Narcotic Drugs Controlled under Indian NDPS Act

 

"Narcotic Drug" means coca leaf, cannabis (hemp), opium poppy straw and including all manufactured drugs;

"Manufactured Drugs" means

(a) all coca derivatives, medicinal cannabis, opium derivatives and poppy straw concentrate;

(b) any other narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature, or to a decision, if any, under any International Convention, by notification in the Official Gazette declare to be manufactured drug;

(Govt. of India's Notifiction S.O. 826(E) dated 14/11/1985 and S.O. 40(E) dated 29/01/1993 & S.O. 1431(E) dated 21/06/2011) wherein the Central Government has declared certain narcotic drugs and preparations to be manufactured drugs. According to these notifications preprations, admixtures, extracts or other substances containing any of these drugs also come under the definition of manufactured narcotic drugs.

"Psychotropic Substances" means any substance, natural or synthetic, or any natural material or any salt or preparation of such substance or materials included in the List of Psychotropic Substances specified in the Schedule  to the NDPS Act, 1985.

"Poppy Straw" means all parts (except the seeds of the Opium poppy after harvesting whether in their original form or cut, crushed or powdered and whether or not juice has been extracted therefrom;

"Controlled Substance" means any substance which the Central Government may, having regard to the available information as to its possible use in the production or manufacture of narcotic drugs or psychotropic substance or to the provisions of any International Convention, by notification in the official gazette, declare to be a controlled substance.

 

Export/ Import

Any narcotic drugs or psychotropic substances can be imported into/ exported out of India subject to Rule 53 and Rule 53-A of the NDPS Rules, 1985.

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 under the provision of Rule 54 of the NDPS Rules, 1985.

The import into and export out of India of any narcotic drugs or psychotropic substances specified in Schedule I  is prohibited under the provision of Rule 53 of the NDPS Rules, 1985.

The export of any narcotic drugs or psychotropic substances or preparations containing any of such narcotic drugs or psychotropic substances specified in Schedule II  shall be prohibited to the countries or to the region of such country specified therein under the provision of Rule 53-A of the NDPS Rules, 1985.

The manufacture of psychotropic substances specified in Schedule III  can be allowed for export purpose only under the provision of Rule 65(1) of the NDPS Rules, 1985. The import of psychotropic substances specified in Schedule III may be allowed for test/ analysis purpose as well as for re-export purpose.

The export out of / import into India of a select number of Precursor Chemicals  is exercised by the Narcotics Commissioner in accordance with Directorate General of Foreign Trade (DGFT) notification  and Administrative Control. Any company/applicant desirous of obtaining No Objection Certificate for export of notified precursor Chemicals are required to apply to the Narcotics Commissioner

Status of Control over Import and Export

 

Manufacture of Natural Manufactured Drugs - Under Rule 36 of the NDPS Rules, 1985

1.    The manufacture of cocaine and its salts is prohibited save the manufacture of cocaine hydrochloride by the chemical staff employed under the Central Board of Excise and Customs from confiscated cocaine.

2.    The manufacture of morphine, codeine, dionine, thebaine, dihydrocodeinoe, dihydrocodeine, acetyldihydrocodeine, acetyldihydrocodeinone, dihydromorphine, dihydromorphinone, dihydrohydroxy codeinone, pholcodine and their respective salts is prohibited save by the Government Opium Factory.

Manufacture of Synthetic Manufactured Narcotic Drugs - Under Rule 37 of the NDPS Rules, 1985

1.    The manufacture of manufactured drugs notified under Govt. of India's Notifiction S.O. 826(E) dated 14/11/1985 and S.O. 40(E) dated 29/01/1993 & S.O. 1431(E) dated 21/06/2011 is prohibited save under and in accordance with the conditions of a licence granted by the Narcotics Commissioner or such other officer as may be authorised by the Central Government in this behalf, if Form No. 3 appended to NDPS Rules, 1985. (Circular F. No. 08/01/Narco/2012 dated 09th August, 2012 issued by CBN)

(Please click here to download the application for the manufacture of formulations of Synthetic Narcotic Drugs (Rule 37 or Rule 38 of the NDPS Rules, 1985)

 

   

Procedure followed for processing  of applications / requests  from companies for above functions

 

(I) Manufacturing Licence/Renewal of Manufacturing licence

 

Any company/applicant  desirous to manufacture  any synthetic narcotic drugs shall applied to the Narcotics Commissioner in  a prescribed manner  and shall submit the  documents detailed at (I)  of  Annexure.

 

The manufacture of Narcotic drugs is governed by estimate system. While allowing the manufacturing licence, it is ensured that the total quantity of drug allowed to be manufactured during any year does not exceed the annual estimated requirements of India as furnished and subsequently published by to the International Narcotics Control Board, Vienna, Austria.

 

As regards renewal of manufacturing licence, the manufacturers  are  required to apply  to the Narcotics Commissioner at least 30 days before the expiry of his license alongwith documents detailed at (II) of Annexure.

 

On the basis of the demand made by the manufacturers and keeping in view of their performance i.e. internal consumption and export of the drug, the manufacturing licenses are renewed for the suitable quantities within the estimates of that drug for the year.

 

(II) Export Authorisations for export of Narcotic Drugs and Psychotropic Substances

 

Any  company/applicant desirous of obtaining  Export Authorisation shall apply to the Narcotics Commissioner in a prescribed manner and shall submit the documents detailed at (III) of Annexure.

 

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of such Export Authorisations shall also be submitted along with the application which are detailed at (VII) of Annexure.

 

The export of narcotic drugs and Psychotropic substances are governed by estimate system. While allowing Export Authorisation, it is ensured that the annual estimated requirement in respect of a particular narcotic drugs and psychotropic substances ( as published by INCB, Vienna, Austria) does not exceed the estimated requirement in respect of the importing country. Such export authorisation are allowed by  Central Bureau of Narcotics subject to following conditions :-

 

a.   Any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.

b.   The shipment should be made in one consignment within the validity of the Export Authorisation.

c.   The exporter are required to submit export details immediately after effecting export.

 

 

(III) Import Certificate for Import of Narcotic Drugs and Psychotropic Substances

Any company/applicant desirous of obtaining import certificate shall apply in a prescribed manner submitting the documents detailed at (IV) of Annexure.

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of import Certificates shall also submit the documents detailed at (VII) of Annexure.

 

The import of narcotic drugs and Psychotropic substances are governed by estimate system. While allowing Import Certificate, it is ensured that the estimated  requirement  of a particular narcotic drug and psychotropic substance  ( as reported to the INCB and subsequently published by INCB) does not exceed the requirement in respect of India. Such import Certificates are granted subject to condition that the importer will submit the import details immediately after effecting import and any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.

 

In exercise of the powers conferred by the provisio to rule 54 of the NDPS Rules, 1985, the Central Government hereby notifies the following manufacturers (mentioned in the Gazette Notification) to import of morphine, codeine, thebaine and their salts for use in manufacture of products to be exported or for importing small quantities of morphine, codeine and thebaine and their salts not exceeding a total of 1 kilogram during the financial year for analytical purposes after following the procedure under rule 55 of the said rules and subjects to such conditions as may be specified in the import certificate issued in Form No. 4A.

 

(IV)  No Objection Certificate (NOC) for export of Precursor Chemicals

 

Any company/applicant desirous of obtaining NOC for export of select precursor Chemicals are required to apply to the Narcotics Commissioner in a prescribed manner submitting the documents detailed at (V) of Annexure.

 

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of such NOC shall also submit the documents detailed at (VII) of Annexure.

 

The export of Precursor Chemicals are governed by System of Pre- Export Notification (PEN). This office uses a system of PEN to verify the genuineness of the transaction and to notify the Competent Authority of the importing and transhipping country of the impending export.  Such NOCs are allowed by  Central Bureau of Narcotics subject to following conditions :-

 

a.  Any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.

b.  The shipment should be made in one consignment within the validity of the NOC.

c.  The exporter are required to submit export details immediately after effecting export.

 

 (V) No Objection Certificate (NOC) for import of Precursor Chemicals

 

Any company/applicant desirous of obtaining NOC for import of a select number of precursor chemical, are required to apply to the Narcotics Commissioner in a prescribed manner along with the documents detailed at  (VI) of  Annexure.

 

Apart from the above documents, additional information in respect of companies approaching this office for the first time for grant of such NOC shall also be submitted which are detailed at (VII) of Annexure.

 

Such import NOC's are granted subject to condition that the importer will submit the import details immediately after effecting import and any kind of amendment as well as extension in validity of Export Authorisation would not be allowed.

 

(VI) Registration for import of Poppy Seeds

 

Any company/applicant desirous of importing poppy seeds shall apply to the Narcotics Commissioner in a prescribed manner along with the documents detailed at (IX) of Annexure.

 

Apart from the above documents, additional information / documents  in respect of applicants approaching this office for the first time  for registration are also required to submit documents detailed at (IX) of Annexure.

 

While registering contracts for import of poppy seed, it is ensured that the conditions of the Ministry of Commerce and Industry, Department of Commerce, Notification No.27(RE-2000)/1997-2002 dated 1.8.2000 and subsequent import policy & import policy conditions framed under EXIM-Policy (Please refer import licensing note (3) issued under Chapter-12 of the EXIM-Policy, 2004-09) are complied with.

 

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Annexure

 

(I) List of Documents to be submitted for grant of Manufacturing Licence

  1. Application form in the prescribed format.

  2. A fee of Rs.5000/-  in form of a Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

  3. Copy of licence granted under the rules framed under section 10 of the State Narcotic Drugs and Psychotropic Substances Act by the State Govt. of the State in which the company have place of business, for the possession, sale, and distribution of the drugs.

  4. Copy of valid Drug Manufacturing Licence issued by the State Drug Controller/ Food and Drug Administration (FDA) under the Drugs and Cosmetics Act/ Rules.

  5. List of approved technical person in the production and quality control.

  6. List of Directors.

  7. List of Laboratory equipments and raw materials.

  8. Copy of site plants.

  9. Original National Saving Certificate of Rs. 5000/- as Security Deposit.

  10. Balance Sheet of Company for the last 3 years.

  11. Flow Chart of manufacturing process and per annum capacity.

(II) List of Documents to be submitted for Renewal of Manufacturing licence

  1. Application form for renewal of manufacturing licence in prescribed format.

  2. Renewal fee of Rs. 5000/ -  in favour of Drawing and Disbursing Officer, Central Bureau of Narcotics, Gwalior.

  3. Renewed licence granted to the manufacturer  under the Drugs and Cosmetics Act, 1940 (23 of 1940) for the manufacture of the drug.

  4. Renewed licence granted to the manufacturer under the rules framed  under Section 10 of the Act  by the State Govt.  of the state  in which the manufacturer has  place of business, for the possession, sale and distribution of the drug.

  5. Statement of annual production & consumption in prescribed format.

(III) List of Documents to be submitted for grant of Export Authorisations for export of Narcotic Drugs and Psychotropic Substances

  1. Application  form and the Background information  in the prescribed format for export of Narcotic Drugs or Psychotropic Substances and their salts.

  2. Original Import Certificate issued by the Govt.  of the importing country certifying the official approval of the concerned Govt.

  3. Licence Fee of Rs. 1000/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

  4. Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer on loan licence) and copy of valid drug licence for sale, distribution or exhibit (in case of merchant exporter).

  5. Copy of the purchase  order placed by the foreign buyer for the proposed import.

  6. Original Transport permit issued by the State Excise Authority (in case of Narcotic Drugs)

 

(IV) List of Documents to be submitted for grant of Import Certificate for Import of Narcotic Drugs and Psychotropic Substances

  1. Application  form and the Background information  in the prescribed format for import of Narcotic Drugs or Psychotropic Substances and their salts.

  2. Licence Fee of Rs. 1000/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

  3. Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer on loan licence) and copy of valid drug licence for sale, distribution or exhibit (in case of merchant exporter).

  4. Original Test Licence/Import Licence from Drug Controller General (India) for the proposed import.

  5. Copy of import-export contract with the overseas supplier.

  6. Original Transport permit issued by the State Excise Authority (in case of Narcotic Drugs).

(V) List of Documents to be submitted for grant of No Objection Certificate (NOC) for export of Precursor Chemicals

  1. Application  form and the Background information  in the prescribed format for export of select precursor chemicals and their salts.

  2. Original Import Certificate issued by the Govt.  of the importing       country certifying the official approval of the concerned Govt.

  3. Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

  4. Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer) and copy of valid drug licence for sale, distribution or exhibit (in case of merchant exporter).

  5. Copy of the purchase  order placed by the foreign buyer for the proposed import.

 

(VI) List of Documents to be submitted for grant of No Objection Certificate (NOC) for import of notified Precursor Chemicals

  1. Application  form and the Background information  in the prescribed format for import of select Precursor Chemicals and their salts.

  2. Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

  3. Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer) and copy of valid drug licence for sale, distribution or exhibit (in case of merchant exporter).

  4. Original Test Licence/Import Licence from Drug Controller General (India) for the proposed import.

  5. Copy of import-export contract with the overseas supplier.

(VII)  List of Documents to be submitted by first time exporter/import of Narcotic Drugs, Psychotropic Substances and Precursor Chemicals.

  1. Complete postal address and telephone, fax no. of various factories of the company manufacturing Narcotic Drugs and Psychotropic Substances including Jurisdictional Central Excise division and Central Excise Commissionerate and Zonal office of Narcotics Control Bureau in respect of factories.

  2. List of Narcotic drugs and Psychotropic Substances being    manufactured by the company and details of manufacture of Narcotic drugs and Psychotropic Substances by the company in the last three calendar years (1st January to 31st December).

  3. Details of export/import of Narcotic drugs and Psychotropic Substances by  the company during the last three calendar years (1st January to 31st December).

  4. Name, address, telephone Nos. and Fax No. of the Chairman, Managing Director and other Directors, proprietor/ partners, in charge of production and finance.

  5. Sales Tax Registration No., Central Excise Registration No. and Company’s PAN No. (Attested copies of  these documents shall also be submitted.)

  6. Name of concerned Jurisdictional Commissionerate of Customs and Central  Excise.

  7. Balance Sheet of Company for last 3 years.

  8. Amount of Excise Duties paid by company during last three years.

  9. Profile of the company.

(VIII) List of Documents to be submitted for grant of Registration for import of Poppy Seeds

  1. Application  form and the Background information in the prescribed format.

  2. Original Sales Contract/ Export-Import Contract

  3. Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.

(IX) List of Documents to be submitted by first time importer of Poppy Seeds

  1. Whether the firm have imported poppy seed earlier . If, yes mention the year, quantity and name of exporting  country.

  2. Annual turn-over of the firm.

  3. The items, in which the firm deals with.

  4. Income Tax return for last three years with PAN Number (certified copies shall be submitted)

  5. Name of the Jurisdictional  Commissionerate of Central Excise under  which  the  firm lies.  In case registered with Central Excise, the copy of registration  may also be submitted.

  6. Full address of the company, factory and warehouse.

  7. Copy of Registration/Import-Export Code No. issued by the DGFT.

  8. Copy of Spices Board Registration

  9. Balance Sheet of Company for last 3 years.