(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 Cosmetic 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.
52ZA. Procedure for appeal.-(!) The Appellate Authority referred to in sub-rule (1) of rule 52Z 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 52Z 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 willful or unreasonable.
Rule 54] The Narcotic Drugs and Psychotropic Substances Rules, 1985 85
(3) The Appellate Authority referred to in sub-rule (1) of rule 52Z 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. I
CHAPTER VI IMPORT, EXPORT AND TRANSHIPMENT OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES 1[53. General prohibition.-Import into and export out of India of the narcotic drugs and psychotropic substances is prohibited except with an import certificate or export authorization issued under the provision of this Chapter:
Provided that import into India or export out of India of the narcotic drugs and psychotropic substances specified in Schedule I of these rules shall be for the purpose mentioned in Chapter VIIA.]
21 .. ·1
54. Import of opium, etc.-The import of-
(i) opium, concentrate of poppy straw, and
(ii) morphine, codeine, thebaine, and their salts is prohibited save by the Government Opium Factory:
3[Provided that nothing in this rule shall apply to import of morphine, codeine, thebaine and their salts by manufacturers notified by the Government, !. Subs. by G.S.R. 224(E), dated 25th March, 2015, for rule 53 (w.e.f. 25-3-2015). Earlier rule 53 was amended by G.S.R. 350(E), dated 25th June, 1997 (w.e.f. 27-6-1997). Rule 53, before substitution, stood as under:
"53. General prohibition.-Subject to the other provisions of this Chapter, the import into and export out of India of the narcotic drugs and psychotropic substances specified. in Schedule I is prolubited:
Provided that nothing in this rule shall apply in case the drug substance is imported into or exported out of India subject to an import certificate or export authorisation issued under the provision of this Chapter and for the purpose mentioned in Chapter VIIA."
2. Rule 53A omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015). Earlier rule 53A was inserted by S.O. 599(E), dated 10th August 1993 (w.e.f. 10-8-1993) and amended by G.S.R. 5S6(E), dated 14th July, 1995 (w.e.f. 20-7-1995). Rule 53A, before omission, stood as under:
"53A. (1) Subject to the provisions of sub-rule (2), no person shall export any of the narcotic drug or psychotropic substance or preparation containing any of such narcotic drug or psychotropic substance specified in [Schedule II] to the countries or to the region of such cowttry specified therein.
(2) Notwithstanding anything contained in sub-rule (1) above, the Narcotics Commissioner may authorise export of specified quantities of such narcotic drug or psychotropic substance or preparation containing such narcotic drug or psychotropic substance on the basis of special import licence issued by the Competent Authority of the country mentioned. in Schedule II which intends such import by way of issuance of special import licence. The shipment of the consignment so allowed shall be accompanied by a copy of such special import licence duly endorsed by the Narcotics Commissioner.''
3. Ins. by S.O. 166!(E), dated 13th July, 2010 (w.e.f. 13-7-2010).
86 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 54 for use in manufacture of products to be exported or to imports of small quantities of morphine, codeine and thebaine and their salts not exceeding a total of 1 kilogram 1[during a calendar year for analytical purposes by an importer], after following the procedure under rule 55 and subject to such conditions as may be specified in the import certificate issued in Form No. 4A.]
55. Application for import certificate.-2[(1) Subject to rule 53, no narcotic drug, or psychotropic substance 3[•»] shall be imported into Indi2 without an import certificate in respect of the consignment issued by the issuing authority, in Form No. 4 4[or Form No. 4A, as the case may be) appended to these rules.]
(2) The importer applying for an import certificate under sub-rule (1) in relation to narcotic drug shall submit along with his application the original or certified copy of the excise permit issued by the concerned State Government.
5[(3) Every application for an import certificate shall be in such form and manner and provide such details as may be specified by the Narcotic Commissioner.]
6[(4) A fee of rupees one thousand shall be paid to the Central Government alongwith the application under sub-rule (1) for issue of each import certificate under this rule.]
56. Issue of import certificate.-7[(1) The Narcotics Commissioner shall issue or deny the import certificate referred to in sub-rule (1) of rule 55 within a period of twenty one working days from the date of receipt of an application completed in all respects and in case the import certificate is not issued within the stipulated time period or denied, the Narcotics Commissioner or any other officer authorised by him in this regard shall inform the applicant the reasons thereof.]
8[(1A)] The issuing authority shall prepare seven copies of the import certificate 9[»•] and deal with them in the manner hereunder provided, namely:-
1. Subs. by G.S.R. 470(£), dated 21st June, 2011, for "during a financial year for analytical purposes by any importer notified by the Government" (w.e.f. 21-6-2011).
2. Subs. by G.S.R. 556(E), dated 14th July, 1995 (w.e.f. 20-7-1995).
3. The words "specified in the Schedule of the Act" omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
4. lns. by 5.0. l66l(E), dated 13th July, 2010 (w.e.f. 13-7-2010).
5. Subs. by G.S.R. 224(E), dated 25th March, 2015, for sub-rule (3) (w.e.f. 25-3-2015). Sub-rule (3), before substitution stood as under:
"(3) The application for the import certificate shall state such details as may be specified by the Narcotics Commissioner."
6. Subs. by G.S.R. 224(E), dated 25th March, 2015, for sub-rule (4) (w.e.f. 25-3-2015). Earlier sub rule (4) was inserted by S.O. 166i(E), dated 13th July, 2010 (w .. e.f. 13-7-2010). Sub-mle (4), before substitution stood as under:
"(4) No import certificate shall be issued unless a fee of rupees one thousand has been paid."
7. Ins. by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
8. Sub-rule (1) re-numbered as sub-rule (lA) therof by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
9. The words "referred to in sub-rule (1) of rule 55" omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
Rule 56] The Narcotic Drugs and Psychotropic Substances Rules, 1985 87
(a) (i) original and duplicate copies should be supplied to the importer who should transmit the original copy to the exporting country and shall produce the duplicate copy at the Customs House, Land Customs Station or Airport where the consignment arrives or, in the case of imports by parcel post, at the post office of delivery, in order to obtain delivery of the consignment of narcotic drugs or psychotropic substances;
(ii) the '[Commissioner of Customs] or Post Master shall state on the copy presented by the importer that the narcotic drugs or the psychotropic substances have actually been imported and return the document to the importer who shall indicate on it that he has received the goods;
(iii) the importer shall return the duplicate copy of the import certificate incorporating the endorsement from the '[Commissioner of Customs] or Post Master and his own endorsement to the issuing authority-(1) where the import certificate relates to narcotic drug, through the excise authorities of the State from which excise permit for purposes of sub-rule (2) of rule 55 was produced; (2) where the import certificate relates to psychotropic substance, through the Drugs Controller of the concerned State;
(b) triplicate copy should be supplied to the '[Commissioner of Customs] concerned who shall return it to the issuing authority along with the copy of the export authorisation to be received at the time of receipt of the consignment from the Government of the exporting country, with an endorsement as to actual quantity of narcotic drugs or psychotropic substances cleared;
(c) quadruplicate copy of the import certificate in relation to narcotic drug should be supplied to the excise authorities of the State into which the narcotic drug is to be imported, and the said copy of the certificate in relation to psychotropic substance should be supplied to the Drugs Controller of the concerned State for comparison with the copy produced before them, by the importer under sub-clause (a) of this sub-rule.
(d) qunituplicate copy should be supplied to the Government of the exporting country for comparison with the copy furnished to them by importer under sub-clause (a) or this sub-rule;
(e) sextuplicate copy should be retained to the Drugs Controller, Government of India;
(f) septuplicate copy should be retained by the issuing authority in his office.
(2) An import certificate issued under sub-rule (1) of rule 55 may allow the importation of the quantity of the concerned drug or the substance in more than one consigrunent.
I. Subs. by G.S.R. 224(E), dated 25th March, 2015, for '"Collector of Customs" (w.e.f. 25-3-2015).
88 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 57
57. Transit.-Subject to the provisions of section 79 of the Act and rule 53, no consignment of any narcotic drug, or psychotropic substances 1[•••] shall be allowed to be transited through India unless such consignment is accompanied by a valid export authorisation in this behalf, issued by the Government of the exporting country:
Provided that the provisions of this rule shall not apply to the carriage by any ship or aircraft, of small quantities of such narcotic drugs and psychotropic substances which are essential for treatment of, or medical aid to, any person on board the ship or aircraft.
58. Application for export authorisation.-2[(1) No narcotic drug or psychotropic substance shall be exported out of India without an export authorization issued by the issuing authority in respect of the consignment, in Form No. 5 appended to these rules.)
(2) The exporter applying for an export authorisation under sub-rule (1) shall submit,-
(a) where the export authorisation relates to narcotic drug, along with his application the original or an authenticated copy of the excise permit issued by the concerned State Government; and
(b) the import certificate in original, issued by the Government of the importing country certifying the official approval of the concerned Government.
3((3) Every application for an export authorization shall be in such form and manner and provide such details as may be specified by the Narcotic Commissioner.)
31(4) A fee of rupees one thousand shall be paid to the Central Government along with the application under sub-rule (1) for issue of each export authorization under this rule.)
59. Issue of export authorisation.-41(1) The Narcotics Commissioner shall issue or deny the export authorization referred to in sub-rule (1) of rule 58 within I. The words "specified in Schedule of the Act" omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015). Earlier these words were amended by G.S.R. 556(E), dated 14th July, 1995 (w.e.f. 20-7-1995).
2. Subs. by G.S.R. 224(E), dated 25th March, 2015, for sub-rule (11 (w.e.f. 25-3-2015). Earlier sub rule (!), was substituted by G.S.R. 556(E), dated 14th July, 1995 (w.e.f. 20-7-1995). Sub-rule(!), before substitution by G.S.R. 224(E), dated 25th March, 2015 stood as under:
"(1) Subject to rules 53 and 53A, no narcotic drugs, or psycbotropic substances specified in the Schedule of the Act, shall be exported out of India without an export authorisation in respect of the consignment issued by the issuing authority in Form No. 5 appended to these rules."
3. Subs. by G.S.R. 224(E), dated 25th March, 2015, for sub-rule (3) and (4) (w.e.f. 25-3-2015).
Earlier Sub-rule (3) was omitted and sub-rule (4) renumbered as sub-rule (3) thereof by S.O.
556(E), dated 14th July, 1995 (w.e.f. 20-7-1995) and sub-rule (4) was inserted by S.O. 1661(E), dated 13th July, 2010 (w.e.f. 13-7-2010). Sub-rule (3) and (4), before substitution by G.S.R.
224(E), dated 25th March, 2015 stood as under.
"(3) The application foe the export authorisation shall state such details as may be specified by the Narcotics Commissioner.
(4) No export authorisation shall be issued Wlless a fee of rupees one thousand has been paid."
4. Ins. by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
Rule 62] The Narcotic Drugs and Psychotropic Substances Rules, 1985 89 a period of twenty one working days from the date of receipt of an application completed in all respects and in case the export authorization is not issued within the stipulated time period or denied, the Narcotics Commissioner or any other officer authorised by him in this regard shall inform the applicant the reasons thereof. I 1[(1A)) The issuing authority shall prepare five copies of the export authorisation 2[• .. ] and deal with them in the manner hereunder provided, namely:-
(a) the original should be supplied to the consignor which shall accompany the consignment;
(b) the duplicate copy should be forwarded to the 3[Commissioner of Customs] of the port who will return it to the issuing authority indicating on it the date of export and the quantity exported;
(c) the triplicate copy should be forwarded to the Government of the importing country;
(d) the quadruplicate copy should be forwarded to the excise authority of the State in which the exporter has his place of business;
(e) quintuplicate copy should be retained by the issuing authority in his office;
(2) Where the consignment of narcotic drug or psychotropic substance is to be transhipped or transited through one or more countries, such additional number of copies of export authorisation as may be required shall be prepared and sent to the concerned country or, as the case may be, countries.
60. Transhipment.-Subject to the provisions of section 79 of the Act and rule 53, no consignment of narcotic drug, or psychotropic substance 4 [ .. •] shall be allowed to be transhipped at any port in India save with the permission of the 5[Commissioner of Customs].
61. Procedure for transhipmenL-The 5[Commissioner of Customs] while allowing any consignment of narcotic drug, or psychotropic substances, 4[ .. •] to be transhipped shall, inter alia, satisfy himself that the consignment is accompanied by a valid export authorisation issued by the exporting country.
62. Diversion of consignment.-(1) The 5[Commissioner of Customs] shall take all due measures to prevent the diversion of such consignment to a destination other than that named in the aforesaid export authorisation.
(2)(a) The 5[Commissioner of Customs] may permit diversion of such a consignment to a country other than that named in the accompanying copy of I. Subs-rule (!) re-numbered as sub-rule (IA) thereof, by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
2. The words "referred to in sub-rule (1) of rule 58" omitted by G.S.R. 224{E), dated 25th March, 2015 (w.e.f. 25-3-2015).
3. Subs. by G.S.R. 224(E), dated 25th March, 2015, for "Collector of Customs" (w .e.f. 25-3-2015).
4. The words "specified in Schedule of the Act" omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015). Earlier these words were amended by G.S.R. 556(E), dated 14th July, 1995 (w.e.f. 20-7-1995).
5. Subs. by G.S.R. 224(E), dated 25th March, 2015, for "Collector of Customs" (w.e.f. 25-3-2015).
90 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 62 the export authorisation subject to the production of export authorisation issued by the issuing authority as provided under rule 58, as if the diversion were an export from India to the country, or territory of new destination.
(b) The 1[Commissioner of Customs] shall inform the issuing authority regarding the actual quantity of the narcotic drug or psychotropic substance, the diversion of the consignment of which was allowed under clause (a), whereupon the issuing authority shall, inform the country from which the export of the consignment originated.
63. Prohibition of import and export of consignments through a post office box, etc.-The import or export of consignments of any narcotic drug or psychotropic substance through a post office box or through a bank is prohibited.
CHAPTER VII PSYCHOTROPIC SUBSTANCES 2[64. Manufacture of psychotropic substances.-(1) No person shall manufacture any of the psychotropic substances except in accordance with the conditions of a licence granted under the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the 1945 rules) framed under the Drugs and Cosmetics Act, 1940 (23 of 1940), by an authority in-charge of Drugs Control in a State appointed by the State Government in this behalf:
Provided that a licence to manufacture a psychotropic substance specified in Schedule I shall be issued only for the purposes mentioned in Chapter VIIA:
Provided further that the authority in charge of the drug control in a State shall consult the Narcotics Commissioner before issuing a licence to manufacture a psychotropic substance specified in Schedule I.
(2) The authority in charge of drugs control in a State (hereinafter referred to as the Licensing Authority) shall consult the Narcotics Commissioner with regard to the assessed annual requirements of each of the psychotropic substances in bulk form referred to in sub- rule (!) in the country and taking into account the requirement of such psychotropic substances in the State, the quantity of such substance required for supply to other manufacturers outside the State and the quantity of such substance required for reasonable inventory to be held by a manufacturer, shall specify, by order, the limit of the quantity of such substance which may be manufactured by the manufacturer in the State.
(3) The quantity of the said psychotropic substance which may be manufactured by a licensee in a year shall be intimated by the Licencing Authority to the licensee at the time of issuing the licence.]
1. Subs. by G.S.R. 224(£), dated 25th March, 2015, for "Collector of Customs" (w.e.f. 25-3-2015).
2. Subs. by G.S.R. 224(£), dated 23rd March, 2015, for rule 64 (w.e.f. 23-3-2015). Rule 64, before suhbstitution, stood as under:
"64. General prohibition.-No person shall manufacture, possess, transport, import inter State, export inter-State, sell, purchase, conswne or use any of the psychotropic substances specified in Schedule I."
Rule 65) The Narcotic Drugs and Psychotropic Substances Rules, 1985 91 1(65. Registration and submission of retums.-(1) A person who has been issued licence to manufacture one or more psychotropic substances shall register with the Narcotics Commissioner for each of the substances in the form and manner as may be specified by the Narcotics Commissioner:
Provided that the requirement of registration under this sub-rule shall be complied within a period of one hundred and eighty days from the date of coming into force of these rules.
(2) A person who has registered with the Narcotics Commissioner under sub-rule (1) shall file quarterly return with the Narcotics Commissioner in such form and manner as may be specified by the Narcotics Commissioner.
(3) The return for a quarter shall be filed before the last day of the month following that quarter.
(4) If the return for a quarter is not filed before the due date by a person registered under sub-rule (1), the Narcotics Commissioner may issue notice to explain the reasons therefor and after considering the reasons submitted, if any, may pass orders for revoking the registration.
(5) The registration under sub-rule (1) shall be deemed to be revoked, if the quarterly return for three successive quarters is not filed.
1. Subs. by G.S.R. 224(E), dated 25th March, 2015, for rule 65 (w.e.f. 25-3-'.!015}. Earlier rule 65 was amended by G.S.R. 350(E), 25th June, 1997 (w.e.f. 27-6-1997) and by G.S.R. 214(E), dated 19th March, 2002 (w.e.f. 19-3-2002}. Rule 65, before substitution, stood as nnder:
"65. Manufacture of psychotropic substances.-(1) Subject to the provisions of sub-rule (2), the manufacture of any of the psychotropic substances other than those specified in Schedule I shall be in accordance with the conditions of a licence granted under the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the 1945 Rules) framed under the Drugs and Cosmetics Act, 1940 (23 of 1940), by an authority in charge of Drugs Control in a State appointed by the State Government in this behalf:
Provided that the authority in charge of drug control in a State referred to above may issue a licence to manufacture a psychotropic substance specified in Schedule III for the purpose of export only;
(2) The authority in charge of drugs control in a State (hereinafter referred to as the Licensing Authority) shall mnsult the Drugs Controller (India) in regard to the assessed annual requirements of each of the psychotropic substances in bulk form referred to in suh rule (1) in the country and taking into account the requirement of such psychotropic substances in the State, the quantity of such substance required for supply to other manufacturers outside the State and the quantity of such substance required for reasonable inventory to be held by a manufacturer, shall specify, by order, the limit of the quantity of such substance whkh may be manufactured by the manufactwer in the State.
(3) The quantity of the said psychotropic substance which may be manufactured by a licensee in an year shall be inti.mated by the Licencing Authority to the licensee at the time of i~suing the licence:
Provided that nothing contained in this rule shall apply in case the psychotropic substances specified in Schedule I are manufactured, possessed, transported, imported inter-State, exported inter-State, sold, purchased, consumed or used subject to other provisions of this Chapter which applies to psychotropic substances which are not included in Schedule I and for the purposes mentioned in Chapter VIIA:
Provided further that the authority in charge of the drug control in a State referred to in sub-rule (2) of rule 65 shall consult the Narcotics Commi'IBioner before issuing a licence under rule 65 in respect of psychotropic substances included in Schedule I and Schedule III.".
92 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 65
(6) An appeal against an order passed under sub-rule (4) may be made to the Secretary, Government of India, Ministry of Finance, Department of Revenue or any other officer, not below the rank of Additional Secretary to the Government of India, authorized by him in this behalf, within thirty days from the date of communication of such order.
(7) Every memorandum of appeal shall be accompanied by a copy of the order appealed against.
(8) The Appellate Authority shall, after making such further inquiry as may be considered necessary, pass such orders as it thinks fit, confirming, modifying or annulling the order appealed against.
Explanatinn.-For the purposes of this rule, the expression "quarter" shall be January to March, April to June, July to September and October to December of every year. I 1[65A. Sale, purchase, consumption or use of psychotropic substances.-No person shall sell, purchase, consume or use any psychotropic substance except in accordance with the Drugs and Cosmetics Rules, 1945:]
2[Provided that sale, purchase, consumption or use of a psychotropic substance specified in Schedule I shall be only for the purposes mentioned in Chapter VIIA.]
66. Possession, etc., of psychotropic substances.-3[(1) No person shall possess any psychotropic substance for any of the purposes covered under 1945 rules, unless he is lawfully authorized to possess such substance for any of the said purpoSP.s under these rules:
Provided that possession of a psychotropic substance specified in Schedule I shall be only for the purposes mentioned in chapter VIIA.]
(2) Notwithstanding anything contained in sub-rule (1), any research institution or a hospital or dispensary maintained or supported by Government or local body or by charity or voluntary subscription, which is not authorised to possess any psychotropic substance under the 1945 Rules, or any person who is not so authorised under the 1945 Rules, may possess a reasonable quantity of such substance as ma.y be necessary for their genuine scientific requirements or genuine medical requirements, or both for such period as is deemed necessary by the said research institution or, as the case may be, the said hospital or dispensary or person:
Provided that where such psychotropic substance is in possession of an individual for his personal medical use the quantity thereof shall not exceed one hundred dosage units at a time:
I. Ins. by 5.0. 1661(E), dated 13th July, 2010 (w.e.f. 13-7-2010).
2. Ins. by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015).
3. Subs. by G.S.R. 224(E), dated 25th Mnch, 2015, for sub-rule (1) (w.e.f. 25-3-2015). Sub-rule (1), before substitution, stood as under:
"(1) No person shall possess any psychotropic substance for any of the purposes covered by the 1945 Rules, unless he is lawfully authorised to possess such substance for any of the said purposes under these rules."
Rule 67] The Narcotic Drugs and Psychotropic Substances Ru/es, 1985 93 '[Provided further that an individual may possess the quantity of exceeding one hundred dosage units at a time 2[but not exceeding three hundred dosage units at a time) for his personal long term medical use if specifically prescribed by a Registered Medical Practitioner.]
(3) The research institution, hospital and dispensary referred to in sub-rule
(2) shall maintain proper accounts and records in relation to the purchase and consumption of the psychotropic substance in their possession.
67. Transport of psychotropic substance.-3[(1) No consignment of psychotropic substance shall be transported, imported inter-State or exported inter-State unless such consignment is accompanied by a consignment note in Form 6 appended to these rules and in the manner as provided hereinafter:
Provided that a psychotropic substance specified in Schedule I shall be transported, imported inter-State or exported inter-State only for the purposes mentioned in Chapter VIIA:
Provided further that a psychotropic substance specified in Schedule I shall be transported for export out of India only after an export authorization is issued by the Narcotics Commissioner under rule 59.)
(2) The consignment note referred 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 psychotropic substances 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.
4[• .. 1
(4) The consignor and consignee shall keep such consignment note for a period of two years and the said note may be inspected at any time by an officer authorised in this behalf by the Central Government.
5[Provided that consignment note in Form 6 shall not apply in cases where the sale of the psychotropics substance 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:- !. Ins. by G.S.R. 639(E), dated 13th October, 2006 (w.e.f. 13-10-2006).
2. Ins by G.S.R. 2(E), dated 1st January, 2008 (w.e.f. 1-1-2008).
3. Subs. by G.S.R. 224(E), dated 25th March, 2015, for sub-rule (I) (w.e.f. 25-3-2015). Earlier sub rule (!), was amended by G.S.R. 104(E), dated 25th February, 2005 (w.e.f. 25-2-2005). Sub rule (1), before substutution stood as under:
"(l) Subject to the provisions of rule 64, no consignment of psychotropic substance shall be transported, imported inter-State or exported inter-State unless such consignment is accompanied by a consignment note in [Form 6] appended to these Rules and in the manner as provided hereinafter."
4. Sub-rule (3) omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015). Sub-rule (3), before omission, stood as under:
"(3) The consignor shall make necessary entries on the triplicate copy of the said note with reference to the receipt of quantity of the psychotropic substances indicated on that duplicate copy of the note."
5. Ins. by G.S.R. 104(E), dated 25th February, 2005 (w.e.f. 25-2-2005).
94 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 67
(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 document shall be preserved by consignor and consignee for a period of two years for inspection by the officers referred to in sub-rule (4) above.
Explanation.-Where the consignee is a research institution, registered medical practitioner, hospital or dispensary, the requirement of incorporating licence number of consignee shall not be applicable.]
1[CHAPTER VIIA SPECIAL PROVISIONS REGARDING MANUFACTURE, POSSESSION, TRANSPORT, IMPORT-EXPORT, PURCHASE AND CONSUMPTION OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES FOR '[MEDICAL, SCIENTIFIC AND TRAINING PURPOSES] 67 A. Notwithstanding anything contained in the foregoing provisions of these rules- ( a) a narcotic drug and psychotropic substance may be used for-
(i) scientific requirement including analytical requirements of any Government laboratory or any research institution in India or abroad;
(ii) very limited medical requirements of a foreigner by a duly authorised person of a hospital or any other establishment of the Government especially approved by that Government;
(iii) the purpose of de-addiction of drug addicts by Government or local body or by an approved charity or voluntary organisation or by such other institution as may be approved by the Central Government.
3[or the authority exercising the powers under sub-clause (iv) of clause (a)] 3[(iv) the purpose of restraining or immobilising wild animals by or under the authority of the Government and approved by that Government.]
(b) persons performing medical or scientific functions 3[or the authority exercising the powers under sub-clause (iv) of clause (a)] shall keep records concerning the acquisition of the substance and the details of
1. ChaptPr VIIA (containing sPction 67A) ins. by G.S.R. 350(E), dated 25th Junt), 1997 (w.c.f.
27-o-1997)
2. Subs. by G.S.R. 639(E), dated 13th Octobec, 2006. for "MEDICAL AND SCIENTIFIC PURPOSES" (w.e.t. 13-10-2006).
3. Ins. by G.S.R. 90S(E), dated 28th December, 2011 (w.e.f. 28-12-2011).
Rule 670] The Narcotic Drugs and Psychotropic Substances Rules, 1985 95 their use in Form 7 of these rules and such records are to be preserved for at least two years after their (sic);
(c) a narcotic drug and psychotropic substance may be supplied or dispensed for use to a foreigner pursuant to medical prescription only from the authorised licensed pharmacists or other authorised retail distributors designated by authorities responsible for public health.]
1[67B. (1) Notwithstanding anything contained in these rules, the government Opium and Alkaloid works may procure, manufacture or import and supply narcotic drugs and psychotropic substances as may be required as samples by various drug law enforcement agencies, testing laboratories and training institutions of the Central and State Governments.
(2) The Government Opium and Alkaloid Works may also supply samples to organisations other than those covered by sub-rule (1) with the prior approval of the Central Government.
(3) Any enforcement agency, laboratory, training institution or organisation requiring the samples shall apply to the Chief Controller of Factories in Form No. 8.
(4) The quantities of various narcotic drugs and psychotropic substances to he supplied as samples shall be determined by the Central Government from time to time. The organisation obtaining the samples shall designate an officer, at the time of sending the request for samples, in whose custody the samples shall be kept.
(5) The organisation requisitioning the samples shall maintain records and submit an annual report to the Chief Controller of Factories in Form No. 9.
(6) When a sample is used for training, the organisation shall maintain a record of the quantity of drug taken out for training and the quantities actually used.]
1[67C. Notwithstanding anything contained in these rules, the Narcotics Commissioner may permit import or export of narcotic drugs and psychotropic substances for the purpose of controlled deliveries, investigations, intelligence collection scientific analysis.]
2[CHAPTER VIIB REPORTS, RETURNS AND ESTIMATES UNDER INTERNATIONAL CONVENTIONS
670. Submission of reports and returns under international conventions.
(1) All reports and returns which are required to be submitted under any international convention, shall be submitted to an international agency by such officer the Central Government may, by notification in the Official Gazette, appoint in this behalf from time-to-time.
I. Ins. by G.S.R. 639(E), dated 13th October, 2006 (w.e.f. 13-10-2006).
2. Chapter VIIB (containing sections 670 and 67E) ins. by S.O. 1661(E), dated 13th July, 2010 (w.e.f. 13-7-2010).
96 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 67D
(2) The officer appointed under sub-rule (1) may call for such inputs as may be necessary to submit the returns under sub-rule (1), from the Narcotics Commissioner, the Chief Controller of Factories or any other officer of the Central Government or any State Government indicating the format in which the information is required and the time by which it is required.
(3) The officer from whom inputs have been called for under sub-rule (2), shall provide all inputs which are sought and which are available with him in the format in which it has been called for and within the time indicated in sub rule (2) and shall also indicate the information not maintained by him or not available.
67E. Estimates and quotas.-(1) If, estimates of requirement of any narcotic drug have to be submitted under any international convention, resolution or commitment, the same shall be submitted to an international agency by such officer the Central Government may, by notification in the Official Gazette, appoint in this behalf from time-to-time.
(2) The estimates for use and consumption of narcotic drugs approved by international agencies for India shall be allotted as quotas to users within the country by such officer as may be notified by the Central Government by notification in the Official Gazette from time-to-time.
(3) The users to whom such quota is allotted shall not exceed the quota allotted to him and shall submit to the officer appointed under sub-rule (2), such statistics of consumption and use of the narcotic drugs and within such time as may be indicated by the officer.]
CHAPTER VIII MISCELLANEOUS
68. Repeal and savings.-(1) The Central Opium Rules, 1934, the Dangerous Drugs (Import, Export and Transhipment) Rules, 1957, and the Central Manufactured Drugs Rules, 1962 are hereby repealed.
(2) Notwithstanding such repeal, anything done or any action taken or purported to have been done or taken under any of the rules repealed by sub rule (1) shall, in so far as it is not inconsistent with the provisions of these rules, be deemed to have been done or taken under the corresponding provisions of these rules.
I. Narcotic drugs
1. Coca Leaf
2. Cannabis (Hemp)
3. (a) Acetorphine 1[SCHEDULE I (See rules 53 and 64)
(b) Diacetylmorphine (Heroin)
(c) Dihydrodesoxymorphine (Desmorphine)
1. Subs. by G.S.R. 639(E), dated 13th October, 2006, for Schedule I (w.e.f. 13-10-2006).
Sch. Ill] The Narcotic Drugs and Psychotropic Substances Rules, 1985 97
(d) Etorphine
(e) Ketobemidone els d ther substances containing any of . d ·xtures extra an ° and their salt.:;, preparations, a m1 , these drugs.
II. Psychotropic substances SI. International non-proprietary No. names (I) (2) I. Etryptamine
2. Methaqualone
3.
'[4. Mephedrone
5. Salts and preparations of above} Other nonproprietary names
(3) Methcathinone 4-methylmethcathinone (4-MMC) 4-methylephedrone '[*'•] 3[11-11-•J Chemical names
(4) J-(2-aminobutyl) indole 2-methyl-3-o-tolyl-4(3H)-quinazolinone 2-(methylamino)-1 phenylpropan-1-one (RS)-2-methylamino-1- (4-methylphenyl) propan-1-one
1. Subs. by G.S.R. 74(E), dated 5th February, 2015, for item 4 and entries relating thereto.
2. Schedule II omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015). Eulier Schedule II was substituted by G.S.R. 639(E), dated 13th October, 2006 (w.e.f. 13-10-2006).
Earlier to that Schedule II was omitted by G.S.R. 559(E), dated 10th August, 1993 (w.e.f.
10-8-1993) and Schedule IV which was inserted by G.S.R. 559(E), dated 10th August, 1993 (w.e.f. 10-8-1993) was renumbered as Schedule II by G.S.R. 556(E), dated 14th July, 1995 (w.e.f. 20-7-1995).
3. Schedule llI omitted by G.S.R. 224(E), dated 25th March, 2015 (w.e.f. 25-3-2015). Earlier Schedule III was substituted by G.S.R. 639(E), dated 13th October, 2006, (w.e.f. 13-10-2006).
Earlier to that Schedule III was omitted by G.S.R. 559(E), dated 10th August, 1993 (w.e.f. 10- 8-1993) and was inserted by G.S.R. 214(E), dated 19th March, 2002 (w.e.f. 19-3-2002).
FORM NO. 1 (See rule 7) GOVERNMENT OF INDIA CENTRAL BUREAU OF NARCOTICS LICENCE TO GROW OPIUM POPPY FOR PRODUCTION OF OPIUM OR POPPY STRAW Name and Parentage of Village the licensee Pargana/District Tehsil Licence Number Clase, of opium as assigned by D.O.O.
1 Hectares Area measured Area test-measured Area harvested (Entries to be made at the time of weighments) Weight of opium (Kg.)
2 Assumed weight at 70"C(Kg.)
3 Price payable on the basis of assumed weight 70<>C 4 Amount withheld pending final examination of opium at factory 5 Area Amount paid at weiglunents 6 Area Licensed Signature (S.1.)
(lnspector/D.0.0.)
(5.1.)
Plot No.(s} as per revenue records Signature and Seal District Opium Officer (Entries to be made at the time of final payment.
Total Average Total Amount Amount weight of yield of amount already paid/ opium at the payable paid at received 70°C on cultiva- on the the time at the the basis of tor basis of of weigh- time of factory's factory ments final report report payments 7 8 9 10 11 <O 0, ti' 3 Signature and Seal _..
District Opium Officer Form 2] The Narcotic Drugs and Psychotropic Substances Rules, 1985 98A ' ..
2.
3.
4.
5.
6.
FORM NO. 2 (See rule 8) APPLICATION FOR GRANT OF LICENCE FOR OPIUM POPPY CULTIVATION FOR PRODUCTION OF OPIUM OF POPPY STRAW Crop year ....................... ..
Name of the Cultivalor ...................................................................................................... .
Father's Name· ..................................................................................................................... .
Village .............................................. Tehsil.. .............................. District. ............................. .
Khasra No. of the plot of land in which poppy is to be cultivated .......................... .
Whether the plot is in the name of the applicant as per revenue records. If not1 in whose name? ........................................................................................................................ .
Whether the plot specified in column 4 has irrigation facilities (kind of irrigation facilities available, i.e., well, tubewell, etc., .................................................................. ..
7. Area required for opium poppy cultivation .................................................................. .
8. Whether the applicant cultivated the poppy in ......................................................... ..
the past, if so, the latest year in which he .................................................................. .
cultivated poppy.
9. Whether the applicant was ever proscribed from poppy cultivation or was de-licensed for tendering adulterated opium, excess cultivation, violations of Departmental instructions. If so, the year and the reasons for proscription ..................... .
1 hereby certify that the particulars shown above are correct and the land in which opium poppy is to be cultivated is free from litigation.
Attestation (to be made by Lambardar) Signature/Thumb-impression of cultivator (To be completed by the Sub-Inspector lncharge) A. Performance of the cultivator during the preceding crop year.
Crop year ................................................. Area licensed .................................................... ..
Area measured ........................................ Area harvested .................................................. .
Average yield at 70"C ......................................................................................................... .
B. Whether the cultivator has ever been proscribed on account of excess cultivation and violation of Departmental instructions, etc., if so the particulars thereof.
Signature .......................... .
(Sub-Inspector lncharge) The particulars above recorded by the Sub-Inspector have been verified by me. The cultivator is eligible/ineligible for grant of a licence.
Signature(Sub-lnspector lncharge) Area allotted by the District Opium Officer.
Signature of bistrict Opium Officer 98B The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Form 2 Conditions of licence I. The licensee shall not transfer this licence and cultivate pappy only for production of opium or PoPPY straw over the area of land and the plot(s} specified in the licence.
2. The land in which PoPPY will be cultivated by the cultivator shall be free from litigation.
3. The licensee shall get his daily collections of opium obtained from the crop weighed by the Lambardar and affix his signature/thumb-impressions against each entry made by the Lambardar in token of correctness of such entry made by the Lambardar and shall submit to preliminary weighments carried out by the staff of the Narcotics Department in the village during which he shall produce the entire quantity collected by him.
4. The licensee shall bring to, and deliver at the place fixed and notified for weighments all opium collected by him from the crop and shall accept for opium so brought by him the price fixed by the Central Government for that crop year.
5. The licensee shall deliver the opium either himself or through any person authorised by him at the time of its weighment and his opium shall be weighed under the supervision of the District Opium Officer or any other officer authorised in this behalf by the Narcotics Commissioner in accordance with rule 14 of the Narcotic Drugs and Psychotropic Substances Rules, 1985.
6. If the licensee does not surrender his entire produce of opium to Government or retains, embezzles or otherwise illegally dispases of any part of the same he shall be liable to be prosecuted as per the provisions of the Narcotics Drugs and Psychotropic Substances Act, 1985.
7. The licensee shall extract as much opium as is reasonably possible from all implements, pots and cloth used by him in collecting opium and impregnated with opium in consequence of such use.
8. The final payment for opium delivered by the licensee shall be made to him at appropriate time fixed by the District Opium Officer or any other officer authorised in this behalf.
9. If on the final adjustment of accounts any sum is found due from the licensee, he shall pay ii to the District Opium Officer or any other officer authorised in this behalf in the manner specified. If the licensee fails to pay the sum due from him it may be recovered from him in the manner prescribed by section 72 of the Narcotic Drugs and Psychotropic Substances Act, 1985.
10. The licence may be withheld or cancelled at any time if any fact is revealed against the licensee which makes him ineligible for grant of the licence.
11. The licensee shall comply with the provisions of Narcotic Drugs and Psychotropic Substances Act, 1985, the Rules framed thereunder and any order issued by the competent authorities of the Narcotics Department from time to time.
12. The licensee shall be punishable under the relevant provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 for any breach of the conditions of the licence.
FORM NO. 3 '[See rules 36 and 37] LICENCE FOR MANUFACTURE OF MANUFACTURED DRUGS Licence No .............................................. Date of issue .................................................... .
..................................................................... is hereby licensed to manufacture the following manufactured drugs on the premises situated at. ................................................................... .
1. Subs. by G.S.R. 95(E), dated 4th February, 2004, for "(See rule 37)" (w.e.f. 4-2-2004).
Fonn 3A] The Narcotic Drugs and Psychotropic Substances Rules, 1985 98C Name of drug (I)
(2) Quantity
2. The licence shall be in force from ............ to ............. .
3. The licence is subject to the conditions stated below and to such other conditions as may be specified in the rules for the time being in force under the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985).
Signature ........................ .
Date .................. . Designation ..................... .
Conditions of licence
1. This licence is not transferable.
2. This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an officer detailed for the purpose by the Licensing Authority.
3. The licensee shall not manufacture or keep the drug or the materials used for the manufacture of the drug at any other place except his place of business.
4. The licensee shall ens'..lre manufacture of the drug to the standard and specifications laid down by or under the Drugs and Cosmetics Act, 1940 (23 of 1940).
5. The licensee, if he desires the renewal of his licence, shall apply to the Licensing Authority in the form specified for such renewal, at least thirty days before the expiry of his licence.
6. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the 1[the person or the entity] operating under the licence.
Where any change in the constitution of the 1[the person or the entity] takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place or the normal expiry of the licence whichever is earlier unless in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the 1[the person or the entity] with the changed constitution.
'[FORM NO. 3A (See rule 36A) Licence No. ................................... Date of issue ................................... .
M/s ......................... is hereby licensed to manufacture concentrate of poppy straw and the following manufactured drugs on the premises situated at. ..................... ..
Name of the drug Quantity
(i)
(ii)
(iii)
2. The licence shall be in force from ......................................... to .................................... .
The licence is subject to the conditions stated below and to sltch other conditions as may be specified in the rules for the time being in force under the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985).
Date ....................... . Signature ....................... .
Designation ....................... .
1. Subs. by G.S.R. 95(E), dated 4th February, 2004, for "firm" (w.e./. 4-2-2004).
2. Ins. by 5.0. 1661(E), dated 13th July, 2010 (w.e./. 13-7-2010).
980 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Form 3A Conditions of Licence
(a) This licence shall not be transferable;
(b) The licensee shall manufacture concentrate of poppy straw from the poppy straw produced in the fields licensed for the purpose,
(c) This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an officer detailed for the purpose by the Licencing Authority;
(d) The licensee shall ensure that the drugs that he manufactures are as per the specifications laid down by or under the Drugs and Cosmetics Act, 1940;
(e) The licensee shall, if he desires, submit applications for renewal of his licence at least thirty days before the expiry of his licence.
(f) The licensee shall inform the Licencing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place or normal expiry of the licence whichever is earlier unless in the meantime, a fresh licence has been taken from the Licencing Authority in the name of the firm wilt, the changed constitution;
(g) The licensee shall be fully responsible to ensure the security of the factory premises and ensure that no diversion takes place in them;
(h) The licensee should provide security equipment such as surveillance cameras and other facilities as may be specified by the Narcotics Commissioner to ensure security on the fields;
(i) The licensee should report to the Narcotics Commissioner if he finds any farmer lancing or diverting;
G) The licensee shall keep the Central Bureau of Narcotics informed of all matters relating to cultivation, production, transport, etc., of poppy straw and changes in agricultural practices;
(k) The licensee shall defray the cost of the Central Bureau of Narcotics staff posted to supervise the cultivation of opium for production of poppy straw and production of concentrate of poppy straw at such rates as may be decided by the Government from time-to-time;
(I) The licensee shall notify well before the sowing season, the price which they are willing to pay for the pods;
(m) The licensee should identify and enter into agreements with the farmers who are willing to cultivate opium poppy for production of poppy straw for sale to the licencee;
(n) The farmers with whom the licensee has entered into agreements will be licensed to grow opium poppy subject to such verifications as may be felt necessary by the Narcotics Commissioner,
(o) Such other conditions as may be specified by the Narcotics Commissioner from time-to-time.]
Form 3CJ The Narcotic Drugs and Psychotropic Substances Rules, 1985 98E '[FORM NO. 38 [See rule 52A(3)1 SPECIAL AUTHORISATION FOR POSSESSION OF ESSENTIAL NARCOTIC DRUGS BY REGISTERED MEDICAL PRACTITIONER Authorisation No ......... Date of issue ....... .
..................... is hereby authorised to possess the following essential narcotic drugs on the premises situated at ................ for use in his practice.
Name of essential narcotic drug
(1)
(2) Quantity
2. The authorisation shall be in force from ................ to ............... .
3. The authorisation is subject to the conditions stated below and to such other conditions as may be specified under the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and the rules made thereunder.
1.
2.
3.
4.
Signature ............... .
Designation ........... , ... .
Conditions of authorisation
1. This authorisation is not transferable.
2. This authorisation and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an officer detailed for the purpose by the issuing authority.]
'(FORM NO. 3C (See rule 520) CONSIGNMENT NOTE Date and time of dispatch of the consignment: ................................................ .
Name and complete postal address of the consignor Whether Manufacturer or Licenced Dealer (Quote Licence Number and the Issuing Authority) Name and complete postal address of the consignee Description and quantity of the consignment :
:
:
Particuiars of the essential narcotic drugs showing Number Quantity Trade Marks, Proprietary Names, Batch number, etc. of packages Gross Net
5. Mode of transport (particulars of the transporter, Registration :
number of the vehicle or Railway Receipt./Lorry Receipt, if the transport is by railways good transports) Full Name/Designation (if any) Signature of the Consignor with date To be filled by the consignee I. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. 5-5-2015).
98F The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Form 3C
6. Date and time of receipt by the consignee and his remarks :
7. Whether the consignment received in full as per : Yes / No (If 'no', description and quantity mentioned ·at serial number 4 details to be above mentioned below.)
Full Name/Designation (if any) Note:
Signature of the Consignee with date (I) This consignment note shall be serially numbered on annual basis.
(2} The consignor shall record a certificate on the cover page of each book containing consignment note indicating the number of pages contained in the consignment note-book.
(3) The consignor shall maintain a Register showing the details of the books of consignment note brought in use during a particular year.
(4) This consignment note shall be retained for a period of two years from the date of transaction.
(5) The records referred to in this note shall be produced before the concerned authorised officers whenever called upon during the course of their inspection/ investigation.]
'[FORM NO. 30 [See rule 52H(2)] DAILY ACCOUNTS OF ESSENTIAL NARCOTIC DRUGS TO BE MAINTAINED BY REGISTERED MEDICAL PRACTITIONER AND AUTHORISED PERSONS Name of the Essential : ........................ Authorised limit : ························ Narcotic Drug Date : ........................
I. Opening stock
2. Quantity received 2(i) Received from (give details) 2(ii) Consignment Note/Bill/Invoice/Cash Memo, Number etc.
3. Quantity dispensed
4. Name and address of the person to whom dispensed (include patient registration number maintained in Form No. 3E, where applicable)
5. Closing stock Full Name/Designation (if any) Note:
:
:
:
:
:
:
:
Signature (!) This record shall be maintained on day to day basis and entries shall be made for each day.
(2) Entries shall be completed for each day before the dose of the day.
(3) The pages of the register shall be serially numbered.
!. Ins. by G.S.R 359(E), dated 5th May, 2015 (w.e./. 5-5-2015).
Form 3F] The Narcotic Drugs and Psychotropic Substances Rules, 1985
(4) Separate record shall be maintained for each essential narcotic drug.
(5) This record shall be retained for two years from the date of last entry.
98G
(6) This record shall be produced before the concerned authorised officers whenever called upon during the course of their inspection/investigation.]
'[FORM NO. 3E [See rule 52H(3)] DETAILS OF THE PATIENT TO WHOM ESSENTIAL NARCOTIC DRUGS DISPENSED (TO BE MAINTAINED BY REGISTERED MEDICAL PRACTITIONER/ RECOGNISED MEDICAL INSTITUTION) Registration Number Date ]. Name :
2. Complete postal address (with contact number, if any) :
3. Brief description of the illness :
4. VVC1ether registered with any other registered medical :
practitioner/recognised medical institution (If yes, c'etail.' to !:Je recoded)
5. Details of the ~ssential narcotic drugs dispensed :
Date Name of the essential Quantity Signature/Thumb Remarks, if narcotic drugs impression of any the patient Note:
(1) This record shall be retained for two years from the date of last entry.
(2) This record shall be produced before the concerned authorised officers whenever called upon during the course of their inspection/investigation.]
].
2.
3.
'[FORM NO. 3F [See rule 52-0(1)] APPLICATION FOR ISSUE/RENEWAL OF CERTIFICATE OF RECOGNITION AS RECOGNISED MEDICAL INSTITUTION Name and complete postal address of the institution with :
telephone number, facsimile number and e-mail ID (relevant supporting documents to be submitted) Name of the Head/In-charge of the Institution :
Number of persons employed :
(i) Doctors
(ii) Nursing staff
(iii) Others
1. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. 5-5-2015).
98H The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Form 3F
4. Number of patients treated during the previous calendar year :
(i) in patients
(ii) out patients
(iii) home care
5. Name(s) of the qualified medical practitioner(s) who would prescribe essential narcotic drugs (give details of their training in pain relief and palliative care or opioid dependence treatment) :
6. If there is more than one qualified medical practitioner who would prescribe essential narcotic drugs, indicate the name of the medical practitioner who shall be overall in charge :
7. N11mber and date of the certificate of recognition issued earlier (attach copy) :
8. Whether the recognition of the institution was withdrawn earlier (if the recognition was withdrawn earlier, the details are to be given) :
Date ...................... . Signature: ..................... .
Place ..................... . Full name: .................. .
Seal: Position: ...................... ] '[FORM NO. 3G [Sec rule 52-0(2)] CERTIFICATE OF RECOGNITION No.................... Date of issue ............... .
This is to certify that. ................................ (Name of the institution) ..................... situated at ......................... .is a Recognised Medical Institution to possess, dispense and sell essential narcotic drugs.
2. The institution is a Recognised Medical Institution since ....... (mention date of the certificate issued for the first time) .......... .
3. This certificate shall be in force from ............ to ............ .
4. The certificate is subject to the conditions stated below and to such other conditions as may be specified under the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and the rules made thereunder.
Signature ............................... .
r::>esignation ........................... .
Seal... ..................................... .
Conditions of recognition
1. This certificate is non-transferable.
2. This certificate and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an officer authorised for the purpose by the issuing authority.]
1. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. 5-5-2015).
Form 3-1] The Narcotic Drugs and Psychotropic Substances Rules, 1985 '[FORM NO. 3H (See rule 52R(l)(c)) DAILY ACCOUNTS OF ESSENTIAL NARCOTIC DRUGS TO BE MAINTAINED BY RECOGNISED MEDICAL INSTITUTION Name of the Essential Narcotic Drug Date I. Opening stock :
2. Quantity received :
2(i) Received from (give details) :
2(ii) Consignment Note/Bill/Invoice/Cash Memo, Number etc. :
3. Quantity dispensed :
4. Specify registration number of the patent(s) maintained in :
Form No. 3E and quantity dispensed to each)
5. Closing stock :
98-1 Full Name/Designation (if any) Note:
Signature of the overall in charge
(1) This record shall be maintained on day to day basis and entries shall be made for each day.
(2) Entries shall be completed for each day before the dose of the day.
(3) The pages of the register shall be serially numbered.
(4) Separate record shall be maintained for each essential narcotic drug.
(5) This record shall be retained for two years from the date of last entry.
(6) This record shall be produced before the concerned authorised officers whenever called upon during the course of their inspection/investigation.]
'[FORM NO. 3-1 (See rule 52R(l)(d)] ANNUAL RETURN OF PROCUREMENT/DISBURSEMENT OF ESSENTIAL NARCOTIC DRUGS (TO BE FILLED BY RECOGNISED MEDICAL INSTITUTION) Return for the year : ........................ Date of submitting : . ...................
return l. Number and date of the current certificate of recognition :
2. Name of the Recognised Medical Institution :
St Name of Quantity Quantity Opening Quantity Quality Closing No. essential in original in revised stock procured disbursed stock narcotic annual annual during the to patients drug estimate estimate year during the (if any) year
(1) (2) (3) (4) (5) (6) (7) (8) I. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. 5-5-2015).
98J The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Form 3-1 ~he designated medical practitioner or the over-all in charge, as the case may be, shall record a brief justification where the actual disbursement is more than ten per cent of the estimate or revised estimate, as the case may be.
Full Name/Designation (if any) Signature of the overall in charge.]
'[FORM NO. 3J [See rule 52T(l)] ESTIMATE OF ANNUAL REQUIREMENT OF ESSENTIAL NARCOTIC DRUGS Estimate for the year I : I ..................... Date of submitting 1 = ···················· estimate
1. Number and date of the current certificate of recognition I =I
2. Name of the Recognised Medical Institution I= I
3. Details of the estimated annual requirement of essential narcotic drugs SL Name of Quantity disbursed Estimated Revised Reason for No. essential during previous annual estimated revision narcotic year requirement annual drug requiremenr- (I) (2) (3) (4) (5) (6) *Please attach copy of the original estimate Full Name/Designation (if any) Signature of the overall in charge.]
FORM NO. 4 (See rule 55) Official Seal of the Issuing Authority S. No ...................................................... .
F. No ...................................................... .
GOVERNMENT OF INDIA MINISTRY OF FINANCE (Department of Revenue) CERTIFICATE OF OFFICIAL APPROVAL OF IMPORT (The Narcotic Drugs and Psychotropic Substances Rules, 1985) .................................................. (The Issuing Authority) being the authority empowered to issue Import Certificate under the Narcotic Drugs and Psychotropic Substances Rules, 1985 hereby approves the importation into India of the consignments containing narcotic drugs or psychotropic substances as specified in the Schedule below by- M/s .......................................................................................................................................... .
From M/s ......................................................................................... subject to the condition that the consignment containing such drugs or substances shall be imported before ................... by ................................ to (airport/sea port) in India.
In approving the importation of the consignment containing the said drugs or substances specified ........................................................ (Issuing Authority) is satisfied that it is required solely for medical and scientific purposes.
Address of the Issuing Authority Designation of the Issuing Authority !. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. 5-5-2015).
Form 4A] The Narcotic Drugs and Psychotropic Substances Rules, 1985 98K Schedule specifying the narcotic drugs or psychotropic substances contained in the consignment to be imported.
1. This document is for .............. (The authority to whom and the purpose for which it is being sent to be indicated) .
. 2. The certificate is not valid unless it bears the Official Seal of the Issuing Authority on the top right hand comer.
Official Seal of Issuing Authority S.No ................................................ .
F.No ................................................ .
'[FORM NO. 4A (See rules 54 and 55) (Official seal of the Issuing authority) S. No ........................ .
F. No ........................ .
MINISTRY OF FINANCE (GOVERNMENT OF INDIA (DEPARTMENT OF REVENUE) CERTIFICATE OF OFFICIAL APPROVAL OF IMPORT UNDER THE PROVISO TO RULE 54 (The Narcotic Drugs and Psychotropic Substances Rules, 1985) .................................. , (The Issuing Authority) being empowered to issue Import Certificate under the Narcotic Drugs and Psychotropic Substances Rules, 1985, hereby, approves the importation into India of the following consignments of narcotic drugs:-
(1) ················································;
(2) ················································;
(3) ················································;
By M/s ........................ from M/s ........................ to manufacture formulations for export/for analytical purposes (strike out whichever is not. applicable) subject to the following conditions:- Conditions of import certificate
(i) The consignment containing the drugs shall be imported before ....................... .
by ........................ to (airport/sea-port) in India.
(ii) If the import is for manufacture of formulations for export, the manufacturer shall,-
(a) ensure that no part of the drug imported under this certificate shall be sold or used to manufacture formulations for domestic sale;
(b) ensure that the formulations manufactured out of the drug imported against this certificate shall not be diverted for domestic sale;
(c) furnish to the Narcotics Commissioner and the Drugs Controller General of India details of export of drugs on completion of export along with documentary evidence such as shipping bills, bills of lading and invoices;
(d) obtain transport permit from their State Excise authority /State Food and Drugs Administration permitting transport of their consignment from port of entry to the factory premises;
(e) maintain separate accounts of actual quantity of narcotic drug imported, formulations produced, consignments dispatched and the quantity lying in balance;
I. Ins. by 5.0. 166l(E), dated 13th July, 2010 (w.e.f. 13-7-2010).
98L The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Form 4A
(f) submit a monthly return of receipt/import, consumption and export of the narcotic drug to the Narcotics Commissioner;
(g) follow the procedures prescribed in rules 42, 45, 46 and 47 for security arrangements, maintenance of accounts and submission of returns, possession, sale and distribution of formulations manufactured from the drugs imported under this certificate.
1[(iii) If the import is for analytical purposes, the importer shall,-
(a) ensure that no part of the drug imported under this certificate shall be used for any purpose other than for analytical purpose;
(b) inform the Narcotics Commissioner about the complete utilisation of the Narcotic Drug imported; and
(c) follow the procedures specified in rules 42, 45, 46 and 47.]
3. Any quantity of morphine, codeine, thebaine and their salts or finished formulations for export that have not been utilized shall be surrendered to the Government Opium and Alkaloids Works.
4. This document is for ........................ (TI-.e authority to whom and the purpose for which it is being sent to be indicated).
5. The certificate is not valid unless it bears the Official Seal of the Issuing Authority on the top right hand corner.]
FORM NO. 5 (See rule 58) GOVERNMENT OF lNDJA MINISTRY OF FINANCE (Department of Revenue) AUTHORISATION FOR OFFICIAL APPROVAL OF EXPORT (The Narcotic Drugs and Psychotropic Substances Rules, I 985) .......................................... (The lssuing Authority) being the authority empowered to issue export authorisation under the Narcotic Drugs and Psychotropic Substances Rules, 1985 hereby authorises and permits the fo11owing exportation of Narcotic Drugs or Psychotropic Substances from India:- Exporter ................................................................................................................................... .
Consigned ............................................................................................................................... .
Port of export. ............................................ Port of entry ..................................................... .
Narcotic Drugs or Psychotropic Substances to be exported:
Item No. Number of packages Name of the drug substance I preparations Basic drug substance content The exportation to be made in one consignment from the designated port of export on or before the .................................... day of .................................. (Month), 20 The importation of these drugs into the country of destination has been authorised by official import certificate No................................. dated.................................. issued by ........................ (Authority of the importing country).
Date of Issue ....................... .
Place of Issue ..................... . Designation of the Issuing Authority I. Ins. by G.S.R. 470(E). dated 21st June, 2011 (w.e.f. 21-6-2011).
Form 7] The Narcotic Drugs and Psychotropic Substances Rules, 1985 98M
1. This document is /or ..................................... (the authority to whom and the purpose for which it is being sent is to be indicated).
2. This authorisation is not valid unless it bears the official seal of the Issuing Authority on the top right hand comer.
'[FORM NO. 6) (See rule 67) Date and time of despatch of the consignment.
1. Name and address of consignor (manufacturer/ dealer/ distributor and his Licence No. etc. (Issued under the Drugs and Cosmetics Rules, 1945).
2. Name and address of the consignee (manufacturer/dealer/distributor) and his Licence No. (Issued under the Drugs and Cosmetics Rules, 1945).
3. Description and quantity of the consignment.
(a) (b) (c) Particulars of the drugs with reference to the Schedule(s) to the 1945 Rules, Trade Marks;
Patent and Proprietary Names, etc.
No. of packages. Quantity Gross Net
4. Mode of transport (Particulars of the transporter, Registration Number of the vehicle, R.R. if the Transport is by Railway, etc.,)
5. Date and time of receipt by the consignee and his remarks.
Signature of the consignee with date Signature of the Consignor with date (Name in capital letters) (Name in capital letters) Note.-(1) This Consignment Note should be serially numbered on annual basis.
(2) The Consignor should record a Certificate on the cover page of each book containing consignment note indicating the number of pages contained in such consignment note-book.
(3) The Consignor should maintain a Register showing the details of the books of consignment notes brought in use during a particular year.
(4) The books containing consignment not used or currently under use and the register as referred to at item (3) have to shall be produced to the officers whenever called upon during the course of their inspections.
'[FORM NO. 7 (See rules 35, 53, 64 and 67 A) 3[1. Name of the laboratory /research institution/hospital/dispensary /person/ authority]
2. Address
3. Name of the Drug
4. From whom the drug was obtained/purchased
1. Form No. 6 deleted and Form No. 7 re-numbered as Form 6 by G.S.R. 556 (E), dated 14th July, 1995 (w.e.f. 20-7-1995).
2. Ins. by G.S.R. 350(E), dated 25th June, 1997 (w.e.f. 27-6-1997).
3. Subs. by G.S.R. 905(E), dated 28th December, ?011, for item I (w.e.f. 28-12-2011).
98N The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Fomi 7 1(5. Quantity obtained/purchased)
6. Date on which obtained/purchased Details of Use:
SI. No. Date Quantity consumed Purpose Signature of the user Note.- (!) This form shall be kept for 2 years from the last date of consumption.
SI.
(2) This shall be produced for verification by any of the officers empowered under section 41 or 42 of the Narcotic Drugs and Psychotropic Substances Act or any officer-in-charge of a police station.]
'[FORM NO. 8 (See rule 67B) APPLICATION/REQUISITION FOR STANDARD SAMPLES OF NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES I. Name of the Organisation or Agency
2. Full postal address of the Organisation or Agency
3. Purpose for which sample of standard Narcotic drug or Psychotropic Substances is required
4. Name and quantity of standard sample required
5. Name and designation of officer under whose custody the samples shall be kept
6. Copy of Stock Register of narcotic samples maintained by th&organisation duly verified by the controlling officer
7. Other relevant information (if any) Signature ............................. .
Designation ......................... .
of Indenting Officer with Rubber Stamp] '[FORM NO. 9 [See rule 67B(S)] ANNUAL REPORT TO THE CHIEF CONTROLLER OF FACTORIES ON RECEIPT, CONSUMPTION AND BALANCE OF SAMPLES OF NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES Narcotic drug/ Opening Receipt Consumption Closing Balance No. Psychotropic substance Balance Signature ............................. .
Designation ......................... .
of Indenting Officer with Rubber Stamp.]
1. Subs. by G.S.R. 905(E), dated 28th December, 2011, for item 5 (w.e.f. 28-12-2011).
2. Ins. by G.S.R. 639(E), dated 13th October, 2006 (w.e.f. 13-10-2006).