERNMENT ANALYSTS AND INSPECTORS

FOR AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

162. Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs—Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs-

1. Ins. by notification F.1-23/6, dt. 2-2-1970.

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(i) to inspect not less than twice a year, all premises licensed for manufacture of Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy himself that the conditions of the licence and the provisions of the Act and the rules made thereunder are being observed;

(ii) to send forthwith to the controlling authority after each inspection a detailed report indicating whether or not the conditions of the licence and the provisions of the Act and the rules made thereunder are being observed;

(iii) to take samples of the drugs manufactured on the premises and send them for test or analysis in accordance with these rules;

(iv) to institute prosecutions in respect of violation of the Act and the Rules made thereunder.

1 [162A. Qualifications of the State Drug Licensing Authority for Licensing of Ayurvdeda , Siddha and Unani drugs− (a) The Ayurvedic/ Siddha/ Unani qualifications as per Schedule II of the Indian Medicine Central Council Act, 1970 (84 of 1970)/ B Pharma (Ayurveda) of a recognized University.

(b) At least 5 years experience in the Ayurveda/ Siddha/ Unani drug manufacturing or testing of Ayurvedic, Siddha and Unani drugs or enforcement of provisions of Chapter IVA of the Drugs and Cosmetics Act,1940 and Rules made thereunder or teaching/ research on clinical practice of Ayurveda/ Siddha/ Unani System.]

163. Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst—(1) Sample for test or analysis shall be sent to the Government Analyst by registered post or by hand in a sealed package, enclosed together with a memorandum in Form 18-A in an outer cover addressed to the Government Analyst.

(2) The package as well as the outer cover shall be marked with a distinguishing number.

(3) A copy of the memorandum and a specimen impression of the seal used to seal the package shall be sent by registered post or by hand to the Government Analyst.

(4) On receipt of the package from an Inspector, the Government Analyst or an Officer authorised by him in writing in this behalf shall open the package and shall also record the conditions of the seals on the package.

(5) After the test or analysis has been completed, one copy of the results of the test or analysis shall be supplied forthwith to the sender in Form 13-A. A copy of the result in Form 13A shall also be sent simultaneously to the Controlling Authority and to the Drugs Controller, India.

2 [PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINES TO FUNCTION

AS CENTRAL DRUGS LABORATORY FOR THE PURPOSE OF TESTING OR

ANALYSIS OF AYURVEDA, SIDDHA AND UNANI DRUGS

163.A Functions - The Pharmacopoeial Laboratory for Indian Medicine at Ghaziabad shall function as a Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha and Unani Drugs.

Its functions shall be:-

(1) to develop Pharmacopoeial standards and draft monographs and amendments alongwith standardized methods for the Ayurvedic, Siddha, Unani drugs;

(2) to act as Central Appellate Drug Laboratory for testing of Ayurveda, Siddha and Unani drugs,

(3) to analyse or test such samples of Ayurvedic, Siddha, Unani drugs as may be sent to it under sub-section (2) of section 11, or under sub-section (4) or section 25, of the Act;

(4) to maintain reference museum and herbarium for the drugs used in Ayurveda, Siddha and Unani (ASU) system.

(5) to run a training centre for quality control methods in the Ayurveda, Siddha or Unani systems of medicines;

(6) to carry out such other duties as may be entrusted to it by the Government of India.

1. Ins. by G.S.R. 76 (E), dt. 3.2.2003.

2. Ins. by G.S.R. 352 (E), dt. 1.6.2006.

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163B. The functions of the Central Drug Laboratory in respect of Ayurvedic, Siddha and Unani drugs shall be carried out at the Pharmacopoeial Laboratory for Ayurvedic, Siddha and Unani medicine, Ghaziabad, (Uttar Pradesh) and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said laboratory.

163C. Despatch of samples for test or analysis - (1) Samples for testing or analysis of Ayurveda, Siddha and Unani drugs under Sub-section (2) of Section 11 or sub-section (1) of section 25 and section 33-H of the Act shall be sent by registered post in a sealed packet, enclosed with a memorandum in Form 1 A, specified in Schedule A, in an outer cover addressed to the Director, Pharmacopoeial Laboratory for Indian Medicine.

(2) The packet as well as the outer cover, shall be marked with a distinguished number.

(3) A copy of the memorandum in Form 1A and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director, Pharmacopoeial Laboratory for Indian Medicine.

163D. Recording of condition of seals - On receipt of the packet, it shall be opened by an officer authorized in writing on that behalf by the Director, Pharmacopoeial laboratory for Indian Medicine, who shall record the condition of the seal on the packet.

163E. Report of result of test or analysis - After test or analysis, the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2A of as specified in the said schedule.

163F. Fees - The fees for test and analysis shall be as specified in Schedule B-1

163G. Signature on certificates - Certificates issued under these rules by the Pharmacopoeial Laboratory for Indian Medicine, shall be signed by the Director or by an officer authorized by the Central Government to sign such certificates.

164. Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs.—The method of test or analysis to be employed in relation to an Ayurvedic (including Siddha) or Unani drug shall be such as may be specified in the Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such pharmacopoeias are available or if no tests are specified in such pharmacopoeias, such tests as the Government Analyst may employ, such tests being scientifically established to determine whether the drug contains the ingredients as stated on the label.

165. Qualifications of Government Analyst. —A person who is appointed a Government Analyst under section 33 F of the Act shall be a person possessing the qualifications prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani System, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognized by the Central or State Government, as the case may be, for this purpose and has had not less than three years' post graduate experience in the analysis of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) a Chemical Examiner to Government, or (iii) the Head of an institution specially approved for the purpose by the appointing authority.

166. Duties of Government Analyst- (1) The Government Analyst shall analyze or test or cause to be analyzed or tested such samples of Ayurvedic (including Siddha) or Unani drugs as may be sent to him by Inspectors or any other persons or authority authorised by the Central Government or State Government under the provisions of Chapter IV A of the Act and shall furnish reports of the results of test or analysis in accordance with these rules.

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(2) A Government Analyst appointed under section 33F shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publications at the discretion of the Government.]

1 [167. Qualifications of Inspector.-A person who is appointed an Inspector under section 33G shall be a person who—

(a) has the qualifications laid down under rule 49 and shall have undergone practical training in the manufacture of Ayurvedic (including Siddha) or Unani drug, as the case may be; or

(b) has a degree in Ayurvedic or Siddha or Unani System or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or State Government or a Statutory Faculty, Council or Board of Indian Systems of Medicine recognized by the Central Government or the State Government for this purpose; or

(c) has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be, granted by a State Government or an Institution recognized by the Central Government or a State Government for this purpose.

2 [PART XIX

STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS

168. Standards to be complied with in manufacture for sale or for distribution of Ayurvedic, Siddha and Unani Drugs.-

Class of Drugs Standards to be complied with

1.³[* * *] drugs included in The standards for identity, purity and strength as Ayurvedic Pharmacopoeia. given in the editions of Ayurvedic Pharmacopoeia of India for the time being in

force.

2. Asavas and Arishtas The upper limit of alcohol as self generated alcohol should not exceed 12% v/v excepting

those that are otherwise notified by the Central Government from time to time.]

1. Amended by G.S.R. 376 (E), dt. 20.7.1978.

2. Ins. by G.S.R. 519(E), dt. 26.6.1995.

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1 [169. Permitted Excipients.- Permitted Excipients along with their standards i.e. additives, preservatives, antioxidants, flavouring agents, chelating agents etc. permitted in the Indian Pharmacopoeia (IP), Prevention of Food Adulteration Act, 1954 and Bureau of Indian Standard Act, 1986 are permitted for use in Ayurveda, Siddha and Unani drugs with the following conditions, namely:-

1. The above excipients shall be used in the permissible limits as prescribed in the Indian Pharmacopoeia/ Prevention of Food Adulteration Act, 1954/ Food Product Order/ Bureau of Indian Standard Act, 1986 and they shall comply with the respective quality specifications, not exceeding any specified limits of usage therein, and except Hydrogenated vegetable oil.

2. Only Natural coloring agents as permitted under rule 26 of Prevention of Food Adulteration Rules, 1955 will be used for Ayurveda, Siddha and Unani drugs and additionally, colors permitted under Rule 127 of the Drugs and Cosmetics Rules, 1945 shall be used for Proprietary Ayurveda, Siddha and Unani drugs as defined in subclause (i) of clause (h) of section 3 of Drugs and Cosmetics Act, 1940, not exceeding any specified limits of usage therein.

3. Preservatives and Coloring agents shall be mentioned on the label for the information of the consumer as required under rule 161 of the Drugs and Cosmetics Rules, 1945.

4. Additives used in various processes and in formulating dosage forms shall be mentioned clearly with quantities used, in the application for licenses and the record for the same shall be maintained by the manufacturers.

5. Manufacturers shall be responsible to ensure rationality, safety and quantity used of various excipients in the formulation.

6. If any excipients or additive or preservative etc. referred in Indian Pharmacopoeia/ Prevention of Food Adulteration Act, 1954/ Food Product Order/ Bureau of Indian Standard Act, 1986 is deleted at a particular point of time, this will also be deleted simultaneously for the use in Ayurveda, Siddha and Unani drugs.

7. Following artificial sweeteners as per maximum limit indicated below may be used in various dosage forms of Ayurveda, Siddha, Unani Proprietary Medicines:-

Artificial sweeteners may be used only in proprietary ASU products and the label of such products should carry a statutory warning stating the name and quantity of the artificial sweetener used.

The recommended Acceptable Daily Intake (ADI) of these sweeteners as laid down by US FDA is as follows:

Sr. No. Sucralose Aspartame Saccharin Acesulfame K

1 5 mg/kg body 40 mg/kg body 5 mg/kg body 15 mg/kg body weight weight weight weight

One third of the above ADI would be permissible for use in Ayurveda, Siddha, Unani Patent and Proprietary Drugs.

8. Any previous notification issued by the Department of AYUSH regarding use of excipients / additives or preservatives in Ayurveda, Siddha and Unani medicines stands superseded.]

1. Subs. by G.S.R. 755 (E), dt. 23.10.2008. Earlier ins. by G.S.R. 285 (E), dt. 11.5.2005.

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SCHEDULE A

FORM 1

(See rule 4)

Memorandum to the Central Drugs Laboratory

Serial Number .................................. To the Director, Central Drugs Laboratory ...................................................... From......................................

I send herewith, under the provisions of section 25 (4) of the Drugs and Cosmetics Act, 1940, sample(s) of a drug purporting to be ....................for test or analysis and request that a report of the result of the test or analysis may be supplied to this Court.

(2) The distinguishing number on the packet is ............................................

(3) Particulars of offence alleged ...................................................................

(4) Matter on which opinion is required .......................................

(5) A fee of Rs ................. has been deposited in Court. Date .................... …….............

Magistrate

1 [FORM 1

(See rule 163C)

Memorandum to the Pharmacopoeial Laboratory for Indian Medicine (PLIM)

From .................................. (Full name, Designation and Postal address of the sender) Serial No...................................... To the Director,

Pharmacopoeial Laboratory for Indian Medicine, I send herewith, under the provisions of section 11(2)/section 25(4) and section 33H of the Drugs and Cosmetics Act, 1940, sample(s) of a drug purporting to be ....................for test or analysis and request that a report of the result of the test or analysis may be supplied to this Court.

(2) The distinguishing number on the packet is ............................................

(3) Particulars of offence alleged ...................................................................

(4) Matter on which opinion is required .......................................

(5) A fee of Rs ................. has been deposited in Court. Date .................... ……….…............. Magistrate/Authorized Signatory]

1. Ins. by G.S.R. 352(E) , dt. 1.6.2006.

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Drugs and Cosmetics Rules 1945

FORM 2

(See rule 6)

Certificate of test or analysis by the Central Drugs Laboratory

Certified that the sample bearing number ....................................... ……………….. purporting to be a sample of. .................................................. received on .................... with memorandum No ................................................................ dated.................................... from ............................................... has been tested / analysed and that t he result of s uch t e s t / analysis is as stated below.

2. The condition of the seals on the packet on receipt was as follows: — *3. In the opinion of the undersigned the sample is of standard quality is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given below:-

Director

Date……………… Central Drugs Laboratory or other authorised officer Details of results of test or analysis with protocols of test applied Director

Date..................Central Drugs Laboratory or other authorised officer * If opinion is required on any other matter, the paragraph should be suitably amended.

1 [FORM 2A

(See rule 163E)

Certificate of test or analysis from the Pharmacopoeial Laboratory for Indian Medicine or Governmen Analyst

Certified that the sample bearing number ....................................... ……………….. purporting to be a sample of. .................................................. received on .................... with memorandum No ................................................................ dated.................................... from ............................................... has been tested / analysed and that t he result of s uch t e s t / analysis is as stated below.

2. The condition of the seals on the packet on receipt was as follows: — *3. In the opinion of the undersigned the sample is of standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given below. Or

In the opinion of the undersigned the sample is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given below.

"Note: *delete whichever is not applicable."

(Signature of the Analyst Person-in-Charge of testing) Date…………….

Place…………….

Name & Designation and Seal…………….

Name and Address of the laboratory ……………]

1. Ins. by G.S.R. 352(E) , dt. 1.6.2006.

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Drugs and Cosmetics Rules 1945

1 FORMS 3-7 (Omitted)

2 [FORM 8

(See rule 24)

Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945

I/We* ......................................................... (full address with telephone number, fax number and e-mail address) hereby apply for a licence to import drugs specified below manufactured by M/s ........................................... (full address with telephone no, fax and e- mail no.).

2. Names of the drugs to be imported:

(1)

(2)

(3)

3. I/We* ..................................................... enclose herewith an undertaking in Form 9 dated …………signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics Rules, 1945.

4. I/We* ................................................... enclose herewith a copy of Registration Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No .....................dated .................. issued through M/s. ............................. (name and full address) ................................valid up to ................................

5 I/We* .................................................... hold a valid wholesale licence for sale or distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and rules made thereunder. A copy of the said licence is enclosed.

6. A fee of ..................has been credited to Government under the Head of Account "0210- Medical and Public Health, 04-Public Health, 104-Fees and Fines" under the Drugs and Cosmetics Rules, 1945 - Central vide Challan No ......................... dated ................(attached in original)

Signature .......................

Name..............................

Designation ...................

Seal/Stamp of Manufacturer's agent in India.

Place: ......

Date: ...........

*Delete whichever is not applicable.]

1. Forms 3 to 7 omitted by Notfn. No. F. 1-16/57-D, dt. 15-6-1957.

2. Subs. by G.S.R. 604(E) , dt. 24.8.2001.

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1 [FORM 8A

(See rule 24)

Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945

I/We* ............................... (full address with telephone number, fax number and e-mail address) hereby apply for a licence to import drugs specified below manufactured by M/s ....................................... (full address with telephone no, fax and e-mail no.).

2. Name of the drugs to be imported:

(1)

(2)

(3)

3. I/We* ........................................ enclose herewith an undertaking in Form 9 dated……………signed by t h e manufacturer a s required by rule 24 of the Drugs a nd Cosmetics Rules, 1945.

4. I/We* ........................................... enclose herewith a copy of Registration Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No dated issued through M/s.

................................................ (name and full address) ............................ …………… valid upto………………………………

5. I/We* ............................. hold a valid wholesale licence for sale or distribution of drug or licence to manufacture drugs, under the provisions of the Act and rules made thereunder. A copy of the said licence is enclosed.

6. A fee of .......................... has been credited to Government under the Head of Account

"0210 - Medical and Public Health, 04- Public Health, 104- Fees and Fines" under the Drugs and Cosmetics Rules 1945 - Central vide Challan No ....................... dated ................. (attached in original).

Signature .................................

Name .....................................

Designation .............................

Seal/Stamp of Manufacturer's agent in India.]

Place: ......

Date: ...........

*Delete whichever is not applicable.

1. Subs. by G.S.R. 604(E), dt.24.8.2001.

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Drugs and Cosmetics Rules 1945

FORM 9

(See rule 24)

Form of undertaking to accompany an application for an import licence

Whereas .............................. of............................. intends to apply for a licence under the Drugs and Cosmetics Rules, 1945, for the import into India, of the drugs specified below manufactured by us, we……………………………of…………………………..hereby give

this undertaking that for the duration of the said licence—

(1) the said applicant shall be our agent for the import of drugs into India;

(2) we shall comply with the conditions imposed on a licence by¹[rules 74 and 78] of the Drugs and Cosmetics Rules, 1945;

(3)we declare that we are carrying on the manufacture of the drugs mentioned in this undertaking at the premises specified below, and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories;

(4) we shall comply with the provisions of Part IX of the Drugs and Cosmetics Rules, 1945;

(5) every drug manufactured by us for import under licence into India shall as regards strength, quality and purity conform with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945;

(6) we shall comply with such further requirements, if any, as may be specified by Rules, by the Central Government under the Act and of which the licensing authority has given to the licensee not less than four months' notice.

Names of drugs and classes of drugs

Particulars of premises where manufacture is carried on.

Date.......................²[Signature, Name, Designation Seal/Stamp of manufacturer or on behalf of the manufacturer.]

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Drugs and Cosmetics Rules 1945

.

1 [FORM 10

(See rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945

Licence Number .............. Date... …………..

1. ........................................................................................ (Name and full address of the importer) is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by M/s .................................................. (name and full address) and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from ........................... to ............. unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported. Place : ……….

Date : ………. Licensing Authority Seal/Stamp

Conditions of Licence.

1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, and the original licence shall be produced, whenever required.

2. Each batch of drug imported into India shall be accompanied with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and the date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer in India along with the registration holder and his authorised agent.

4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution.]

1. Subs. by G.S.R. 604(E) ,dt. 24.8.2001.

204

Drugs and Cosmetics Rules 1945

1 [FORM 10A

(See rules 23 and 27)

Licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945

Licence Number ............................. Date……………………. ...............................................................................................................(Name and full address of the importer) is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by M/s ...................................... (name and full address) and any other drugs manufactured by the said manufacturer as may from time to

time be endorsed on this licence.

2. This licence shall be in force from ............................. to .......................... unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported. Place:...................... Date: .....................

Licensing Authority Seal/Stamp.

*Delete whichever is not applicable. Conditions of Licence

1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, and the original licence shall be produced, whenever required.

2. Each batch of drug imported into India shall be accompanied with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and the date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer in India along with the registration holder and his authorised agent.

4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution.]

1. Subs. by G.S.R. 604(E), dt. 24.8.2001.

205

Drugs and Cosmetics Rules 1945

FORM 11

(See rule 33)

Licence to import drugs for the purposes of examination, test or analysis

1 ………………of .......................... is hereby licensed to import from ................................ the drugs specified below for the purposes of examination, test or analysis at

...............................or in such other places as the licensing authority may from time to time authorise.