Drugs and Cosmetics Act, 19401
| [Act 23 of 1940 as amended up to Act 26 of 2008] | [10th April, 1940] |
An Act to regulate the import, manufacture, distribution and sale of drugs 2[and cosmetics]
Whereas it is expedient to regulate the 3[import, manufacture, distribution and sale] of drugs 4[and cosmetics];
And whereas the Legislatures 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:-
__________________________
1 For Statement of Objects and Reasons, see Gaz. of India, 1940, Pt. V, p. 34, for the Report of the Select Committee, see ibid., p. 143.
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 Ins. by Act 21 of 1962, S. 2 (w.e.f. 27-7-1964).
Statement of Objects and Reasons of Amending Act 68 of 1982. 1-The Drugs and Cosmetics Act, 1940 regulates the import into, manufacture, distribution and sale of drugs and cosmetics in the country. The problems of adulteration of drugs and also of production of spurious and substandard drugs are posing serious threat to the health of the community. It is, therefore, considered necessary to amend the Drugs and Cosmetics Act, so as to impose more stringent penalties on the antisocial elements indulging in the manufacture or sale of adulterated or spurious drugs or drugs not of standard quality which are likely to cause death or grievous hurt to the user. This opportunity is also being availed of to incorporate certain other provisions on the other aspects of effective control on the manufacture, distribution, sale of drugs and cosmetics on the basis of experience gained in the working of the Act.
2. Some of the important proposals envisaged are set out below:-
(1)(a) Widening of the definition of the expression ‘cosmetics’ so as to bring within its scope ‘toilet soaps’ in order to exercise control over such soaps which may contain harmful ingredients like hexachlorophene [vide clause 3(c)];
(b)The definition of the expression ‘drugs’ to be expanded to enable control being exercised over the components of drugs including empty gelatine capsules and also devices which are intended for internal or external use in the diagnosis or treatment of diseases in human beings or animals [vide clause 3(d)];
(c)Widening of the scope of the expression ‘patent or proprietary medicine’ so as to include patent or proprietary medicines which relate to Ayurveda, Siddha or Unani Tibb systems of medicines but not including such medicines as are administered by parenteral (i.e. by means of injections) route [vide clause 3(f)].
(2) Incorporation of a new provision for the purpose of defining certain terms like ‘spurious drugs’ and ‘spurious cosmetics’ and making of suitable consequential amendments in the definitions of other expressions like ‘misbranded drugs’, ‘adulterated drugs’ and ‘misbranded cosmetics’. Analogous provisions of a like nature are also to be included in respect of drugs relating to Ayurveda, Siddha or Unani Tibb systems of medicines [vide clauses 6, 13 and 31].
(3) New provisions to be incorporated to empower the Central Government to prohibit import or manufacture of drugs and cosmetics in the public interest where that Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or where the drug does not have any therapeutic justification [vide clauses 8 and 21].
(4) Insertion of a mandatory provision so as to make it obligatory for any person who is a holder of a licence to maintain such records, registers and other documents as may be prescribed and to produce them to the authority concerned if and when required [vide clause 15].
(5) Provision to empower the Inspector to 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 the Act is being committed [vide clause 19].
(6) Enhancement of the quantum of punishment for offences relating to the manufacture or sale of adulterated, spurious drugs or drugs not of a standard quality which are likely to cause death or grievous hurt to the user. Penalties provided in respect of other offences are to be revised on a more rational basis.
(a) The proposed scale of punishment in respect of the first offence shall be as set out below [vide clause 22]:
(i) imprisonment for not less that five years which may extend to life and with fine of not less than rupees ten thousand for the manufacture and sale of adulterated or spurious drugs or drugs not of standard quality which are likely to cause death or harm on the patient's body as would amount to grievous hurt;
(ii) imprisonment for not less than one year which may extend to three years and fine of not less than rupees five thousand for manufacture and sale of any adulterated drug or manufacture and sale of drugs without a valid licence;
(iii) imprisonment for three years which may extend to five years and with fine of not less than rupees five thousand for manufacture or sale of spurious drugs;
(iv) imprisonment for other offences shall be not less than one year which may extend to two years and with fine.
(b) The proposed scale of punishment for subsequent offences shall be as set out below [vide clause 25]-
(i) imprisonment for not less than two years which may extend to six years and with fine of not less than rupees ten thousand for manufacture and sale of any adulterated drug or manufacture and sale of drugs without a valid licence;
(ii) imprisonment for not less than six years which may extend to ten years and with fine of not less than rupees ten thousand for manufacture and sale of a spurious drug;
(iii) imprisonment for a term for not less than two years which may extend to four years and with fine of not less than rupees one thousand or with both for other offences.
(7) Provision to be made in Section 33-C to give representations to experts in the Ayurvedic, Siddha and Unani systems of medicines on the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board [vide clause 30].
(8) Another proposal relates to the constitution of an Advisory Committee to be called 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 intended to secure uniformity throughout India in the administration of the Act. The Committee shall consist of two persons to be nominated by the Central Government and one each by the State Government [vide clause 31].
(9) Punishments for manufacture, sale, etc. of Ayurvedic, Siddha or Unani drugs in contravention of the provisions of the Act are sought to be enhanced [vide clause 33].
(a) The proposed scale of punishments for the first offence shall be as set out below-
(i) imprisonment up to one year or with fine of not less than rupees one thousand for the manufacture of adulterated, Ayurvedic, Siddha and Unani drugs or its manufacture without a valid licence;
(ii) imprisonment for one year which may extend to three years and fine of not less than rupees five thousand for the manufacture of spurious, Ayurvedic, Siddha and Unani drugs;
(iii) imprisonment for three months and fine of not less than rupees five thousand for other offences.
(b) The proposed scale of punishment for subsequent offences shall be as set out below-
(i) imprisonment for a term which may extend to two years and with fine of not less than rupees two thousand for offences of manufacturing, sale or distribution of any Ayurvedic, Siddha or Unani drug;
(ii) imprisonment for two years which may extend to six years and with fine of not less than rupees five thousand for manufacturing of any spurious Ayurvedic, Siddha or Unani drug or sale thereof;
(iii) imprisonment for six months and with fine of rupees one thousand for other offences.
(10) A new provision to be made to provide for summary trial in case of offences where the penalty is not more than three years' imprisonment [vide clause 39].
3. The Bill seeks to achieve the above objects. The above apart, the other amendments sought to be effected are of a general or consequential nature.
1 Amending Act 68 of 1982 came into force on Feb. 1, 1983, vide Noti. No. X-11012/1/81-DMS & PFA, dt. Jan. 25, 1983.
CHAPTER 1 - INTRODUCTORY
1. Short title, extent and commencement.-(1) This Act may be called the Drugs 1[and Cosmetics] Act, 1940.
(2) It extends to the whole of India 2[***].
(3) It shall come into force at once; but Chapter III shall take effect only from such date 3 as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such date 4 as the State Government may, by like notification, appoint in this behalf:
5[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date after 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.]
1 Ins. by Act 21 of 1962, S. 3 (w.e.f. 27-7-1964).
2 The words "except the State of Jammu and Kashmir" omitted by Act 19 of 1972, S. 2.
3 1st April, 1947; see Noti. No. F. 28(10) (3) 45-H(I), dt. the 2nd Sept., 1946, Gaz. of India, 1946, Pt. I, p. 1349.
Chap. IV came into force in the States of Delhi, Ajmer and Coorg on the 1st April, 1947, see ibid., Chaps. III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1st April, 1953, vide Noti. No. S.R.O. 663, dt. the 30th March, 1953, Gaz. of India, Pt. II, S. 3, p. 451.
Chap. IV came into force in the Union Territory of Dadra and Nagar Haveli w.e.f. 1st Aug., 1968, see Noti. No. ADM/Law/117(74), dt. the 20th July, 1968, Gaz. of India, Pt. II, S. 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.
The Act came into force in the State of Sikkim on Sept. 15, 1984 vide S.O. 767(E), dt. 5-10-1984.
The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government Noti. No. 3358-LSG, dt. the 25th Aug., 1941.
4 1st April, 1947; see Noti. No. F. 28(10) (3) 45-H(I), dt. the 2nd Sept., 1946, Gaz. of India, 1946, Pt. I, p. 1349.
Chap. IV came into force in the States of Delhi, Ajmer and Coorg on the 1st April, 1947, see ibid., Chaps. III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1st April, 1953, vide Noti. No. S.R.O. 663, dt. the 30th March, 1953, Gaz. of India, Pt. II, S. 3, p. 451.
Chap. IV came into force in the Union Territory of Dadra and Nagar Haveli w.e.f. 1st Aug., 1968, see Noti. No. ADM/Law/117(74), dt. the 20th July, 1968, Gaz. of India, Pt. II, S. 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.
The Act came into force in the State of Sikkim on Sept. 15, 1984 vide S.O. 767(E), dt. 5-10-1984.
The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government Noti. No. 3358-LSG, dt. the 25th Aug., 1941.
5 Added by Act 19 of 1964, S. 2.
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,-
1[(a) "Ayurvedic, Siddha or Unani drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 2[disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 3[Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]
4[(aa) "the Board" means-
(i) in relation to Ayurvedic, Siddha or Uanni drug, the 5[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board] constituted under Section 33-C; and
(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted under Section 5;]
6[7[(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 of cosmetic, 8[***];]
9[(b) "drug" includes-
10[(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 body or intended to be used for the destruction of 11[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;]
12[(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;]
13[(c) "Government analyst" means-
(i) in relation to Ayurvedic, Siddha or Unani drug, a Government Analyst appointed by the Central Government or a State Government under Section 33-F; 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;]
14[***]
15[(e) "Inspector" means-
(i) in relation to Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government or a State Government under Section 33-G; and
(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under Section 21;]
16[17[(f) "manufacture" in relation to any drug 18[or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug 19[or cosmetic] with a view to its sale 20[or] distribution but does not include the compounding or dispensing 21[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;]
22[(g)] "to import", with its grammatical variations and cognate expressions means to bring into 23[India];
24[25[(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;]
26[27[(i)] "prescribed" means prescribed by rules made under this Act.]
28[***]
1 Ins. by Act 13 of 1964, S. 2 (w.e.f. 15-9-1964).
2 Subs. by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
3 Subs. by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
4 Original cl. (a) was relettered as cl. (aa) and subs. by S. 2, ibid. (w.e.f. 15-9-1964).
5 Original cl. (a) was relettered as cl. (aa) and subs. by S. 2, ibid. (w.e.f. 15-9-1964), see also S. 42 of Act 68 of 1982 in the Appendix.
6 Ins. as cl. (aa) by Act 21 of 1962, S. 4 (w.e.f. 27-7-1964).
7 Relettered by Act 13 of 1964, S. 2 (w.e.f. 15-9-1964).
8 Words "but does not include soap" omitted by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
9 Subs. by Act 11 of 1955, S. 2, for cl. (b).
10 Subs. by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
11 Subs. by S. 2, ibid., for "vermins" (w.e.f. 15-9-1964).
12 Ins. by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
13 Subs. by S. 32, ibid., for cl. (c) (w.e.f. 15-9-1964).
14 Cl. (d) omitted by Act 19 of 1972, S. 3.
15 Subs. by Act 13 of 1964, S. 2, for cl. (e) (w.e.f. 15-9-1964).
16 Cl. (bbb) ins. by Act 11 of 1955, S. 2.
17 Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, S. 2 (w.e.f. 16-3-1961).
18 Ins. by Act 21 of 1962, S. 4 (w.e.f. 27-7-1964).
19 Ins. by Act 21 of 1962, S. 4 (w.e.f. 27-7-1964).
20 Subs. for "and" by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
21 Subs. by Act 21 of 1962, for "or the packing of any drug".
22 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).
23 Subs. by Act 3 of 1951, S. 3 and Sch., for "the States".
24 Subs. by Act 68 of 1982, S. 3 (w.e.f. 1-2-1983).
25 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).
26 Subs. by Act 11 of 1955, S. 2, for original cl. (e).
27 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).
28 Cl. (f) ins. by the A.O. 1950, omitted by Act 3 of 1951, S. 3 and Sch.
1[3-A. 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.]
1 Ins. by Act 19 of 1972, S. 4.
4. Presumption as to poisonous substances.-Any substance specified as poisonous by rule made under Chapter II or Chapter IV 1[or Chapter IV-A] shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV 40[or Chapter IV-A], as the case may be.
1 Ins. by Act 13 of 1964, S. 3 (w.e.f. 15-9-1964).
CHAPTER 2 - THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY 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.
1[(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 the Indian Veterinary Research Institute, Izatnagar, ex officio;
(vi) the President of the Medical Council of India, ex officio;
(vii) the President of the Pharmacy Council of India, ex officio;
(viii) the Director of the 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;
(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:
2[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.
1 Subs. by Act 13 of 1964, S. 4, for sub-section (2) (w.e.f. 15-9-1964).
2 Subs. by Act 13 of 1964, S. 4, for the proviso (w.e.f. 15-9-1964).
6. The Central Drugs Laboratory.-(1) The Central Government shall, as soon as may be, establish 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 respect of any drug or class of drugs 1[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 Central Drugs Laboratory in respect of such drug or class of drugs 2[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;
3[***]
(d) the procedure for the submission to the said Laboratory 4[under Chapter IV or Chapter IV-A] of samples of drugs 5[or cosmetics] for analysis or test, the forms of the Laboratory's reports thereon and the fees payable in respect of such reports;
(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).
STATE AMENDMENTS
Uttar Pradesh
In Section 6, in sub-section (1) after the existing proviso, the following further proviso shall be added, namely:-
"Provided further that the State Government may, with the prior approval of the Central Government, direct that the functions of the Central Drugs Laboratory and of the Director may be carried out in Uttar Pradesh by such Authority and such officer respectively as may be specified by the State Government by notification in the Official Gazette and any reference in this Act to the Central Drugs Laboratory or the Director shall then be construed as a reference to such Authority or officer, as the case may be." [U.P. Act 47 of 1975, Section 5]
West Bengal
In sub-section (1) of Section 6, after the existing proviso, the following further proviso shall be added, namely:-
"Provided further that the State Government may, with the prior approval of the Central Government, direct that the functions of the Central Drugs Laboratory and the Director may be carried out in West Bengal by such Authority and such officer respectively as may be specified by the State Government by notification in the Official Gazette and any reference in this Act to the Central Drugs Laboratory or the Director shall then be construed to mean such Authority or officer, as the case may be." [W.B. Act 42 of 1973, Section 5]
1 Ins. by Act 21 of 1962, S. 5 (w.e.f. 27-7-1964).
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).
5 Ins. by Act 21 of 1962, S. 5 (w.e.f. 27-7-1964).
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 matter tending to secure uniformity throughout 1[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.
1 Subs. by Act 3 of 1951, S. 3 and Sch., for "the States".
1[7-A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.-Nothing contained in Sections 5 and 7 shall apply to Ayurvedic, Siddha or Unani drugs.]
1 Ins. by Act 13 of 1964, S. 6 (w.e.f. 15-9-1964).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
8. Standards of quality.- 2[(1) For the purposes of this Chapter, the expression "standard quality" means-
(a) in relation to a drug, that the drug complies with the standard set out in 3[the Second Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies 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 otherwise amend 4[the Second Schedule], for the purposes of this Chapter, and thereupon 5[the Second Schedule] shall be deemed to be amended accordingly.
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Subs. by Act 21 of 1962, S. 6, for sub-section (1) (w.e.f. 27-7-1964).
3 Subs. by Act 13 of 1964, S. 7, for "the Schedule" (w.e.f. 15-9-1964).
4 Subs. by Act 13 of 1964, S. 7, for "the Schedule" (w.e.f. 15-9-1964).
5 Subs. by Act 13 of 1964, S. 7, for "the Schedule" (w.e.f. 15-9-1964).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
2[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.]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Subs. by Act 68 of 1982, S. 5 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
2[9-A. 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 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 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Ss. 9-A to 9-D subs. for Ss. 9-A and 9-B by Act 68 of 1982, S. 6 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
9-B. 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 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.
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
9-C. 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.
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
9-D. Spurious cosmetics.-For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-
(a) if it is imported under a 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 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.]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
10. Prohibition of import of certain drugs or cosmetics.-From such 2date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import-
(a) any drug 3[or cosmetic] which is not of standard quality;
4[(b) any misbranded drug or misbranded 5[or spurious] cosmetic;]
6[(bb)any adulterated 7[or spurious] drug;]
(c)any drug 8[or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;
9[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of 10[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;
11[(ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;]
(f) any drug 12[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.
Explanation.- 13[***]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 1st April, 1947, for cls. (a), (b), (c), (e) and (f) and 1st April, 1949, for cl. (d), see Noti. No. 18-12-46-D-I, dt. the 11th Feb., 1947, Gaz. of India, 1947, Pt. I, p. 189 as amended by Noti. No. F-1-2/48-D(1), dt. the 29th Sept., 1948.
1st April, 1953, for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur; vide Noti. No. S.R.O. 666, dt. the 30th March, 1953, Gaz. of India, 1953, Pt. II, S. 3, p. 451.
3 Ins. by Act 21 of 1962, S. 8 (w.e.f. 27-7-1964).
4 Subs. by S. 8, ibid., for cl. (b) (w.e.f. 27-7-1964).
5 Ins. by Act 68 of 1982, S. 7 (w.e.f. 1-2-1983).
6 Ins. by Act 13 of 1964, S. 9 (w.e.f. 15-9-1964).
7 Ins. by Act 68 of 1982, S. 7 (w.e.f. 1-2-1983).
8 Ins. by Act 21 of 1962, S. 8 (w.e.f. 27-7-1964).
9 Subs. by Act 11 of 1955, S. 5 for cl. (d).
10 Subs. by Act 68 of 1982, S. 7 (w.e.f. 1-2-1983).
11 Ins. by Act 21 of 1962, S. 8 (w.e.f. 27-7-1964).
12 Ins. by Act 21 of 1962, S. 8 (w.e.f. 27-7-1964).
13 Omitted by Act 68 of 1982, S. 7 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
2[10-A. 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.]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Ins. by Act 68 of 1982, S. 8 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
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 the Sea Customs Act, 1878 (18 of 1878) 2 shall, subject to the provisions of Section 13 of this Act, apply in respect of drugs 3[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under this Act to perform the duties imposed thereby on a 4[Commissioner of Customs] and other officers of Customs, shall have the same powers in respect of such drugs 5[and cosmetics] as they have for the time being in respect of such goods as aforesaid.
6[(2) Without prejudice to the provisions of sub-section (1), the 7[Commissioner of Customs] or any officer of the Government authorized by the Central Government in this behalf, may detain any imported package which he suspects to contain any drug 8[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 package or sample of any suspected drug 9[or cosmetic] found therein to the Central Drugs Laboratory.]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Now see the Customs Act, 1962.
3 Ins. by Act 21 of 1962, S. 9 (w.e.f. 27-7-1964).
4 Subs. by Act 22 of 1995, S. 83.
5 Ins. by Act 21 of 1962, S. 9 (w.e.f. 27-7-1964).
6 Subs. by Act 11 of 1955, S. 6, for sub-section (2).
7 Subs. by Act 22 of 1995, S. 83.
8 Ins. by Act 21 of 1962, S. 9 (w.e.f. 27-7-1964).
9 Ins. by Act 21 of 1962, S. 9 (w.e.f. 27-7-1964).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
12. Power of Central Government to make rules.-(1) The Central Government may, after consultation with 2[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:
3[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) specify the drugs or classes of drugs 4[or cosmetics or classes of cosmetics] for the import of 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 5[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;]
(b) prescribe the methods of test or analysis to be employed in determining whether a drug 6[or cosmetic] is of standard quality;
(c) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;
7[(cc) prescribe under clause (d) of 8[Section 9-A] the colour or colours which a drug may bear or contain for purposes of colouring;]
(d) specify the diseases or ailments which an imported drug may not purport or claim 9[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 for personal use;
(f) prescribe the places at which drugs 10[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;
(h) regulate the submission by importers, and the securing, of samples of drugs 11[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 drugs 12[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 drugs 13[or cosmetics] detained pending admission;
(j) provide for the exemption, conditionally or otherwise from all or any of the provisions of this Chapter and the rules made thereunder of drugs 14[or cosmetics] imported for the purpose only of transport through, and export from 15[India];
(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs 16[or cosmetics] 17[including the use of packing material which comes into direct contact with the drugs];
(l) regulate the mode of labelling drugs 18[or cosmetics] imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;
(m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import 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;
(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 drugs 19[or cosmetic or class of cosmetics.]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Ins. by Act 68 of 1982, S. 9(a) (w.e.f. 1-2-1983).
3 Ins. by Act 11 of 1955, S. 7, for sub-section (2).
4 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
5 Ins. by Act 68 of 1982, S. 9 (w.e.f. 1-2-1983).
6 Ins. by Act 13 of 1964, S. 10 (w.e.f. 15-9-1964).
7 Ins. by Act 13 of 1964, S. 10 (w.e.f. 15-9-1964).
8 Subs. for "S. 9-B" by Act 68 of 1982, S. 9 (w.e.f. 1-2-1983).
9 Subs. by Act 11 of 1955, S. 7, for "to cure or mitigate".
10 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
11 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
12 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
13 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
14 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
15 Subs. by Act 3 of 1951, S. 3 and Sch., for "the States".
16 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
17 Ins. by Act 68 of 1982, S. 9 (w.e.f. 1-2-1983).
18 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
19 Ins. by Act 21 of 1962, S. 10 (w.e.f. 27-7-1964).
CHAPTER 3 - IMPORT OF DRUGS 1[AND 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 9-A or deemed to be a spurious drug under Section 9-B or any spurious cosmetic referred to in Section 9-D 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 10-A, 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.]
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Subs. by Act 68 of 1982, S. 10 (w.e.f. 1-2-1983).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
14. Confiscation.-Where any offence punishable under Section 13 has been committed, the consignment of the drugs 2[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Ins. by Act 21 of 1962, S. 11 (w.e.f. 27-7-1964).
CHAPTER 3 - IMPORT OF DRUGS 1[AND COSMETICS]
15. Jurisdiction.-No court inferior to that 2[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under Section 13.
1 Added by Act 68 of 1982, S. 4 (w.e.f. 1-2-1983).
2 Subs. by Act 68 of 1982, S. 11 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
16. Standards of quality.- 2[(1) For the purposes of this Chapter, the expression "standard quality" means-
(a) in relation to a drug, that the drug complies with the standard set out in 3[the Second Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]
(2) The 4[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 5[the Second Schedule] for the purposes of this Chapter, and thereupon [the Second Schedule] shall be deemed to be amended accordingly.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by S. 12, ibid., for sub-section (1) (w.e.f. 27-7-1964).
3 Subs. by Act 13 of 1964, S. 11, for "the Schedule" (w.e.f. 15-9-1964).
4 Subs. by Act 11 of 1955, S. 8, for "State Government".
5 Subs. by Act 13 of 1964, S. 11, for "the Schedule" (w.e.f. 15-9-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[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 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.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ss. 17, 17-A, 17-B, 17-C and 17-D subs. for Ss. 17, 17-A and 17-B by Act 68 of 1982, S. 13 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
17-A. 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 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 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
17-B. 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.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
17-C. 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.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
17-D. 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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[17-E. 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 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Inserted by Act 26 of 2008, Section 2 (w.e.f. 10-8-2009).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
18. Prohibition of manufacture and sale of certain drugs and cosmetics.-From such date 2 as 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 this behalf-
(a) manufacture for sale 11[or for distribution], or sell, or stock or exhibit 3[or offer] for sale, or distribute-
4[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
5(ii) any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;]
6[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 7[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 claims 8[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;
9[(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) sell, or stock or exhibit 10[or offer] for sale, or distribute any drug 11[or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;
(c) manufacture for sale 17[or for distribution] or sell, or stock or exhibit 17[or offer] for sale, or distribute any drug 18[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:
Provided further that the 12[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale 13[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.
Explanation.- 14[***]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 18 read as:
____________________________________________________________
18. Prohibition of manufacture and sale of certain drugs and cosmetics.-From such date 15 as 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 this behalf-
(a) manufacture for sale 11[or for distribution], or sell, or stock or exhibit 16[or offer] for sale, or distribute-
17[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;]
18[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 19[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 claims 20[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;
21[(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) sell, or stock or exhibit 22[or offer] for sale, or distribute any drug 23[or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;
(c) manufacture for sale 17[or for distribution] or sell, or stock or exhibit 17[or offer] for sale, or distribute any drug 18[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:
Provided further that the 24[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale 25[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.
Explanation.- 26[***]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 1st April, 1947 for sub-clauses (i), (ii), (iv) and (v) of cl. (a) and cls. (b) and (c); 1st April, 1949 for sub-clause (iii) of cl. (a) insofar as it takes effect in Delhi, Ajmer and Coorg, see Noti. No. 18-12-46-D-II, dt. 11th Feb., 1947, Gaz. of India, 1947, Pt. I, p. 189, as amended by Noti. No. F. 1-2/48-D(II), dt. 29th Sept., 1948; 1st April, 1953, for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide Noti. No. S.R.O. 664, dt. 30th March, 1953, Gaz. of India, 1953, Pt. II, S. 3, p. 451.
3 Ins. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
4 Subs. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
5 Substituted by Act 26 of 2008, Section 3 (w.e.f. 10-8-2009).
6 Subs. by Act 11 of 1955, S. 9, for sub-clause (iii).
7 Subs. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
8 Subs. by ibid., S. 9, for "to cure or mitigate".
9 Subs. by Act 21 of 1962, S. 14, for sub-clause (v) (w.e.f. 27-7-1964).
10 Ins. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
11 Ins. by Act 21 of 1962, S. 14 (w.e.f. 27-7-1964).
12 Subs. by Act 11 of 1955, S. 9, for "State Government".
13 Ins. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
14 Omitted by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
15 1st April, 1947 for sub-clauses (i), (ii), (iv) and (v) of cl. (a) and cls. (b) and (c); 1st April, 1949 for sub-clause (iii) of cl. (a) insofar as it takes effect in Delhi, Ajmer and Coorg, see Noti. No. 18-12-46-D-II, dt. 11th Feb., 1947, Gaz. of India, 1947, Pt. I, p. 189, as amended by Noti. No. F. 1-2/48-D(II), dt. 29th Sept., 1948; 1st April, 1953, for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide Noti. No. S.R.O. 664, dt. 30th March, 1953, Gaz. of India, 1953, Pt. II, S. 3, p. 451.
16 Ins. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
17 Subs. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
18 Subs. by Act 11 of 1955, S. 9, for sub-clause (iii).
19 Subs. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
20 Subs. by ibid., S. 9, for "to cure or mitigate".
21 Subs. by Act 21 of 1962, S. 14, for sub-clause (v) (w.e.f. 27-7-1964).
22 Ins. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
23 Ins. by Act 21 of 1962, S. 14 (w.e.f. 27-7-1964).
24 Subs. by Act 11 of 1955, S. 9, for "State Government".
25 Ins. by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
26 Omitted by Act 68 of 1982, S. 14 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[18-A. 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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 13 of 1964, S. 14 (w.e.f. 15-9-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[18-B. 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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 68 of 1982, S. 15 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
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 2[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) 3[For the purposes of Section 18 a drug shall not be deemed to be misbranded or adulterated 4[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 for the manufacture or preparation of the drug 5[or cosmetic] as an article of commerce in a state fit for carriage or consumption, and not to increase the bulk, weight or measure of the drug 6[or cosmetic] or to conceal its inferior quality or other defects; or
7[***]
(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 drug 8[or cosmetic] occurring after the vendor or distributor became aware of such intermixture.
9[(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.]
STATE AMENDMENTS
SECTION 19-A
Uttar Pradesh
"19-A. Burden of proof.-When any drug or cosmetic is seized from any person under clause (c) of Section 22 by an Inspector in the reasonable belief that such drug or cosmetic is misbranded or adulterated, the burden of proving that such drug or cosmetic is not misbranded or adulterated shall be on the person from whose possession such drug or cosmetic was seized." [U.P. Act 47 of 1975, Section 5]
West Bengal
"19-A. Burden of proof.-When any drug or cosmetic in seized from any person in the reasonable belief that such drug or cosmetic is misbranded or adulterated, the burden of proving, that such drug or cosmetic is not misbranded or adulterated shall be on the person from whose possession such drug or cosmetic was seized." [W.B. Act 42 of 1973, Section 5]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
3 Subs. by Act 13 of 1964, S. 15, for certain words (w.e.f. 15-9-1964).
4 Ins. by Act 68 of 1982, S. 16 (w.e.f. 1-2-1983).
5 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
6 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
7 Cl. (aa) ins. by Act 11 of 1955, S. 10, omitted by Act 13 of 1964, S. 15 (w.e.f. 15-9-1964).
8 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
9 Subs. by Act 13 of 1964, S. 15, for sub-section (3) (w.e.f. 15-9-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[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 areas in the State and in respect of such drugs or 3[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 thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 4[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.
5[(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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by Act 35 of 1960, S. 4, for the original Ss. 20 and 21 (w.e.f. 16-3-1961).
3 Subs. by Act 21 of 1962, S. 16, for "class of drugs" (w.e.f. 27-7-1964).
4 Subs. by Act 21 of 1962, S. 16, for "class of drugs" (w.e.f. 27-7-1964).
5 Ins. by Act 68 of 1982, S. 17 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
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 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, the drugs or 2[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.
(3) No person who has any financial interest 3[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 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 4[having the prescribed qualifications,] as the Government appointing him may specify in this behalf.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by Act 21 of 1962, S. 17, for "class of drugs" (w.e.f. 27-7-1964).
3 Subs. by S. 17, ibid., for "in the manufacture, import or sale of drugs" (w.e.f. 27-7-1964).
4 Ins. by Act 68 of 1982, S. 18 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[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,-
3[(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;]
4[(cc) examine any record, register, document or any other material object found 5[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;]
6[(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 on any rules made thereunder.
(2) The provisions of the 7[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 authority of a warrant issued under 8[Section 94] of the said Code.
9[(2-A) 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 produced 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 under this Chapter, 10[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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by Act 11 of 1955, S. 11, for S. 22.
3 Subs. by Act 68 of 1982, S. 19 (w.e.f. 1-2-1983).
4 Ins. by Act 35 of 1960, S. 5 (w.e.f. 16-3-1961).
5 Subs. by Act 68 of 1982, S. 19 (w.e.f. 1-2-1983).
6 Ins. by ibid.
7 Subs. by Act 68 of 1982, S. 19 (w.e.f. 1-2-1983).
8 Subs. by Act 68 of 1982, S. 19 (w.e.f. 1-2-1983).
9 Ins. by ibid.
10 Ins. by Act 68 of 1982, S. 19 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
23. Procedure of Inspectors.-(1) Where an Inspector takes any sample of a drug 2[or cosmetic] under this Chapter, he shall tender the fair price thereof and may acquire a written acknowledgement therefor.
(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of any drug 3[or cosmetic] under clause (c) of Section 22, he shall tender a receipt therefor in the prescribed form.
(3) Where an Inspector takes a sample of a drug 4[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:
Provided that where the sample is taken from premises whereon the drug 5[or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only:
Provided further that where the drug 6[or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 7[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 drug 8[or cosmetic]; and
9[(iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under Section 18-A.]
(5) Where an Inspector takes any action under clause (c) of Section 22,-
(a) he shall use all despatch in ascertaining whether or not the drug 10[or cosmetic] contravenes any of the provisions of Section 18 and, if it is ascertained that the drug 11[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;
(b) if he seizes the stock of the drug 12[or cosmetic], he shall as soon as may be, inform a 13[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 the defect may be remedied by the possessor of the drug 14[or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.
15[(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, inform a [Judicial]16 Magistrate and take his orders as to the custody thereof.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
3 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
4 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
5 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
6 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
7 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
8 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
9 Subs. by Act 13 of 1964, S. 16, for cl. (iii) (w.e.f. 15-9-1964).
10 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
11 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
12 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
13 Ins. by Act 68 of 1982, S. 20 (w.e.f. 1-2-1983).
14 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
15 Ins. by Act 35 of 1960, S. 6 (w.e.f. 16-3-1961).
16 Ins. by Act 68 of 1982, S. 20 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
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 drug 2[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 drug 3[or cosmetic] is being manufactured or is kept, as the case may be.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
3 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
25. Reports of Government Analysts.-(1) The Government Analyst to whom a sample of any drug 2[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 taken 3[and another copy to the person, if any, whose name, address and other particulars have been disclosed under Section 18-A], 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 of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken 4[or the person whose name, address and other particulars have been disclosed under Section 18-A] 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 or the accused, cause the sample of the drug 5[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.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
3 Subs. by Act 13 of 1964, S. 17 for certain words (w.e.f. 15-9-1964).
4 Subs. by S. 17, ibid., for "or the said warrantor" (w.e.f. 15-9-1964).
5 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
26. Purchaser of drugs or cosmetics enabled to obtain test or analysis.-Any person 2[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 analysis to a Government Analyst any drug 3[or cosmetic] purchased by him 4[or it] and to receive a report of such test or analysis signed by the Government Analyst.
5[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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 71 of 1986, S. 2 (w.e.f. 15-9-1987).
3 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
4 Ins. by Act 71 of 1986, S. 2 (w.e.f. 15-9-1987).
5 Ins. by Act 71 of 1986, S. 2 (w.e.f. 15-9-1987).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[26-A. Power of Central Government to 3[regulate, restrict or 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, 4[regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 26-A read as:
____________________________________________________________
5[26-A. 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, prohibit the manufacture, sale or distribution of such drug or cosmetic.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 68 of 1982, S. 21 (w.e.f. 1-2-1983).
3 Substituted for "prohibit" by Act 26 of 2008, Section 4 (w.e.f. 10-8-2009).
4 Substituted for "prohibit" by Act 26 of 2008, Section 4 (w.e.f. 10-8-2009).
5 Ins. by Act 68 of 1982, S. 21 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[26-B. Power 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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Inserted by Act 26 of 2008, Section 5 (w.e.f. 10-8-2009).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[27. Penalty for manufacturer, 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,-
(a) any drug deemed to be adulterated under Section 17-A or spurious under Section 3[17-B 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 be 4[punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more];
5[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 his 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 17-A, 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 shall 6[not be less than three years 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 of 7[less than three years and of fine of less than one lakh rupees];
(c) any drug deemed to be spurious under Section 17-B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall 8[not less than seven years but which may extend to imprisonment for life and with fine which shall not be (sic 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 of 9[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 years 10[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.]
STATE AMENDMENTS
Uttar Pradesh [Amendment to old Section 27 prior to amendment by Act 68 of 1982]
"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, sells, stocks or exhibits for sale or distributes-
(a) any drug-
(i) deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) or clause (2) of Section 17 or adulterated under Section 17-B, or
(ii) without a valid licence as required under clause (c) of Section 18; or
(b) any drug other than a drug referred to in clause (a) in contravention of any of the provisions of this Chapter or any rule made thereunder-
shall be punished with imprisonment for life:
Provided that the Court may, for any special reasons to be recorded in writing impose a sentence of imprisonment which is less than imprisonment for life." [U.P. Act 47 of 1975, Section 5]
West Bengal [Amendment to old Section 27 prior to amendment by Act 68 of 1982]
In Section 27,-
(a) In clause (a),-
(i) for the words "for a term which shall not be less than one year but which may extend to ten years", the words "for life" shall be substituted;
(ii) in the proviso, for the words "imprisonment of less than one year", the words "less than imprisonment for life" shall be substituted;
(b) in clause (b), for the words "for a term which may extend to three years", the words "for life" shall be substituted. [W.B. Act 42 of 1973, Section 5]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 27 read as:
____________________________________________________________
11[27. Penalty for manufacturer, 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,-
(a) any drug deemed to be adulterated under Section 17-A or spurious under Section 17-B or 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 be 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;
(b) any drug-
(i) deemed to be adulterated under Section 17-A, 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 shall 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:
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 and of fine of less than five thousand rupees;
(c) any drug deemed to be spurious under Section 17-B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than five 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 three years but not less than one year;
(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 years and with fine:
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 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ss. 27 and 27-A subs. by Act 68 of 1982, S. 22 (w.e.f. 1-2-1983).
3 Substituted for "17-B or which" by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
4 Substituted by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
5 Inserted by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
6 Substituted by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
7 Substituted by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
8 Substituted by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
9 Substituted by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
10 Substituted for "and with fine" by Act 26 of 2008, Section 6 (w.e.f. 10-8-2009).
11 Ss. 27 and 27-A subs. by Act 68 of 1982, S. 22 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[27-A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.-Whoever himself or by any other person on his behalf manufacturers for sale or for distribution, or sells, or stocks or exhibits or offers for sale-
3[(i) any cosmetic deemed to be spurious under Section 17-D or adulterated under Section 17-E 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 the 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.]
STATE AMENDMENTS
Uttar Pradesh (Amendment to old Section 27-A prior to amendment by Act 68 of 1982)
"27-A. 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, sells, stocks or exhibits for sale, or distributes any cosmetic in contravention of any provisions of this Chapter or any rule made thereunder, shall be punishable with imprisonment for life and shall also be liable to fine:
Provided that the Court may, for adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment which is less than imprisonment for life." [U.P. Act 47 of 1975, Section 5]
West Bengal (Amendment to old Section 27-A prior to amendment by Act 68 of 1982)
In Section 27-A, for the words "a term which may extend to one year, or with fine which may extend to five hundred rupees", the words "life or with fine" shall be substituted. [W.B. Act 42 of 1973, Section 5]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 27-A read as:
____________________________________________________________
2[27-A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.-Whoever himself or by any other person on his behalf manufacturers for sale or for distribution, or sells, or stocks or exhibits or offers for sale-
(i) any cosmetic deemed to be spurious under Section 17-C shall be punishable with imprisonment for a term which may extend to three years and with fine;
(ii) any cosmetic other than a cosmetic referred to in clause (i) above 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 one thousand rupees or with both.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ss. 27 and 27-A subs. by Act 68 of 1982, S. 22 (w.e.f. 1-2-1983).
3 Substituted by Act 26 of 2008, Section 7 (w.e.f. 10-8-2009).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[28. Penalty for non-disclosure of the name of the manufacturer, etc.-Whoever contravenes the provisions of Section 18-A 3[or Section 24] shall be punishable with imprisonment for a term which may extend to one year, or 4[with fine which shall not be less than twenty thousand rupees or with both].]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 28 read as:
____________________________________________________________
5[28. Penalty for non-disclosure of the name of the manufacturer, etc.-Whoever contravenes the provisions of Section 18-A 6[or Section 24] shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to 7[one thousand rupees], or with both.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by Act 13 of 1964, S. 19, for S. 28 (w.e.f. 15-9-1964).
3 Ins. by Act 68 of 1982, S. 23 (w.e.f. 1-2-1983).
4 Substituted by Act 26 of 2008, Secion 8 (w.e.f. 10-8-2009).
5 Subs. by Act 13 of 1964, S. 19, for S. 28 (w.e.f. 15-9-1964).
6 Ins. by Act 68 of 1982, S. 23 (w.e.f. 1-2-1983).
7 Subs. for "five hundred rupees" by Act 68 of 1982, S. 23 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[28-A. Penalty for not keeping documents, etc., and for non-disclosure of information.-Whoever without reasonable cause or excuse, contravenes the provisions of Section 18-B shall be punishable with imprisonment for a term which may extend to one year or 3[with fine which shall not be less than twenty thousand rupees or with both].
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 28-A read as:
____________________________________________________________
4[28-A. Penalty for not keeping documents, etc., and for non-disclosure of information.-Whoever without reasonable cause or excuse, contravenes the provisions of Section 18-B 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.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ss. 28-A and 28-B ins. by Act 68 of 1982, S. 24 (w.e.f. 1-2-1983).
3 Substituted by Act 26 of 2008, Section 9 (w.e.f. 10-8-2009).
4 Ss. 28-A and 28-B ins. by Act 68 of 1982, S. 24 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
28-B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of Section 26-A.-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 26-A, 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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
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 drug 2[or cosmetic], shall be punishable with fine which may extend to 3[five thousand rupees].
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 29 read as:
____________________________________________________________
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 drug 4[or cosmetic], shall be punishable with fine which may extend to five hundred rupees.
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
3 Substituted for "five hundred rupees" by Act 26 of 2008, Section 10 (w.e.f. 10-8-2009).
4 Ins. by Act 21 of 1962, S. 15 (w.e.f. 27-7-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[30. Penalty for subsequent offences.-3[(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 4[not be 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 of 5[less than seven years and of fine of less than one lakh rupees];
(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 6[shall not be 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 than 7[fifty thousand rupees], or with both.]
8[(1-A) Whoever, having been convicted of an offence under Section 27-A 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 to 9[two thousand rupees], or with both.]
(2) Whoever, having been convicted of an offence under 10[***] Section 29 is again convicted of an offence under the same section shall be punishable with imprisonment which may extend to 11[two years, or with fine which shall not be less than ten thousand rupees or with both].]
STATE AMENDMENTS
Uttar Pradesh (Prior to amendment of principal section by Act 68 of 1982)
"30. All offences punishable under this Chapter shall be cognizable and non-bailable." [U.P. Act 47 of 1975, Section 5]
West Bengal (Prior to amendment of principal section by Act 68 of 1982)
In Section 30,-
(a) in sub-section (1),-
(i) in clause (a), for the words "ten years", the words "imprisonment for life" shall be substituted;
(ii) in clause (b), for the words "may extend to ten years or with fine, or with both", the words "shall not be less than two years but which may extend to imprisonment for life and shall also be liable to fine", shall be substituted;
(b) in sub-section (1-A), for the words "may extend to two years, or with fine which may extend to one thousand rupees, or with both", the words "shall not be less than two years but which may extend to imprisonment for life and shall also be liable to fine" shall be substituted. [W.B. Act 42 of 1973, Section 5]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 30 read as:
____________________________________________________________
12[30. Penalty for subsequent offences.- 13[(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 be less than two years but which may extend to six years and with fine which shall not be less than ten thousand 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 of less than two years and of fine of less than ten thousand rupees;
(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 shall not be less than six years but which may extend to ten years and with fine which shall not be less than ten thousand 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 than five thousand rupees, or with both.]
14[(1-A) Whoever, having been convicted of an offence under Section 27-A 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 to 180 17[two thousand rupees], or with both.]
(2) Whoever, having been convicted of an offence under 15[***] Section 29 is again convicted of an offence under the same section shall be punishable with imprisonment which may extend to 16[ten years] or with fine, or with both.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by Act 11 of 1955, S. 14, for S. 30.
3 Subs. by Act 68 of 1982, S. 25 (w.e.f. 1-2-1983).
4 Substituted by Act 26 of 2008, Section 11 (w.e.f. 10-8-2009).
5 Substituted by Act 26 of 2008, Section 11 (w.e.f. 10-8-2009).
6 Substituted by Act 26 of 2008, Section 11 (w.e.f. 10-8-2009).
7 Substituted by Act 26 of 2008, Section 11 (w.e.f. 10-8-2009).
8 Ins. by Act 21 of 1962, S. 20 (w.e.f. 27-7-1964).
9 Subs. for "one thousand rupees" by Act 68 of 1982, S. 25 (w.e.f. 1-2-1983).
10 The words and figures "Section 28 or" omitted by Act 13 of 1964, S. 20 (w.e.f. 15-9-1964).
11 Substituted by Act 26 of 2008, Section 11 (w.e.f. 10-8-2009).
12 Subs. by Act 11 of 1955, S. 14, for S. 30.
13 Subs. by Act 68 of 1982, S. 25 (w.e.f. 1-2-1983).
14 Ins. by Act 21 of 1962, S. 20 (w.e.f. 27-7-1964).
15 The words and figures "Section 28 or" omitted by Act 13 of 1964, S. 20 (w.e.f. 15-9-1964).
16 Subs. by S. 20, ibid., for "two years".
17 Subs. for "one thousand rupees" by Act 68 of 1982, S. 25 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
31. Confiscation.- 2[(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 stock of the drug [or cosmetic] in respect of which the contravention has been made shall be liable to confiscation [and if such contravention is in respect of -
3[(i) manufacture of any drug deemed to be misbranded under Section 17, adulterated under Section 17-A or spurious under Section 17-B; or]
(ii) 4[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.]
5[(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 cosmetic is not of standard quality 6[or is a 7[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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Renumbered as sub-section (1) by Act 35 of 1960, S. 9 (w.e.f. 16-3-1961).
3 Subs. by Act 68 of 1982, S. 26 (w.e.f. 1-2-1983).
4 Subs. by Act 68 of 1982, S. 26 (w.e.f. 1-2-1983).
5 Sub-section (2), ins. by Act 35 of 1960, S. 9, subs. by Act 21 of 1962, S. 21 (w.e.f. 27-7-1964).
6 Subs. by Act 13 of 1964, S. 21, for "or is a misbranded drug"(w.e.f. 15-9-1964).
7 Subs. by Act 68 of 1982, S. 26 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[31-A. 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 by any department of Government as they apply in relation to the manufacture, sale or distribution of drugs by any other person.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 13 of 1964, S. 22 (w.e.f. 15-9-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
32. Cognizance of offences.-2[(1) No prosecution under this Chapter shall be instituted except by-
(a) an Inspector; or
(b) any gazetted officer of the Central Government or a State Government authorised 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 Session 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.
STATE AMENDMENTS
Punjab, Haryana and Chandigarh
In sub-section (2) of Section 32, for the words "a Magistrate", the words "a Judicial Magistrate" shall be substituted.-Punjab Act 25 of 1964.
West Bengal
For Section 32, the following section shall be substituted, namely:-
"32.Cognizance of offences and arrest without warrant.-(1) All offences punishable under this Act shall be cognizable and non-bailable.
(2) Any police officer not below the rank of a Sub-Inspector of Police may arrest without warrant any person against whom a reasonable complaint has been made or credible information has been received of his having been concerned in any of the offences punishable under this Act." [W.B. Act 42 of 1973, Section 5]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 32 read as:
____________________________________________________________
32. Cognizance of offences.-(1) No prosecution under this Chapter shall be instituted except by an Inspector 3[or by the person aggrieved or by a recognised consumer association whether such person is a member of that association or not].
(2) No Court inferior to that of 4[a Metropolitan Magistrate or of a Judicial Magistrate of the first class] 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 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Substituted by Act 26 of 2008, Section 12 (w.e.f. 10-8-2009).
3 Ins. by Act 71 of 1986, S. 3 (w.e.f. 15-9-1987).
4 Subs. by Act 68 of 1982, S. 27 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[32-A. 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, notwithstanding anything contained 3[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.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 13 of 1964, S. 23 (w.e.f. 15-9-1964).
3 Subs. by Act 68 of 1982, S. 28 (w.e.f. 1-2-1983).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[32-B. 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 28-A 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 institution of any prosecution, be compounded by the Central Government or by any State Government or any officer authorised in this behalf by the 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 offence 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 offence 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 proceeding or further proceeding, as the case may be, shall be taken against the offender in respect of the offence so compounded and the offender, if in custody, shall be released forthwith.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Inserted by Act 26 of 2008, Section 13 (w.e.f. 10-8-2009).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
33. Powers of Central Government to make rules.- 2[(1) The Central Government may after consultation with 3[, 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 rule may-
(a) provide for the establishment of laboratories for testing and analysing drugs 4[or cosmetics];
(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining whether a drug 5[or cosmetic] is of standard quality;
(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;
6[(dd) prescribe under clause (d) of Section 7[17-A] the colour or colours which a drug may bear or contain for purposes of colouring;]
8[(dda) prescribe under clause (d) of Section 17-E the colour or colours which a cosmetic may bear or contain the puposes of colouring;]
(e) prescribe the forms of licences for the manufacture for sale 9[or for distribution], for the sale and for the distribution of drugs or any specified drug or class of drugs 10[or of cosmetics or any specified cosmetic or class of cosmetics], the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same 11[the qualifications of such authority] and the fees payable therefor 12[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;]
13[(ee) prescribe the records, registers or other documents to be kept and maintained under Section 18-B;
(eea) prescribe the fees for the inspection (for the purposes of grant or renewal of licences) 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 (2-A) of Section 22;]
(f) specify the diseases or ailments which a drug may not purport or claim 14[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;
(h) 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 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 containers of drugs 15[or cosmetics] 16[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 17[or cosmetics] packed in contravention of such conditions;
(j) regulate the mode of labelling packed drugs 18[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 to 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;
(m) 19[***]
20[(n) prescribe the powers and duties of Inspectors 21[and the qualifications of the authority to which such Inspectors shall be subordinate] and 22[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 56 and the fees payable therefor;
23[(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; 24[* * *]]
(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 25[or cosmetic or class of cosmetics; 26[and]]
27(r) sum which may be specified by the Central Government under Section 32-B.]
28[***]
STATE AMENDMENTS
Maharashtra.-In Section 33 in sub-section (2),-
(a) in clause (e), the words "and the fees payable therefor" shall be deleted;
(b) clause (eea) shall be deleted; and
(c) in clause (o), the words "and the fees payable therefor" shall be deleted. (Vide Mah. Act. 31 of 1989, S. 2.)
Section 33-1A
Maharashtra.-After Section 33 of the principal Act, the following section shall be inserted, namely:-
"33-1A. Power of State Government to make rules.-The State Government may, by notification in the Official Gazette and subject to the condition of previous publication, make rules, to prescribe the fees payable for the following purposes of this Chapter, namely:-
(a) grant or renewal, of a licence for the manufacture for sale or distribution for the sale and for the distribution of drugs or any specified drugs or class of drugs or of cosmetics or any specified cosmetics or class of cosmetics;
(b) inspection (for the purposes of grant or renewal of licences) of premises, wherein any drug or cosmetic is being or is proposed to be manufactured;
(c) test or analysis of any drug or cosmetic by Government Analyst; and
(d) any other matter for which fees may be prescribed under this Chapter." (Vide Mah. Act 31 of 1989, S. 3.)
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 33 read as:
____________________________________________________________
33. Powers of Central Government to make rules.- 29[(1) The Central Government may after consultation with 30[, 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 rule may-
(a) provide for the establishment of laboratories for testing and analysing drugs 31[or cosmetics];
(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining whether a drug 32[or cosmetic] is of standard quality;
(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;
33[(dd) prescribe under clause (d) of Section 34[17-A] the colour or colours which a drug may bear or contain for purposes of colouring;]
(e) prescribe the forms of licences for the manufacture for sale 35[or for distribution], for the sale and for the distribution of drugs or any specified drug or class of drugs 36[or of cosmetics or any specified cosmetic or class of cosmetics], the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same 37[the qualifications of such authority] and the fees payable therefor 38[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;]
39[(ee) prescribe the records, registers or other documents to be kept and maintained under Section 18-B;
(eea) prescribe the fees for the inspection (for the purposes of grant or renewal of licences) 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 (2-A) of Section 22;]
(f) specify the diseases or ailments which a drug may not purport or claim 40[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;
(h) 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 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 containers of drugs 41[or cosmetics] 42[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 43[or cosmetics] packed in contravention of such conditions;
(j) regulate the mode of labelling packed drugs 44[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 to 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;
(m) 45[***]
46[(n) prescribe the powers and duties of Inspectors 47[and the qualifications of the authority to which such Inspectors shall be subordinate] and 48[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 56 and the fees payable therefor;
49[(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; and]
(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 50[or cosmetic or class of cosmetics;]
51[***]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Subs. by Act 11 of 1955, S. 15, for sub-section (1).
3 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
4 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
5 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
6 Ins. by Act 13 of 1964, S. 24 (w.e.f. 15-9-1964).
7 Subs. for "17-B" by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
8 Substituted by Act 26 of 2008, Section 14 (w.e.f. 10-8-2009).
9 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
10 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
11 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
12 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
13 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
14 Subs. by Act 11 of 1955, S. 15 for "to cure or mitigate".
15 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
16 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
17 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
18 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
19 Cl. (m) omitted by Act 13 of 1964, S. 24 (w.e.f. 15-9-1964).
20 Subs. by Act 35 of 1960, S. 10, for cl. (n) (w.e.f. 16-3-1961).
21 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
22 Subs. by Act 21 of 1962, S. 22, for "the drugs or class of drugs" (w.e.f. 27-7-1964).
23 Subs. by Act 13 of 1964, S. 24, for cl. (p) (w.e.f. 15-9-1964).
24 The word "and" omitted by Act 26 of 2008, Section 14 (w.e.f. 10-8-2009).
25 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
26 Inserted by Act 26 of 2008, Section 14 (w.e.f. 10-8-2009).
27 Inserted by Act 26 of 2008, Section 14 (w.e.f. 10-8-2009).
28 Sub-section (3) ins. by Act 35 of 1960, omitted by Act 13 of 1964, S. 24 (w.e.f. 15-9-1964).
29 Subs. by Act 11 of 1955, S. 15, for sub-section (1).
30 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
31 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
32 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
33 Ins. by Act 13 of 1964, S. 24 (w.e.f. 15-9-1964).
34 Subs. for "17-B" by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
35 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
36 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
37 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
38 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
39 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
40 Subs. by Act 11 of 1955, S. 15 for "to cure or mitigate".
41 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
42 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
43 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
44 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
45 Cl. (m) omitted by Act 13 of 1964, S. 24 (w.e.f. 15-9-1964).
46 Subs. by Act 35 of 1960, S. 10, for cl. (n) (w.e.f. 16-3-1961).
47 Ins. by Act 68 of 1982, S. 29 (w.e.f. 1-2-1983).
48 Subs. by Act 21 of 1962, S. 22, for "the drugs or class of drugs" (w.e.f. 27-7-1964).
49 Subs. by Act 13 of 1964, S. 24, for cl. (p) (w.e.f. 15-9-1964).
50 Ins. by Act 21 of 1962, S. 22 (w.e.f. 27-7-1964).
51 Sub-section (3) ins. by Act 35 of 1960, omitted by Act 13 of 1964, S. 24 (w.e.f. 15-9-1964).
CHAPTER 4 - MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
2[33-A. Chapter not to apply to Ayurvedic (including Siddha) or Unani drugs.-Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to Ayurvedic (including Siddha) or Unani drugs.]
1 Ins. by Act 68 of 1982, S. 12 (w.e.f. 1-2-1983).
2 Ins. by Act 13 of 1964, S. 35 (w.e.f. 1-2-1969).
1[CHAPTER IV-A. PROVISIONS RELATING TO 2[AYURVEDIC, SIDDHA AND UNANI DRUGS]
33-B. Application of Chapter IV-A.-This Chapter shall apply only to 3[Ayurvedic, Siddha and Unani drugs].
1 Ins. by Act 13 of 1964 (w.e.f. 1-2-1969).
2 Subs. by Act 68 of 1982, S. 2 (w.e.f. 1-2-1983).
3 Subs. by Act 68 of 1982, S. 2 (w.e.f. 1-2-1983).
1[CHAPTER IV-A. PROVISIONS RELATING TO 2[AYURVEDIC, SIDDHA AND UNANI DRUGS]
33-C. 3[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 therein, constitute a Board (to be called the 4[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:-
(i) The Director-General of Health Services, ex officio;
(ii) the Drugs Controller, India, ex officio;
5[(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 34-F, 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;
6[(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 Darvyaguna, and Bhaishajya Kalpana, to be nominated by the Central Government;
(x) one teacher in ILM-UL-ADVIA and TAKLIS-WADAWASAZI, to be nominated by the Central Government;
7[(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 systems 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.
1 Ins. by Act 13 of 1964 (w.e.f. 1-2-1969).
2 Subs. by Act 68 of 1982, S. 2 (w.e.f. 1-2-1983).
3 Subs. by Act 68 of 1982, S. 30 (w.e.f. 1-2-1983). See also S. 42 of Act 68 of 1982 given in the Appendix.
4 Subs. by Act 68 of 1982, S. 30 (w.e.f. 1-2-1983). See also S. 42 of Act 68 of 1982 given in the Appendix.
5 Subs. by Act 68 of 1982, S. 30 (w.e.f. 1-2-1983). See also S. 42 of Act 68 of 1982 given in the Appendix.
6 Subs. by Act 68 of 1982, S. 30 (w.e.f. 1-2-1983). See also S. 42 of Act 68 of 1982 given in the Appendix.
7 Subs. by Act 68 of 1982, S. 30 (w.e.f. 1-2-1983). See also S. 42 of Act 68 of 1982 given in the Appendix.
1[CHAPTER IV-A. PROVISIONS RELATING TO 2[AYURVEDIC, SIDDHA AND UNANI DRUGS]
3[33-D. 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.
1 Ins. by Act 13 of 1964 (w.e.f. 1-2-1969).
2 Subs. by Act 68 of 1982, S. 2 (w.e.f. 1-2-1983).
3 Ss. 33-D to 33-EED subs. for Ss. 33-D and 33-E by Act 68 of 1982, S. 31 (w.e.f. 1-2-1983).
CHAPTER 4-A. PROVISIONS RELATING TO [AYURVEDIC, SIDDHA AND UNANI DRUGS
33-E. Misbranded drugs.-For the purposes of this Chapter, an Ayurvedic, Siddha or Unani 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.
33-EE. 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 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.
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.
33-EEA. 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.
33-EEB. 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.
33-EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs.-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 this behalf, shall-
(a) manufacture for sale or for distribution-
(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug;
(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
(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 shall 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.
33-EED. 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 Ayurvedic, 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.]
33-F. 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.]
1 Ins. by Act 68 of 1982, S. 32 (w.e.f. 1-2-1983).
33-G. 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 qualification, 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.
33-H. 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 sections, shall be constructed as references to "Ayurvedic, Siddha or Unani drug".
1[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,-
2[(a) any Ayurvedic, Siddha or Unani drug-
(i) deemed to be misbranded under Section 33-E,
(ii) deemed to be adulterated under Section 33-EE, or
(iii) without a valid licence or in violation of any of the conditions thereof, as required under Section 33-EEC,
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 33-EEA, 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 than 3[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 than 4[fifty thousand rupees or three times the value of the drugs confiscated, whichever is more]; or
5[(c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of any notification issued under 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 33-H or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to 6[six months and with fine which shall not be less than ten thousand rupees].
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 33-I read as:
____________________________________________________________
7[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,-
(a) any Ayurvedic, Siddha or Unani drug-
(i) deemed to be adulterated under Section 33-EE, or
(ii) without a valid licence as required under clause (c) of Section 33-EEC,
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;
(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under Section 33-EEA, 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 than five thousand 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 of less than one year and of fine of less than five thousand rupees; or
(2) contravenes any other provisions of this Chapter or of Section 24 as applied by Section 33-H or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to three months and with fine which shall not be less than five hundred rupees.
1 Subs. by Act 68 of 1982, S. 33 (w.e.f. 1-2-1983).
2 Substituted by Act 26 of 2008, Section 15 (w.e.f. 10-8-2009).
3 Substituted for "five thousand rupees" by Act 26 of 2008, Section 15 (w.e.f. 10-8-2009).
4 Substituted for "five thousand rupees" by Act 26 of 2008, Section 15 (w.e.f. 10-8-2009).
5 Inserted by Act 26 of 2008, Section 15 (w.e.f. 10-8-2009).
6 Substituted by Act 26 of 2008, Section 15 (w.e.f. 10-8-2009).
7 Subs. by Act 68 of 1982, S. 33 (w.e.f. 1-2-1983).
33-J. Penalty for subsequent offences.-Whoever having been 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 than 1[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 than 2[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 than 3[one lakh rupees or three times the value of the drugs confiscated, whichever is more];
(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 to 4[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].]
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 33-J read as:
____________________________________________________________
33-J. Penalty for subsequent offences.-Whoever having been 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 than two thousand rupees;
(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 than five thousand 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 of less than two years and of fine of less than five thousand rupees;
(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 to six months and with fine which shall not be less than one thousand rupees.]
1 Substituted for "two thousand rupees" by Act 26 of 2008, Section 16 (w.e.f 10-8-2009).
2 Substituted for "five thousand rupees" by Act 26 of 2008, Section 16 (w.e.f 10-8-2009).
3 Substituted for "five thousand rupees" by Act 26 of 2008, Section 16 (w.e.f 10-8-2009).
4 Substituted by Act 26 of 2008, Section 16 (w.e.f. 10-8-2009).
33-K. Confiscation.-Where any person has been convicted under this Chapter, the stock of the Ayurvedic, Siddha or Unani drug, in respect of which the contravention has been made, shall be liable to confiscation.
1[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.]
1 Inserted by Act 26 of 2008, Section 17 (w.e.f. 10-8-2009).
1[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.]
1 Inserted by Act 26 of 2008, Section 17 (w.e.f. 10-8-2009).
33-L. Application of provisions to Government departments.-The provisions of this Chapter except those contained in Section 33-K shall apply in relation to the manufacture for sale, sale or distribution of 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.
33-M. Cognizance of offences.-(1) No prosecution under this Chapter shall be instituted except by an Inspector 1[with the previous sanction of the authority specified under sub-section (4) of Section 33-G.]
(2) No Court inferior to that 2[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.
1 Ins. by Act 68 of 1982, S. 34 (w.e.f. 1-2-1983).
2 Subs. by Act 68 of 1982, S. 34 (w.e.f. 1-2-1983).
33-N. Power of Central Government to make rules.-(1) The Central Government may, 1[after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the first 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 analysing Ayurvedic, Siddha or Unani drugs;
(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining whether any 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 of Ayurvedic, Siddha or Unani drug 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 3[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];
4[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha or 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 not be included in such labels;]
(g) prescribe the conditions subject to which small quantities of Ayurvedic, Siddha or Unani drugs may be manufactured for the purpose of examination, test or analysis;
5[(gg) prescribe under clause (d) of Section 33-EE 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 33-EEB;] 6[* * *]
7[(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.
STATE AMENDMENTS
Maharashtra
In Section 33-N of the principal Act in sub-section (2), in clause (e), the words "and the fees payable therefor" shall be deleted. (Vide Mah. Act 31 of 1989, S. 4.)
SECTION 33-N-1
Maharashtra
After Section 33-N of the principal Act, the following section shall be inserted, namely:-
"33-N-1.Power of State Government to make rules.-The State Government may, by notification in the Official Gazette and subject to the condition of previous publication, make rules to prescribe the fees payable for the following purposes of this Chapter, namely:-
(a) grant or renewal of a licence for the manufacture for sale of Ayurvedic, Siddha or Unani drugs, and for sale of processed Ayurvedic, Siddha or Unani drugs;
(b) inspection (for the purpose of grant or renewal of licences) of premises, wherein any Ayurvedic, Siddha or Unani drugs is being or is proposed to be manufactured;
(c) test or analysis of any Ayurvedic, Siddha or Unani drug by Government Analyst; and
(d) any other matter for which fees may be prescribed under this Chapter." (Vide Mah. Act 31 of 1989, S. 4.)
____________________________________________________________
Prior to amendment by Act 26 of 2008, Section 33-N read as:
____________________________________________________________
33-N. Power of Central Government to make rules.-(1) The Central Government may, 1[after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the first 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 analysing Ayurvedic, Siddha or Unani drugs;
(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining whether any 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 of Ayurvedic, Siddha or Unani drug 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 3[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];
4[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha or 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 not be included in such labels;]
(g) prescribe the conditions subject to which small quantities of Ayurvedic, Siddha or Unani drugs may be manufactured for the purpose of examination, test or analysis;
5[(gg) prescribe under clause (d) of Section 33-EE 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 33-EEB;] and
(h) any other matter which is to be or may be prescribed under this Chapter.
1 Ins. by Act 68 of 1982, S. 35 (w.e.f. 1-2-1983).
2 Ins. by Act 68 of 1982, S. 35 (w.e.f. 1-2-1983).
3 Ins. by Act 68 of 1982, S. 35 (w.e.f. 1-2-1983).
4 Subs. by ibid.
5 Ins. by Act 68 of 1982, S. 35 (w.e.f. 1-2-1983).
6 The word "and" omitted by Act 26 of 2008, Section 18 (w.e.f. 10-8-2009).
7 Inserted by Act 26 of 2008, Section 18 (w.e.f. 10-8-2009).
CHAPTER 4-A. - PROVISIONS RELATING TO [AYURVEDIC, SIDDHA AND UNANI DRUGS
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 purpose of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly.]
1CHAPTER V - MISCELLANEOUS
2[3[33-P.] 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.]
1 Subs. by Act 11 of 1955, S. 16, S. 34.
2 Ins. by Act 35 of 1960, S. 11 (w.e.f. 16-3-1961).
3 S. 33-A renumbered as S. 33-P by Act 13 of 1964, S. 27 (w.e.f. 15-9-1964).
CHAPTER 5 - MISCELLANEOUS
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.
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[34-A. Offences by Government departments.-Where an offence under Chapter IV or Chapter IV-A 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 IV or Chapter IV-A, 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.]
1 Ins. by Act 13 of 1964, S. 28 (w.e.f. 15-9-1964).
1[34-AA. 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.]
1 Ins. by Act 68 of 1982, S. 36 (w.e.f. 1-2-1983).
35. Publication of sentences passed under this Act.-(1) If any person is convicted of an offence under this Act, 1[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 costs relating to the conviction and shall be recoverable in the same manner as those costs are recoverable.
1 Subs. by Act 68 of 1982, S. 37 (w.e.f. 1-2-1983).
36. Magistrate's power to impose enhanced penalties.-Notwithstanding anything contained in 1[***]2[the Code of Criminal Procedure, 1973 (2 of 1974)], it shall be lawful for 3[any Metropolitan Magistrate or any Judicial Magistrate of the first class] to pass any sentence authorised by this Act in excess of his powers under 4[***] the said Code.
1 The words and figures "S. 32 of" omitted by S. 29, ibid. (w.e.f. 15-9-1964).
2 Subs. by Act 68 of 1982, S. 38 (w.e.f. 1-2-1983).
3 Subs. by Act 68 of 1982, S. 38 (w.e.f. 1-2-1983).
4 The words and figures "S. 32 of" omitted by Act 68 of 1982, S. 29 (w.e.f. 15-9-1964).
1[36-A. Certain offences to be tried summarily.-Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), 2[all offences (except the offences triable by the Special Court under Section 36-AB of Court of Session) 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.]
________________________________________________________
Prior to amendment by Act 26 of 2008, Section 4 read as:
________________________________________________________
1[36-A. Certain offences to be tried summarily.-Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), all offences 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 68 of 1982, S. 39 (w.e.f. 1-2-1983).
2 Substituted for "all offences under this Act" by Act 26 of 2008, Section 19 (w.e.f. 10-8-2009).
1[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 and punishable under clauses (a) and (b) of Section 13, sub-section (3) of Section 22, clauses (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 Session as a Special Court or Special Courts for such area or areas 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 Session 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.]
1 Inserted by Act 26 of 2008, Section 20 (w.e.f. 10-8-2009).
1[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 clauses (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, clauses (a) and (c) of Section 27, Section 28, Section 28-A, Section 28-B and sub-sections (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 clauses (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, clauses (a) and (c) of Section 27, Section 28, Section 28-A, Section 28-B and sub-sections (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 of 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 a "Special Court" designated under Section 36-AB.]
1 Inserted by Act 26 of 2008, Section 20 (w.e.f. 10-8-2009).
1[36-AD. Application of Code of Criminal Procedure, 1973 to proceedings before Special Court.-(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 or bonds), shall apply to the proceedings before a Special Court and for the purposes of the said provisions, the Special Court shall be deemed to be a Court of Session 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 class or group of cases, a Special Public Prosecutor.
(2) A person shall not be qualified to be appointed as a 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 Section 2 of the Code of Criminal Procedure, 1973 (2 of 1974) and the provisions of that Code shall have effect accordingly.]
1 Inserted by Act 26 of 2008, Section 20 (w.e.f. 10-8-2009).
1[36-AE. 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.]
1 Inserted by Act 26 of 2008, Section 20 (w.e.f. 10-8-2009).
37. Protection of action taken in good faith.-No suit, prosecution or other legal proceedings 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 form 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.]
STATE AMENDMENTS
Maharashtra
In Section 38 of the principal Act, for the words "Every rule made" the words "Every rule made by the Central Government" shall be substituted. (Vide Mah. Act 31 of 1989, S. 6.)
SECTION 39
Maharashtra
After Section 38 the following section shall be inserted, namely:-
"39.Rules to be laid before State Legislature.-Every rule made by the State Government under this Act shall be laid, as soon as may be after it is made, before, each House of the State Legislature, 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 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, and notify such decision in the Official Gazette, the rule shall from the date of publication of such notification have effect only in such modified form 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 or omitted to be done under that rule." (Vide Mah. Act 31 of 1989, S. 7.)
1 Ins. by Act 68 of 1982, S. 30 (w.e.f. 15-9-1964).
2 Subs. by Act 68 of 1982, S. 40 (w.e.f. 1-2-1983).
Schedule 1
1[THE FIRST SCHEDULE [See Section 3(a)]
A.- 2[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 | Bharat Bhaishajya Ratnakara | ||
| 11 | Bhava Prakasha | ||
| 12 | Brihat Nighantu Ratnakara | ||
| 13 | Charaka Samhita | ||
| 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 I] | ||
| 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 | Sarvaroga 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 | Vaidya Jiwan | ||
| 39 | Basava Rajeeyam | ||
| 40 | Yoga Ratnakara | ||
| 41 | Yoga Tarangini | ||
| 42 | Yoga Chintamani | ||
| 43 | Kashyapasamhita | ||
| 44 | Bhelasamhita | ||
| 45 | Vishwanathachikitsa | ||
| 46 | Vrindachikitsa | ||
| 47 | Ayurvedachintamani | ||
| 48 | Abhinavachintamani | ||
| 49 | Ayurveda-ratnakar | ||
| 50 | Yogaratnasangraha | ||
| 51 | Rasamrita | ||
| 52 | Dravyagunanighantu | ||
| 53 | Rasamanjari | ||
| 54 | Bangasena | ||
| 4[54-A | Ayurvedic Formulary of India 5[***] | ||
| 6[***]54-B | Ayurveda Sara Samgraha] | ||
| 7[54-C | Ayurvedic Pharmacopoeia of India] | ||
| 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 (500) | ||
| 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 Siddhar's Chillari Kovai | ||
| 72 | Yogi Vatha Kaviyam | ||
| 73 | Therayar Tharu | ||
| 74 | Agasthiyar Vaidya Kaviyam (1500) | ||
| 75 | Bala Vagadam | ||
| 76 | Chimittu Rathna (Rathna) Churukkam | ||
| 77 | Nagamuni (200) | ||
| 78 | Agasthiyar Chillari Kovai | ||
| 79 | Chikicha Rathna Deepam | ||
| 80 | Agasthiyar Nayana Vidhi | ||
| 81 | Yugi Karisal (151) | ||
| 82 | Agasthiya r Vallathi (600) | ||
| 83 | Th eray ar Thaila Varkam | ||
| 8[84 | Siddha Formular y of In dia (Part I)] | ||
| B.- 9[UNANI TIBB SYSTEM] | |||
| 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 | ||
| 1310[13 | National Formulary of Unani Medicine (Part I)] |
1 Subs. by Act 13 of 1964, S. 31, for the Schedule, First Schedule came into force w.e.f. 1-2-1969 and the Second Schedule came into force (w.e.f. 15-9-1964).
2 Subs. for "Ayurvedic (including Siddha) System" by Act 68 of 1982, S. 41 (w.e.f. 1-2-1983).
3 Subs. by Noti. No. 658(E), dt. 31-8-1994.
4 Ins. by GSR 735(E), dt. 28-8-1987.
5 The brackets, word and figure "(Part I)" omitted by GSR 423(E), dt. 11-6-2002.
6 The brackets, word and figure "(Part I)" omitted by GSR 423(E), dt. 11-6-2002.
7 Ins. by GSR 423(E), dt. 11-6-2002.
8 Ins. by GSR 735(E), dt. 28-8-1987.
9 Subs. for "Unani (Tibb) System" by Act 68 of 1982, S. 41 (w.e.f. 1-2-1983).
10 Ins. by GSR 735(E), dt. 28-8-1987.
Schedule 2
THE SECOND SCHEDULE
(See Sections 8 and 16)
STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED
| Class of drug | Standard to be complied with | |
| 1. | Patent or proprietary medicines 1[other than Homoeopathic medicines]. | The formula or list of ingredients displayed in the prescribed manner on the label or container and such other standards as may be prescribed. |
| 22. | [Substances commonly known as vaccines, sera, toxins, toxoids, an titoxins and antigens and biological products of like nature, for human use or for veterinary use. | The standards maintained at the International Laboratory for Biological Standards, Stantans Serum Institute, Copenhagen, and at the Central Veterinary Laboratory, Weybridge, Surrey, U.K., and such other laboratories re cognised by the World Health Organisation from time to time, and such further standards of strength, quality, and purity, as may be prescribed.] |
| 3. | [* * *] 3 | |
| 4. | Substances (other than food) intended to affect the 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. | Such standards as may be prescribed. |
| 44-A. | [Homoepathic medicines: | |
| (a) | Drugs included in the Homoeopathic Pharmacopoeia of India. | Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as m ay be prescribed. |
| (b) | Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic Pharmacopoeia of the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoei a. | Standards of identity, purity and strength prescribed for the drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed. |
| (c) | Drugs not included inthe Homoeopathic Pharmacopoeia of India or the United States of America, or the United Kingdom or the German Homoeopathic Pharmacopoeia. | The formula or list of ingredients displayed in the prescri bed manner on the label of the container and such other standards as may be prescribed by the Central Government.] |
| 5[5. | Oher 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 editi on of the Indi an Pharmacopoei a for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards of identity, | ||
| Class of drug | Standard to be complied with for 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 Pharmacopoeia but which are included in the official Pharmacopoeia of any other country. | Standards of identity, purity and strength specified for drugs in the edition of such official Pharmacopoeia of any othe rcountry 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 Pharma copoeia 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 edition of such official Pharmacopoeia and such other standards as may be prescribed.] |
1 Ins. by S.O. 887, dt. 19-3-1966, Gaz. of India, Pt. II, Sec. 3(ii), p. 819.
2 Subs. by GSR 299(E), dt. 23-4-1984.
3 Omitted by GSR 299(E), dt. 23-4-1984.
4 Subs. by G.S.R. 820, dt. 6-6-1978, pub. in Gaz. of India, Pt. II, Sec. 3(i), dt. 24-6-1978, p. 1471.
5 Subs. by G.S.R. 885 of 1973, dt. 4-8-1973.
(12)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 444(E), dated April 30, 1992, published in the Gazette of India, Extra., Part II, Section 3(i), dated 30th April, 1992, p. 2, Sl. No. 192 [No. X. 11014/3/91-DMS & PFA]
Whereas the Central Government is satisfied on the basis of evidence and other material available before it that the use of tobacco in toothpastes/tooth-powders is likely to involve risk to human beings and that it is necessary and expedient in the public interest so to do.
Now, therefore, in exercise of powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture and sale of all cosmetics licensed as toothpastes/tooth-powders containing tobacco.
(23)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 443(E), dated April 30, 1992, published in the Gazette of India, Extra., Part II, Section 3(i), dated 30th April, 1992, p. 2, Sl. No. 191 [No. X. 11014/3/91-DMS & PFA]
Whereas the Central Government is satisfied on the basis of evidence and other material available before it that the use of tobacco in toothpastes/tooth-powders is likely to involve risk to human beings and that it is necessary and expedient in the public interest so to do;
Now, therefore, in exercise of powers conferred by Section 33-EED of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibit the manufacture and sale of all Ayurvedic Drugs licensed as toothpastes/tooth-powders containing tobacco.
(3)
Noti. No. SO 701, dated 24th March, 1961, published in the Gazette of India, Extra., Part II, Section 3(ii), p. 725
In pursuance of clause (h) of Section 3 of the Drugs Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby authorises the following pharmacopoeias for the purposes of clause (h) of the section, namely:
The Indian Pharmacopoeia, the pharmacopoeia of United States, the National Formulary of the United States, the International pharmacopoeia and the State Pharmacopoeia of the Union of Soviet Socialist Republics.
(1)
Noti. No. SO 2666, dated October 28, 1960, published in the Gazette of India, Extra., Part II, Section 3(ii), p. 381
In exercise of the powers conferred by sub-clause (ii) of clause (b) of Section 3 of the Drugs Act, 1940 (23 of 1940), the Central Government hereby specifies as drugs the following substances, namely:
"Disinfectants-Coal Tar Disinfectant fluids, black and white".
(22)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. G.S.R. 677(E), dated September 15, 2009, published in the Gazette of India, Extra., Part II, Section 3(i), dated 15th September, 2009, p. 2, No. 534
Whereas, the Central Government is satisfied that the drugs ‘Oseltamivir Phosphate’ and ‘Zanamivir’ are essential to meet the requirements of emergency arising due to epidemic and in public interest, and it is necessary and expedient to regulate and restrict the manufacture, sale and distribution of the drugs ‘Oseltamivir Phosphate’ and ‘Zanamivir’ and preparations based thereon and for preventing their misuse;
Now, therefore, in exercise of the powers conferred by Section 26-B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby directs that no person shall manufacture for sale or for distribution, or sell or stock, or exhibit or offer for sale, or distribute any preparation containing the drug ‘Oseltamivir Phosphate’ or ‘Zanamivir’ except in the manner specified below, namely:-
(a) no person shall himself or by any other person on his behalf manufacture for sale or for distribution without the prior approval in writing from the Drugs Controller (India);
(b) the conditions specified in the Drugs and Cosmetics Rules, 1945 in respect of the drugs specified under Schedule X to that rules shall apply to the drugs ‘Oseltamivir Phosphate’ and ‘Zanamivir’ or any preparation based thereon;
(c) no manufacturer, distributor, stockist, dealer or any other person licensed to sell the drugs shall sell or supply in India any preparation containing the drug ‘Oseltamivir Phosphate’ and ‘Zanamivir’ except to the Central Government or a State Government or Union Territory Administration or hospitals or nursing homes or such other agency or agencies as the Government may, by order in writing, designate:
Provided that the export of the drug ‘Oseltamivir Phosphate’ and ‘Zanamivir; or any preparation based thereon may be allowed by the Drugs Controller (India) in consultation with the Central Government:
Provided further that any dealer who has the licence to sell, stock or distribute drugs specified under Schedule X to the Drugs and Cosmetics Rules, 1945 may sell the said drugs and shall maintain records for such sales;
(d) every manufacturer of the drug ‘Oseltamivir Phosphate’ and ‘Zanamivir’ or any preparation based thereon shall submit to the Drugs Controller (India) a monthly statement, containing therein the quantity of such drugs supplied by them to distributors, stockists, dealers by the end of every month;
(e) every distributor, stockist and dealer holding stocks of ‘Oseltamivir Phosphate’ and ‘Zanamivir’ or any preparation based thereon shall submit to the concerned licensing authority in the State or Union territory, as the case may be, a monthly statement, containing therein the quantity of such drugs available with them, by the end of every month;
(f) the Central Government, State Governments or the Union Territory administrations shall make arrangements for the distribution of ‘Oseltamivir Phosphate’ and ‘Zanamivir’ and preparations based thereon through the public health systems, as it may consider appropriate.
2. This order shall come into force on the date of its publication in the Official Gazette.
(17)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 191(E), dated March 5, 2003, published in the Gazette of India, Extra., Part II, Section 3(i), dated 5th March, 2003, p. 2, No. 109 [F. No. X. 11014/7/2002-DMS & PFA]
Whereas the Central Government is satisfied that the use of drug formulations containing Astemizole and/or Terfinadine are likely to involve certain risks and whereas safer alternatives of these drugs are available.
And whereas the Central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of these drugs in public interest.
Now, therefore, in exercise of powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby makes the following amendment in the Notification of the Government of India in the Ministry of Health and Family Welfare, Noti. No. GSR 732(E), dated 29th October, 2002, namely:-
In the said notification, in the third para, for the words and figures ". . . prohibits the manufacture, sale and distribution of the following drugs for human use with effect from 1st August, 2003:-
1. Astemizole
2. Terfinadine".
the following words and figures shall be substituted, namely:-
"Prohibits the manufacture of the following drugs for human use with immediate effect and sale and distribution thereof with effect from 1st April, 2003, namely:-
1. Astemizole
2. Terfinadine."
(5)
Ministry of Law, Justice and Company Affairs (Deptt. of Company Affairs), Noti. No. GSR 390(E), dated April 18, 1994, published in the Gazette of India, Extra., Part II, Section 3(i), dated 18th April, 1994, p. 2 Sl. No. 167 [F. No. 3/7/87-CL.V]
In continuation of Notification No. GSR 219(E), dated the 18th April, 1991 and in exercise of the powers conferred by sub-section (1) of Section 294-AA of the Companies Act, 1956 (1 of 1956), the Central Government being of the opinion that the demand for the category of goods specified in the Table below is substantially in excess of the production or supply of such goods and that the services of the Sole Selling Agents will not be necessary to create a market for such goods, hereby declares that Sole Selling Agents shall not be appointed by any company for the sale of such goods in India for a further period of three years from the date of publication of this notification in the Official Gazette.
TABLE
Every category of "bulk drug", "drugs" and "formulations" as defined in the Drugs (Prices Control) Order, 1987 not being:-
(i) any bona fide preparation included in the Ayurvedic (including Siddha) or Unani (Tibb) systems of medicine; or
(ii) any preparation included in the Homoeopathic system of medicine.
(19)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 810(E), dated December 13, 2004, published in the Gazette of India, Extra., Part II, Section 3(i), dated 15th December, 2004, p. 1, No. 551 [F. No. X.-11014/7/2004-DMS & PFA]
Whereas the Central Government is satisfied that use of drug formulations containing Rofecoxib are likely to involve certain risk to human beings;
And whereas safer alternatives to the drug are available;
And whereas the Central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of this drug in public interest;
Now, therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect, namely:-
"Rofecoxib and its formulations for human use.".
(4)
Noti. No. 1-20/60-D, dated 3rd June, 1961 as amended by Noti. No. F. 1-20/60-D, dated 29th September, 1962; F. 1-49/68-D, dated 11th June, 1969 and Noti. No. X.11013/2/72-D, dated 9th July, 1975
In exercise of the powers conferred by sub-clause (ii) of clause (b) of Section 3 of the Drugs Act, 1940 (23 of 1940), the Central Government in supersession of the notifications of the Government of India in the Ministry of Health No. F. 1-10/56-D, dated the 20th October, 1956, F. 1-40/59-D, dated the 2nd April, 1960 and No. F. 1-50/59-D, dated the 15th June, 1960, hereby specifies as drugs the following substances, namely:-
1. Contraceptives.
2. Disinfectants
(1) Disinfectant fluids made from Coaltar Oils, Coaltar acids or similar acids derived from petroleum with or without hydrocarbons.
(2) Disinfectant fluids made from synthetic or naturally occurring substances other than those mentioned in (1) above by virtue of their composition possessing disinfectant properties or with claim to possess disinfectant properties.
(2)
Noti. No. SO 1335, dated June 2, 1961, published in the Gazette of India, Extra., Part II, Section 3(ii), p. 1261
In exercise of the powers conferred by sub-clause (ii) of clause (b) of Section 3 of the Drugs Act, 1940, the Central Government in supersession of the notification of the Government of India in the Ministry of Health No. F. 1-10/59-D, dated the 20th October, 1956, F. 1-40/59-D, dated the 22nd April, 1960, and No. F. 1-50/50-D, dated the 15th June, 1960, hereby specifies as drugs the following substances, namely:
1. Contraceptives
2. Insecticides-
(1) Dichophane (Dichlore Diphenyl Trichloroethane) and its preparations.
(2) Pyrethrum and its preparations.
(3) Benzene Hexachloride and its preparations.
(4) Dieldrin and its preparations.
3. Disinfectants-
Coal Tar Disinfectant fluids, black and white.
(24)
Ministry of Health and Family Welfare [Deptt. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (Ayush)], Noti. No. GSR 701(E), dated December 1, 2005, published in the Gazette of India, Extra., Part II, Section 3(i), dated 2nd December, 2005, p. 1, No. 491 [No. A. 11012/1/2005-DCC(AYUSH)]
In exercise of the powers conferred by sub-section (i) of Section 33-F of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby appoints Director, Pharmacopoeial Laboratory for Indian Medicines, Ghaziabad as Government Analyst for the whole of India in respect of Ayurvedic, Siddha and Unani medicines.
(7)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. S.O. 1468(E), dated October 6, 2005, published in the Gazette of India, Extra., Part II, Section 3(ii), dated 6th October, 2005, p. 1, No. 1077 [F. No. 11014/2/2005-DMS&PFA]
In pursuance of the sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following sterile devices intended for external or internal use in human beings as drugs with immediate effect, namely:-
| (i) (ii) (iii) (iv) (v) | Cardiac Stents Drug Eluting Stents Catheters Intra Ocular Lenses I.V. Cannulae | (vi) (vii) (viii) (ix) (x) | Bone Cements Heart Valves Scalp Vein Set Orthopaedic Implants Internal Prosthetic Replacements |
(20)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 510(E), dated July 28, 2005, published in the Gazette of India, Extra., Part II, Section 3(i), dated 28th July, 2005, p. 1, No. 333 [F. No. 11014/1/2005-DMS & PFA]
Whereas the Central Government is satisfied that use of drug formulations containing Valdecoxib are likely to involve certain risk to human beings;
And, whereas safer alternative to the drug are available;
And, whereas the Central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of this drug in public interest;
Now, therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect, namely:-
"Valdecoxib and its formulations for human use.".
(13)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 93(E), dated February 25, 1997, published in the Gazette of India, Extra., Part II, Section 3(i), dated 25th February, 1997, p. 1, Sl. No. 78 [No. X-11014/5/96-DMS & PFA]
Whereas the Central Government is satisfied that the use of the fixed dose combination of streptomycin and penicillins does not have therapeutic value claimed or purported to be claimed for them;
And whereas it is necessary and expedient to prohibit the manufacture, sale and distribution of the said combination of streptomycin and penicillins in the public interest;
And whereas the Supreme Court of India in the case of W.P. (Civil)/No. 698 of 1993, Drug Action Forum v. Union of India have considered it appropriate that the time for phasing out the fixed dose combination of streptomycin and penicillins injection from the market should be fixed up to the 1st January, 1998;
Now, therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture and sale of parenteral preparations containing fixed dose combination of streptomycin with penicillins with effect from 1st January, 1998.
(15)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 814, dated December 16, 1999, published in the Gazette of India, Extra., Part II, Section 3(i), dated 16th December, 1999, p. 1, No. 605 [F. No. X-11014/5/99-DMS & PFA]
Whereas the Central Government is satisfied that the use of the drugs specified below do not have the therapeutic value claimed or purported to be claimed for them or contain ingredients in such quantity for which there is no therapeutic justification and that in the public interest it is necessary and expedient to prohibit the manufacture, sale or distribution of the said drugs;
Now, therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale or distribution of the said drugs for human use with effect from 1st September, 2000;
(1) Fixed dose combination of haemoglobin in any form (natural or synthetic).
(2) Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme.
(14)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 702(E), dated October 14, 1999, published in the Gazette of India, Extra., Part II, Section 3(i), dated 14th October, 1999, pp. 1-2, [No. X. 11014/6/99-DMS & PFA]
Whereas the Central Government is satisfied that the use of the Fixed Dose Combination of Vitamin B1, Vitamin B6, Vitamin B12 does not have the therapeutic value claimed or purported to be claimed for it;
And whereas it is necessary and expedient to prohibit the manufacture, sale or distribution of the said combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use in public interest;
Now, therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale or distribution of Fixed Dose Combination of Vitamin B1, Vitamin B6, and Vitamin B12 for human use with effect from 1st January, 2001.
(18)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 780(E), dated October 1, 2003, published in the Gazette of India, Extra., Part II, Section 3(i), dated 1st October, 2003, p. 1, No. 479 [F. No. X. 11014/2/2003-DMS & PFA]
Whereas the Central Government is satisfied that the use of drug formulations containing Phenformin is likely to involve risk to human beings and is no longer considered therapeutically justified;
And whereas the Central Government is satisfied that better alternatives to the drug formulations containing Phenformin are now available;
And whereas the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the drug formulations aforesaid;
Now therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale or distribution of Phenoformin for human use.
This notification shall take effect from the 1st day of October, 2003.
(10)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. S.O. 3309(E), dated December 30, 2009, published in the Gazette of India, Extra., Part II, Section 3(ii), dated 30th December, 2009, p. 2, No. 2209 [F. No. X-11014/02/2009-DFQC]
In exercise of the powers conferred by sub-section (2) of Section 20 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, in addition to the Notification Number S.O. 878(E), dated the 23rd June, 2005, hereby appoints:-
1. Shri P.K. Guha, Director, Central Drugs Laboratory, Kolkata
2. Shri C. Hariharan, Bacteriologist, Central Drugs Laboratory, Kolkata
3. Dr. Saroj Kumar Ghosh, Biochemist, Central Drugs Laboratory, Kolkata
4. Dr. Nandita Saha, Associate Pharmaceutical Chemist, Central Drugs Laboratory, Kolkata
5. Dr. Anjan Pal, Associate Baehteriologist, Central Drugs Laboratory, Kolkata
6. Dr. Subir Kumar Basu, Technical Officer (Bacteriologist), Central Drugs Laboratory, Kolkata
7. Dr. Kajal Datta, Assciate Biochemist, Central Drugs Laboratory, Kolkata
at the Central Drugs Laboratory, Kolkata, to be Government Analysts, for the whole of India in respect of the following classes of drugs, namely:-
All classes of drugs except the classes of drugs mentioned below, namely-
| (1) | Sera | (7) | Sterilized surgical ligature and sterilized surgical suture |
| (2) | Solution of Serum Proteins intended for Injection | (8) | Bacteriophages |
| (3) | Vaccines | (9) | Anti-sera for veterinary use |
| (4) | Toxins | (10) | Vaccines for veterinary use |
| (5) | Antigens | (11) | Toxoids for veterinary use |
| (6) | Anti-toxins | (12) | Diagnostic Antigens for veterinary use |
| (13) | VDRL Antigen. |
(21)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 499(E), dated July 4, 2008, published in the Gazette of India, Extra., Part II, Section 3(i), dated 5th July, 2008, p. 1, No. 364 [F. No. X-11014/6/2007-DFQC]
Whereas the Central Government is satisfied that the use of drug formulations containing Diclofenac are likely to involve risk to animals;
And, whereas, safer alternative to the said drug is available;
And, whereas, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of Diclofenac and its formulations for animal use;
Now, therefore, in exercise of powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect, namely:-
"Diclofenace and its formulations for animal use".
(6)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 365(E), dated March 17, 1989, published in the Gazette of India, Extra., Part II, Section 3(i), dated 17th March, 1989, p. 2 [No. X. 11014/8/88-DMS & PFA]
In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government hereby specify the following devices, after consultation with the Drugs Technical Advisory Board, as drugs with immediate effect:-
(i) Disposable Hypodermic Syringes.
(ii) Disposable Hypodermic needles.
(iii) Disposable Perfusion sets.
1[(iv) In vitro diagnostic devices for HIV, Hbs Ag & HCV.]
1 Ins. by GSR 601(E), dt. 27-8-2002 (w.e.f. 1-9-2002).
(8)
Ministry of Health and Family Welfare, Noti. No. GSR 577(E), dated July 23, 1983, published in the Gazette of India, Extra., Part II, Section 3(i), dated 23rd July, 1983, p. 2, Sl. No. 275 [No. X. 11014/1/83-DMSO & PFA]
Whereas the Central Government is satisfied that the use of the drugs specified in the Table below is likely to involve risk to human beings or animals and it is necessary and expedient in the public interest so to do.
Now, therefore, in exercise of powers conferred by Section 10-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the import into India of the said drugs, namely:-
TABLE
| (1) | Nialamide. | 2[(7) | Chloral Hydrate as a drug.] |
| (2) | Practolol. | 3[(8) | Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception. |
| (3) | Amidopyrine. | (9) | Fenfluramine and Dexfenfluramine.] |
| (4) | Phenacetin. | 4[(10) | Rimonabant.] |
| (5) | Methapyrilene, and its salts. | ||
| 1[(6) | Methaqualone.] |
1 Ins. by GSR 48(E), dt. 31-1-1984.
2 Ins. by GSR 303(E), dt. 7-6-1991.
3 Ins. by GSR 498(E), dt. 14-8-1998.
4 Ins. by GSR 884(E), dt. 11-12-2009.
(9)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. S.O. 254(E), dated January 22, 2009, published in the Gazette of India, Extra., Part II, Section 3(ii), dated 22nd January, 2009, p. 1, No. 145 [No. X-11014/3/2008-DFQC]
In exercise of the powers conferred by sub-section (2) of Section 20 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby appoints Dr N. Murugesan, Director in charge, the Central Drugs Testing Laboratory, Chennai to be Government Analysts for the whole of India in respect of the following classes of drugs, namely:-
Rubber latex condoms, cosmetics and all classes of drugs, including Schedule C and C(1) drugs except those mentioned below, namely:-
| (1) | Sera | (7) | Sterilized surgical ligature and sterilized surgical suture |
| (2) | Solution of Serum Proteins intended for Injection | (8) | Bacteriophages |
| (3) | Vaccines | (9) | Anti-sera for veterinary use |
| (4) | Toxins | (10) | Vaccines for veterinary use |
| (5) | Antigens | (11) | Toxoids for veterinary use |
| (6) | Anti-toxins | (12) | Diagnostic Antigens for veterinary use |
(16)
Ministry of Health and Family Welfare (Deptt. of Health), Noti. No. GSR 170(E), dated March 12, 2001, published in the Gazette of India, Extra., Part II, Section 3(i), dated 12th March, 2001, p. 2
Whereas the Central Government is satisfied that the use of the drugs specified below do not have the therapeutic value claimed or purported to be claimed for them or the said drugs contain ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary and expedient to prohibit the manufacture, sale and distribution of the said drugs;
Now, therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the said drugs for human use with effect from 1st January, 2002.
1. Fixed dose combination of Nitrofurantoin and Trimethoprim.
2. Fixed dose combination of Phenobarbitone with any anti-asthamatic drugs.
3. Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine.
4. Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona.
5. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propentheline Bromide.
6. Fixed dose combination of Nalidixic acid with any anti-amoebics including Metronidazole.
7. Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
8. Fixed dose combination of Cyproheptadine with Lysine or Peptone.
(11)
Ministry of Health and Family Welfare, Noti. No. GSR 578(E), dated July 23, 1983, published in the Gazette of India, Extra., Part II, Section 3(i), dated 23rd July, 1983, p. 2, Sl. No. 276 [No. X. 11014/1/83-DMS & PFA]
Whereas the Central Government is satisfied that the use of the drugs specified in the Table below is likely to involve risk to human beings or the said drugs do not have the therapeutic value claimed or purported to be claimed for them or contain ingredients and in such quantity for which there is no therapeutic justification and it is necessary and expedient in the public interest so to do.
Now, therefore, in exercise of powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture and sale of the said drugs, namely:-
TABLE
1. Amidopyrine.
2. Fixed dose combinations of Vitamins with anti-inflammatory agents and tranquillisers.
3. Fixed dose combinations of Atropine in Analgesics and Antipyretics.
4. Fixed dose combinations of Strychnine and Caffeine in tonics.
5. Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.
6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
7. Fixed dose combinations of Sodium Bromide/Chloral hydrate with other drugs.
8. Phenecatin.
9. Fixed dose combinations of anti-histaminics with anti-diarrhoeals.
10. Fixed dose combinations of Penicillin with Sulphonamides.
11. Fixed dose combinations of Vitamins with Analgesics.
12. Fixed dose combinations of Tetracycline with Vitamin C.
1[13. Fixed dose combination of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.]
2[14. Fixed Dose combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.]
3[15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.]
4[16. Fixed dose combination of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.]
17. Fixed dose combinations of Vitamins with anti-T.B. drugs except combination of Isoniazide with Pyridoxine Hydrochloride (Vitamin B-6).
18. Penicillin skin/eye ointment.
19. Tetracycline liquid oral preparations.
20. Nialamide.
21. Practolol.
22. Methapyrilene, its salts.
5[23. Methaqualone.]
6[24. Oxytetracycline Liquid Oral Preparations.
25. Demeclocycline Liquid Oral Preparations.]
7[26. Combination of Anabolic Steroids with other drugs.]
8[27. Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyle Estradiol) and of progestin content of more than 3 mg. (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic oestrogen and progesterone.]
9[28. Fixed dose combination of Sedatives/hypnotics/anxiolytics with analgesic - antipyretics.
10[29. Fixed dose combination of Rifampicin, Isoniazid and Pyrazinamide, except those which provide daily adult dose given below:-
| Drugs | Minimum | Maximum |
| Rifampicin | 450 mg. | 600 mg. |
| Isoniazid | 300 mg. | 400 mg. |
| Pyrazinamide | 1000 mg. | 1500 mg.] |
30. Fixed dose combination of Histamine H2-receptor antagonists with antacids except for those combinations approved by the Drugs Controller, India.
31. The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.
32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.]
11[33. Fixed dose combination of Ethambutol with INH other than the following:
| INH | Ethambutol |
| 200 mg. | 600 mg. |
| 300 mg. | 800 mg. |
34. Fixed dose combination containing more than one antihistamine.
35. Fixed dose combination of anthelmintic with cathetric/purgative except for piperazine.
12[36. Fixed dose combination of Salbutamol or any other drug having primarily bronchodilatory activity with centrally acting anti-tussive and/or antihistamine.]
37. Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.
13[38. Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/Paracetamol.]
39. Fixed dose combination of centrally acting, anti-tussive with antihistamine having high atropine like activity in expectorants.
40. Preparations claiming to combat cough associated with asthma containing centrally acting anti-tussive and/or an antihistamine.
41. Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and/or central nervous system stimulant and such preparations containing alcohol more than 20% proof.
42. Fixed dose combination containing Pectin and/or Kaolin with any drug which is systematically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systematically absorbed.]
14[43. Chloral Hydrate as a drug.]
15[44. Dover's Powder I.P.
45. Dover's Powder Tablets I.P.]
16[46. Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
47. Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
48. Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
49. Liquid Oral antidiarrhoeals or any other dosage form for paediatric use containing Diphenoxylate or Loperamide or Atropine or Belladonna including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
50. Liquid oral antidiarrhoeals or any other dosage form for paediatric use containing halogenated hydroxyquinolines.
51. Fixed dose combination of antidiarrhoeals with electrolytes.]
17[52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:
(a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:-
Sodium-50 to 90 millimoles.
Total osmolarity-240-290 milliosmoles.
Dextrose: Sodium molar ratio-Not less than 1: 1 and not more than 3: 1.
(b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain:-
Sodium-50 to 90 millimoles.
Total osmolarity-Not more than 290 milliosmoles.
Precooked rice-Equivalent to not less than 50 gms and not more than 80 gms as total replacement of Dextrose.
(c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salts conforming to the parameters specified above and labelled with the indication for "Adult Choleratic Diarrhoea only".
(d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharine sweetening agent.]
18[53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
54. Fixed dose combination of Analgin with any other drug.19[* * *]
55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steroidal anti-inflammatory drugs (NSAIDs).
56. Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.]
20[57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
58. Fenfluramine and Dexfenfluramine.]
21[59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.]
22[60. Rimonabant.]
1 Subs. by Noti. No. GSR 793(E), dt. 13-12-1995.
2 Subs. by Noti. No. GSR 738(E), dt. 9-10-2009.
3 Subs. by Noti. No. 1057(E), dt. 31-11-1988.
4 Subs. by Noti. No. 304(E), dt. 7-6-1991.
5 Ins. by GSR 49(E), dt. 31-1-1984.
6 Ins. by GSR 322(E), dt. 3-5-1984.
7 Ins. by GSR 863(E), dt. 22-11-1985.
8 Subs. by Noti. No. 743(E), dt. 10-8-1989.
9 Ins. by GSR 999(E), dt. 26-12-1990.
10 Subs. by GSR 100(E), dt. 11-2-2003.
11 Ins. by GSR 69(E), dt. 11-2-1991.
12 Subs. by G.S.R. 290(E), dt. 16-4-2008.
13 Subs. by GSR 603(E), dt. 24-8-2001 (w.e.f. 1-9-2002).
14 Ins. by GSR 304(E), dt. 7-6-1991.
15 Ins. by Noti. No. 111(E), dt. 22-2-1994 as corrected by GSR 612(E), dt. 9-8-1994.
16 Ins. by Noti. No. 731(E), dt. 30-9-1994.
17 Ins. by GSR 57(E), dt. 7-2-1995.
18 Ins. by GSR 633(E), dt. 13-9-1995 as corrected by GSR 123(E), dt. 11-3-1996 and GSR 230(E), dt. 4-6-1996.
19 Words "other than antispasmodics" omitted by GSR 405(E), dt. 3-6-1999.
20 Ins. by GSR 499(E), dt. 14-8-1998.
21 Ins. by GSR 169(E), dt. 12-3-2001. Prior to this entries 59 and 60 were inserted by GSR 590(E), dt. 17-8-1999 but omitted by GSR 704(E), dt. 20-10-1999. They read as follows:
"59. Fixed Dose Combination of haemoglobin in any form (natural or synthetic).
60. Fixed Dose Combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme."
22 Ins. by GSR 885(E), dt. 11-12-2009.