Such stocks of drugs as may be in the possession of licensee, on the expiry or cancellation or surrender of his licence, shall be disposed of in such manner as may be specified by the Narcotics Commissioner in this behalf.
34[Chapter V-A
POSSESSION, TRANSPORT, IMPORT INTER-STATE, EXPORT INTER-STATE, SALE, PURCHASE, CONSUMPTION AND USE OF ESSENTIAL NARCOTIC DRUGS
52-A. Possession of essential narcotic drug. (1) No person shall possess any essential narcotic drug otherwise than in accordance with the provisions of these rules.
(2) Any person may possess an essential narcotic drug in such quantity as has been at one time sold or dispensed for his use in accordance with the provisions of these rules.
(3) A registered medical practitioner may possess essential narcotic drug, for use in his practice but not for sale or distribution, not more than the quantity mentioned in the Table below, namely
TABLE
| Sl. No. |
Name of the essential narcotic drug |
Quantity |
| (1) |
(2) |
(3) |
| 1. |
Morphine and its salts and all preparations containing more than 0.2 per cent of Morphine |
500 Milligrammes |
| 2. |
Methyl morphine (commonly known as Codeine ) and Ethyl morphine and their salts (including Dionine), all dilutions and preparations except those which are compounded with one or more other ingredients and containing not more than 100 milligrammes of the drug per dosage unit and with a concentration of not more than 2.5% in undivided preparations and which have been established in therapeutic practice |
2000 Milligrammes |
| 3. |
Dihydroxy Codeinone (commonly known as Oxy-codone and Dihydroxycodeinone), its salts (such as Eucodal Boncodal Dinarcon Hydrolaudin, Nucodan, Percodan, Scophedal, Tebodol and the like), its esters and the salts of its ester and preparation, admixture, extracts or other substances containing any of these drugs |
250 Milligrammes |
| 4. |
Dihydrocodeinone (commonly known as Hydrocodone), its salts (such as Dicodide, Codinovo, Diconone, Hycodan, Multacodin, Nyodide, Ydroced and the like) and its esters and salts of its ester, and preparation, admixture, extracts or other substances containing any of these drugs |
320 Milligrammes |
| 5. |
1-phenethyl-4-N-propionylanilino-piperidine (the international non-proprietary name of which is Fentanyl) and its salts and preparations, admixture, extracts or other substances containing any of these drugs |
Two transdermal patches one each of 12.5 microgram per hour and 25 microgram per hour: |
Provided that the Controller of Drugs or any other officer authorised in this behalf by him may by special order authorise, in Form 3-B, any such practitioner to possess the aforesaid drugs in quantity larger than as specified in the above Table:
Provided further that such authorisation may be granted or renewed, for a period not exceeding three years at a time.
Explanation. The expression for use in his practice covers only the actual direct administration of the drugs to a patient under the care of the registered medical practitioner in accordance with established medical standards and practices.
(4) For renewal of the authorisation referred to in the second proviso to sub-rule (3), application shall be made to the Controller of Drugs at least thirty days before the expiry of the previous authorisation.
(5)(a) The Controller of Drugs may, by order, prohibit any registered medical practitioner from possessing for use in his practice under sub-rule (3) any essential narcotic drug, where such practitioner
(i) has violated any provision of these rules; or
(ii) has been convicted of any offence under the Act; or
(iii) has, in the opinion of the Controller of Drugs, abused such possession or otherwise been rendered unfit to possess such drug.
(b) When any order is passed under clause (a) of this sub-rule, the registered medical practitioner concerned shall forthwith deliver to the Controller of Drugs the essential narcotic drug then in his possession and the Controller of Drugs shall issue orders for the disposal of such drugs.
(6) The Controller of Drugs may, by a general or special order, authorise any person to possess essential narcotic drug as may be specified in that order.
(7) A recognised medical institution may possess essential narcotic drug in such quantity and in such manner as specified in these rules.
35[(8) A manufacturer may possess essential narcotic drug in such quantity as may be specified in the licence issued under Rule 36, Rule 36-A, or Rule 37 of these rules or the licence issued for manufacturing the preparations of essential narcotic drugs under the rules made by the State Government under Section 10 of the Act:
Provided that there shall be no limit to the possession of essential narcotic drug by the Government Opium Factories.]
(9) A licenced dealer or a licenced chemist may possess essential narcotic drug in such quantity and in such manner as may be specified in the licence issued under these rules.
52-B. Provisions regarding licenced dealer and licenced chemist. (1) A licenced dealer or a licenced chemist shall apply for a licence to possess, sell, exhibit or offer for sale or distribution by retail or wholesale, essential narcotic drug, to the authority competent to issue licence to possess, sell, exhibit or offer for sale or distribution by retail or wholesale, manufactured drugs under the rules framed under Section 10 of the Act by State Government of the State in which he has his place of business.
(2) Every application for issue of licence referred to in sub-rule (1) shall be in such form and manner as may be specified by the authority referred to in the said sub-rule.
(3) The licence to possess, sell, exhibit or offer for sale or distribution by retail or wholesale, essential narcotic drugs shall have the same conditions as are applicable to a licence to possess, sell, exhibit or offer for sale or distribution by retail or wholesale, manufactured drugs under the rules framed under Section 10 of the Act by the State Government.
(4) The licence under this rule shall be obtained within a period of one hundred and eighty days from the date of commencement of these rules.
52-C. Import Inter-State and Export-Inter-State of essential narcotic drugs. Any person who is permitted to possess essential narcotic drug under Rule 52-A may import inter-State or export inter-State such drug up to the quantity he is permitted to possess.
52-D. Transport of essential narcotic drugs. (1) Subject to the provisions of Rule 52-C, no consignment of essential narcotic drugs shall be transported, imported inter-State or exported inter-State unless such consignment is accompanied by a consignment note in Form No. 3-C and in the manner as provided in sub-rules (2) and (3).
(2) The consignment note referred to in sub-rule (1) shall be prepared in triplicate, and the original and duplicate copies of the said note shall be sent along with the consignment of essential narcotic drugs to the consignee who shall return the duplicate copy of the note to the consignor for his use after endorsing on the original and duplicate copies, the particulars of the receipt of the quantity consigned.
(3) The consignor and consignee shall preserve such consignment note referred to in sub-rule (1) for a period of two years:
Provided that the said consignment note shall not apply in cases where the sale of the essential narcotic drug is accompanied by a sale bill or invoice or cash memo or any other document duly signed by the consignor or his authorised signatory, which shall include the following information about the consignment
(a) name, address and licence number of the consignor and the consignee;
(b) description, batch number and quantity;
(c) mode and particulars of transport:
Provided further that such documents shall be preserved by the consignor and consignee for a period of two years.
Explanation. Where the consignee is a person to whom the essential narcotic drug has been sold or dispensed for his personal use, research institution, registered medical practitioner, recognised medical institution, or hospital, the requirement of incorporating licence number of the consignee shall not be applicable.
52-E. Transmission of essential narcotic drugs by post, courier, rail or road. The transmission of essential narcotic drugs by inland post or courier or by rail or by road by a manufacturer, licensed dealer or licensed chemist is permitted, subject to the following conditions, namely
(i) the parcel of the essential narcotic drugs when sent by post shall be sent by registered post;
(ii) the parcel of essential narcotic drugs shall be accompanied by a declaration showing the names of consignor and consignee, the contents of the parcel in detail, the number of licence or authorisation or recognition held by the consignee;
(iii) the consignee shall show distinctly in his account books, if he is a licencee, the name of the consignee and the consignor respectively, and the quantity of the essential narcotic drug imported inter-State, exported inter-State or transported by and to him, as the case may be, from time to time, by post or by courier or by road or by rail.
52-F. Sale. 36[(1) A manufacturer or licenced dealer shall sell essential narcotic drugs otherwise than on prescription to
(a) a manufacturer who has been issued a licence under Rule 37 of these rules or a manufacture of preparations of essential narcotic drugs who has been issued a licence under the rules made by the State Government under Section 10 of the Act;
(b) a licenced dealer;
(c) a licenced chemist;
(d) a registered medical practitioner;
(e) a person who has been authorised by the Controller of Drugs under these rules; or
(f) a recognized medical institution.]
(2) A licenced chemist shall sell essential narcotic drug only on prescription and subject to the provisions of the Drug and Cosmetics Rules, 1945.
(3) A recognised medical institution shall dispense or sell essential narcotic drugs in such manner as specified in these rules.
52-G. Registered medical practitioner and conditions relating to their prescriptions. No prescription for the supply of essential narcotic drugs shall be given by a registered medical practitioner otherwise than in accordance with the following conditions, namely
(i) the prescription shall be in writing, dated and signed by the practitioner with his full name, address and registration number and shall specify the name and address of the person to whom the prescription is given and the total quantity of the essential narcotic drug to be supplied along with daily dose and period of consumption:
Provided that where such drug to be supplied on the prescription is a patent or proprietary medicine, it shall be sufficient to state the quantity and strength of the medicine to be supplied;
(ii) the prescription shall not be given for the use of the prescriber himself.
52-H. Authorisation and accounts. (1) The Controller of Drugs may by a general or special order authorise:
(a) any person in-charge of an educational institution or engaged in scientific research to possess and use, for educational or scientific purposes only, essential narcotic drug, in such quantity and in such manner as may be specified in the said order;
(b) a pilot of an aircraft or captain of a ship to possess and use, on the aircraft or ship, as the case may be, in any emergency, essential narcotic drug, in such quantity and in such manner as may be specified in the said order;
(c) a person in-charge of an ambulance or a first-aid station or a first-aid box to possess and use, in an emergency, essential narcotic drug, in such quantity and in such manner as may be specified in the said order.
(2) Every registered medical practitioner, and a person authorised by general or special order under this rule shall maintain day to day accounts in respect of all transactions of essential narcotic drug in Form No. 3-D and the records of the daily accounts shall be preserved for a minimum period of two years from the date of last entry.
(3) Every registered medical practitioner shall also maintain a separate record in Form No. 3-E for each patient and such record shall be preserved for a minimum period of two years from the date of last entry.
52-I. Suspension and cancellation of authorisation. (1) Without prejudice to any action that may be taken under the provisions of the Act, the Controller of Drugs may, for the reasons to be recorded in writing, cancel or suspend the authorisation under Rules 52-A or 52-H,
(a) if the purpose for which the authorisation was granted ceases to exist; or
(b) in the event of any breach, by the holder of such authorisation or by his servant or by any one acting with his express or implied permission on his behalf, of any of the terms and conditions of such authorisation or of any authorisation previously held by him.
(2) No order shall be passed under sub-rule (1) unless the authorised person has been given a reasonable opportunity of showing cause against the said order or is heard in person, if he so desires.
52-J. Appeal. (1) Appeal against a decision or order made or passed under Rule 52-I may be filed by the person against whom such decision or order has been made or passed, to the Secretary to the State Government responsible for implementation of the Drugs and Cosmetic Rules, 1945 in the State within a period of sixty days from the date of communication of such decision or order to him.
(2) Every memorandum of appeal shall be accompanied by a copy of the decision or order appealed against.
52-K. Procedure for appeal. (1) The Appellate Authority referred to in sub-rule (1) of Rule 52-J shall give an opportunity to the appellant to be heard in person, if he so desires.
(2) The said Appellate Authority may, at the hearing of an appeal allow the appellant to raise any other ground not specified in the appeal, if the Appellate Authority is satisfied that omission of that ground was not wilful or unreasonable.
(3) The aforesaid Appellate Authority may, after making such further inquiry as may be necessary, pass such order as it thinks fit, confirming, modifying or annulling the decision or order appealed against.
(4) The order of the Appellate Authority disposing of the appeal under this rule shall be in writing and shall state the points of determination, the decision thereon and the reasons for the decision.
52-L. Surrender of authorisation, etc. An authorised person, if he so desires, surrender his authorisation by giving not less than fifteen days notice in writing to the issuing authority.
52-M. Disposal of stocks of essential narcotic drugs on expiry, surrender, cancellation of authorisation, etc. (1) Such stocks of essential narcotic drugs as may be in the possession of an authorised person, on the expiry or cancellation or surrender of his authorisation, shall be disposed of in such manner as may be specified by the Controller of Drugs in this behalf.
(2) The expired stock of essential narcotic drugs as may be in the possession of an authorised person or a registered medical practitioner shall be destroyed in such manner as may be specified by the Controller of Drugs.
Chapter V-B
SPECIAL PROVISIONS RELATING TO RECOGNISED MEDICAL INSTITUTION
52-N. Government, etc. hospital, dispensary to be deemed recognised medical institution. Government or Municipal Corporation or Municipal Council or Zila Parishad hospital, dispensary or medical institution, with at least one registered medical practitioner possessing a minimum qualification of a degree in medicine or dentistry and who has undergone training in pain relief and palliative care for prescription of essential narcotic drugs for pain relief and palliative care or training in opioid substitution therapy for prescription of essential narcotic drugs for treatment of opioid dependence, who shall prescribe and dispense essential narcotic drugs, shall be deemed to be a recognised medical institution under these rules for possessing, dispensing or selling of essential narcotic drugs for medical purpose.
Explanation. For the removal of doubts it is hereby clarified that Government or Municipal Corporation or Municipal Council or Zila Parishad hospital, dispensary and medical institution, shall be exempt only from making application to the Controller of Drugs for recognition as recognised medical institution, but all other provisions of this Chapter shall be equally applicable to such deemed recognised medical institution as are applicable to other recognised medical institution.
52-O. Recognition of medical institutions. (1) A medical institution seeking, to be a recognised medical institution or renewal of such recognition, under these rules for possessing, dispensing or selling essential narcotic drugs for medical purposes shall apply in Form No. 3-F to the Controller of Drugs.
(2) The Controller of Drugs, on receipt of application referred to in sub-rule (1) may, subject to any inquiry which may be necessary, issue a Certificate of Recognition in Form No. 3-G and such certificate shall be issued within sixty days from the date of receipt of such application.
(3) In case the Certificate of Recognition is not issued within the period mentioned in sub-rule (2), the Controller of Drugs or any other officer authorised by him in this regard shall inform the applicant the reasons thereof.
(4) The Certificate of Recognition shall be issued for a period not exceeding three years at a time.
(5) For renewal of the recognition referred to in sub-rule (1), application shall be made to the Controller of Drugs at least sixty days before the expiry of previous recognition.
(6) The Certificate of Recognition shall be obtained within a period of one hundred and eighty days from the date of commencement of these rules.
(7) In the event of a change in the constitution of a recognised medical institution, the current recognition shall be deemed to be valid for a maximum period of ninety days from the date on which the change takes place.
52-P. Suspension and Cancellation of recognition. (1) Without prejudice to any action that may be taken under the provisions of the Act, for the reasons to be recorded in writing, the Controller of Drugs may suspend or cancel the recognition referred to in Rule 52-O,
(i) if the essential narcotic drugs obtained by a recognised medical institution were supplied for non-medical use; or
(ii) in the event of any breach of the conditions of the recognition; or
(iii) in the event of violation of any of the provisions of the Act or rules and orders made there under.
(2) No order shall be passed under sub-rule (1) unless the recognised medical institution has been given a reasonable opportunity of showing cause against the said orders or is heard in person, if he so desires.
52-Q. Designated medical practitioner. (1) Every recognised medical institution shall designate one or more registered medical practitioner who has undergone training in pain relief and palliative care for prescription of essential narcotic drugs for pain relief and palliative care or training in opioid substitution therapy for prescription of essential narcotic drugs for treatment of opioid dependence, who shall prescribe and dispense essential narcotic drugs.
(2) When more than one registered medical practitioner is designated, one of them shall be designated as over-all in charge.
(3) The name of the designated medical practitioner or the over-all in charge, as the case may be, shall be endorsed on the Certificate of Recognition issued under rule 52-O by the Controller of Drugs.
(4) Whenever there is a change in the designated medical practitioner or the over-all in charge, as the case may be, the recognised medical institution shall inform the Controller of Drugs within seven days from date of such change for appropriate endorsement on the Certificate of Recognition.
52-R. Duties of designated medical practitioner. (1) The designated medical practitioner or the over-all in charge, as the case may be, shall,
(a) register the patients to whom essential narcotic drugs shall be dispensed or sold for medical use only;
(b) maintain separate record in Form No. 3-E for each patient, which shall be preserved for a minimum period of two years from the date of last entry;
(c) maintain record of all receipts and disbursements of essential narcotic drugs in Form No. 3-H, which shall be preserved for a minimum period of two years from the date of last entry; and
(d) file return for a calendar year on or before the 31st of March of the subsequent year in Form No. 3-I to the Controller of Drugs.
(2) In the event of any change in the constitution of the recognised medical institution, the designated medical practitioner or the over-all in charge, as the case may be, shall inform the Controller of Drugs in writing within thirty days from the date of such change for issue of fresh Certificate of Recognition.
52-S. Surrender of recognition. (1) A recognised medical institution may surrender its recognition by giving not less than thirty days' notice in writing to the Controller of Drugs.
(2) On surrender of the recognition, the essential narcotic drugs as may be in the possession of the recognised medical institution shall be disposed of in such manner, including transfer to another recognised medical institution, as may be specified by the Controller of Drugs.
52-T. Estimates of requirement. (1) Every recognised medical institution shall submit an estimate of its annual requirement of essential narcotic drugs in Form No. 3-J by the 30th November of the preceding calendar year to the Controller of Drugs.
(2) If the requirement of a recognised medical institution exceeds the annual estimate submitted to the Controller of Drugs, it shall submit a revised estimate by the 31st August of the calendar year to which the said annual estimate pertains, to the Controller of Drugs.
Explanation. For the removal of doubts it is hereby clarified that a recognised medical institution may sell and disburse essential narcotic drugs over and above the quantity indicated in the estimate submitted to the Controller of Drugs as specified in this rule, but the designated medical practitioner or the over-all in charge, as the case may be, shall record a brief justification for such increase while filing return in Form No. 3-I.
52-U. Possession of essential narcotic drug by recognised medical institution. A recognised medical institution shall possess essential narcotic drugs in quantities not exceeding the quantities mentioned in the estimate or revised estimate, as the case may be, of the annual requirement of such drug submitted to the Controller of Drugs under Rule 52-T.
52-V. Miscellaneous. (1) The expired stock of essential narcotic drugs shall be destroyed by the recognised medical institution in the presence of an officer nominated by the Controller of Drugs.
(2) The unused essential narcotic drugs returned by the patients shall be considered as receipts by the recognised medical institution.
(3) Essential narcotic drugs shall not be transferred, loaned or sold by the recognised medical institution to other institutions without the prior approval of the Controller of Drugs.
52-W. Home care treatment. (1) Notwithstanding anything contained in these rules, where home care treatment is provided to a patient registered with a recognised medical institution by deputing qualified personnel of such recognised medical institution to the home or residence or place of stay, either permanent or temporary, of such patient, the designated medical practitioner or the over-all in charge, as the case may be, shall, authorise such personnel to carry such quantity of essential narcotic drugs as may be required for treatment of such patient:
Provided that home care treatment shall not be provided for treatment of opioid dependence.
(2) The designated medical practitioner or the over-all in charge shall maintain proper record of such issue and also of the unused essential narcotic drugs received from such personnel after completion of visit to the patient.
52-X. Maintenance of records. All records generated under this Chapter shall be kept for a period of two years from the date of last entry.
52-Y. Inspection of stocks. The stocks of essential narcotic drugs under the custody of a recognised medical institution shall be open for inspection by the Controller of Drugs or any other officer authorised by him in this regard.
52-Z. Appeal. (1) A recognised medical institution aggrieved by any decision or order passed by the Controller of Drugs under this Chapter may appeal to the Secretary to the State Government responsible for implementation of Drugs and Cosmetics Rules, 1945 within a period of sixty days from the date of communication to him of such decision or order.
(2) Every memorandum of appeal shall be accompanied by a copy of the decision or order appealed against.
52-ZA. Procedure for appeal. (1) The Appellate Authority referred to in sub-rule (1) of Rule 52-Z shall give an opportunity to the appellant to be heard in person, if he so desires.
(2) The Appellate Authority referred to in sub-rule (1) of Rule 52-Z may, at the hearing of an appeal allow the appellant to raise any other ground not specified in the appeal, if the Appellate Authority is satisfied that omission of that ground from the appeal was not wilful or unreasonable.
(3) The Appellate Authority referred to in sub-rule (1) of Rule 52-Z may, after making such further inquiry as may be necessary, pass such order as it thinks fit, confirming, modifying or annulling the decision or order appealed against.
(4) The order of the Appellate Authority disposing of the appeal under this rule shall be in writing and shall state the points for determination, the decision thereon and the reasons for the decision.]
Chapter VI
IMPORT, EXPORT AND TRANSHIPMENT OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES