NARCOTICS

REGULATORY SERVICES

Under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Rules) the sale and distribution of Narcotic drugs or psychotropic substances in India is Regulated by the Central Bureau of Narcotics, Gwalior, Madhya Pradesh India. NKG team has been providing a clear regulatory pathway to companies active in Import or Export or Manufacture of various types of Narcotic Drugs or psychotropic substances.

NARCOTICS DRUGS & PSYCHOTROPIC SUBSTANCES

As per the Narcotic Drugs and Psychotropic Substances Act, 1985 various provisions relating to import and export of Narcotic Drugs and Psychotropic Substances are clearly laid out. These provisions are as follows:

  • Narcotic drugs or psychotropic substances [defined under section 2 (xiv) and section 2(xxiii) of NDPS Act, 1985] can be imported into/ exported out of India subject to Rule 53 of NDPS Rules 1985 provided that import into India or export out of India of narcotic drugs and psychotropic substances specified in Schedule I of these rules shall be for the purpose mentioned in Chapter VII A.
  • 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.
  • The import or morphine, codeine, thebaine and their salts by manufacturers notified by the Government for manufacture of products to be exported or to import small quantities of morphine, codeine and thebaine and their salts not exceeding a total of 1 kg. in a calendar year for analytical purposes is permitted after following the procedure under rule 55 and subject to the conditions as may be specified by the Narcotics Commissioner.

Rule 55 and Rule 58 of NDPS Rules 1985

As per Rule 55 & Rule 58 , No narcotic drug & psychotropic substance as specified in the NDPS ACT & RULES can be imported into India or Exported out of India without an valid Import Certificate or an Export Authorisation issued by the Narcotics Commissioner, Central Bureau of Narcotics, Gwalior.

NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES

IMPORT CERTIFICATE & EXPORT AUTHORISATION

As per Rule 55(3) and rule 58(3) of the NDPS rules,1985, Each application for Export or Import of the Narcotics Drugs or Psychotropic substances has to be submitted to Narcotics Commissioner with a Fees INR 1000/-.

Applicant for seeking grant  of IMPORT CERTIFICATE for import of Narcotic Drugs will apply in the application form specified as “IMP-1” alongwith the Background Information specified as “IMP-2”
Application for seeking grant of EXPORT AUTHORISATION for export of Narcotic Drugs the applicant will apply in the application form specified as “EXP-1” alongwith the Background Information specified as “EXP-2”
CHECKLIST OF DOCUMENTS FOR NARCOTICS
  1. Complete Name and Address of Indian Importer
  2. CBN Registration No. : (for psychotropic substances)
  3. Complete Name and Address of Exporter of Said Substances
  4. Details of Substances to be imported  with Details as Substance Name, Quantity and Active Content
  5. Port of Entry into India along with Custom office
  6. Complete Name of Port of Exporting country with Mode of Transport
  7. Import License issued by DCGI / Advance Authorization issued by DGFT( Not Required for Precursor Drugs)
  8. Details of confirmed Proforma Invoice/ Sale Order with Cost per unit, Total cost and means of payment
  9. Copy of Drug License Issue by State Licensing Authority
  10. Permit No, Validity OF State Excise permit

Post grant of above permissions, The concerned Importer or Exporter of such Narcotic Drugs & Psychotropic Substances are required to mandatorily submit monthly report of Actual Import or Export during a particular month  in the “Return Import” or Return Export” formats issued by CBN respectively.

MANUFACTURE OF PSYCHOTROPIC SUBSTANCES

No person shall manufacture any of the psychotropic substances defined under section 2(xxiii) of NDPS Act, 1985, except in accordance with the conditions of a licence granted under the Drugs and Cosmetics rules,1945 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. Besides, every manufacturer of psychotropic substances is also required to register with the Narcotics Commissioner in terms of the Rules 65 of the NDPS Rules.

On Issuance of the Certificate to Manufacture the Said psychotropic substance, The Licensing Authority Shall Intimate the License holder the permitted Quantity which can be manufactured.

As per rule 67A of NDPS Rules,1985 manufacture, possession, transport, import-export, Purchase and consumption of narcotic drugs and psychotropic substances in “Schedule I” is permitted only for medical, scientific and training purposes.

The License holder has to submit Quarterly reports on website of http://www.cbnonline.gov.in/ and submit reports of Substances Manufactured of each substance. The return for a quarter shall be filed before the last day of the month following that quarter. If the return for a quarter is not filed before the due date by an applicant registered, the Narcotics Commissioner may issue notice to the concerned applicant.

Licensing authority Shall revoke the Registration, if the quarterly return for three successive quarters is not filed.

NO OBJECTION CERTIFICATE (NOC)

EXPORT OF PRECURSOR CHEMICALS

Any one who intends to export a controlled substance in Schedule-B shall apply to the Narcotics Commissioner in Form-J for a No Objection Certificate along with the documents detailed in Form J for export along with additional documents appended in Form J for export in case of first time exporter.

The export of Precursor Chemicals are governed by the 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.  The export of a controlled substance are allowed against the NOC issued by the Narcotics Commissioner subject to following conditions:

  1. Any kind of amendment as well as extension in validity of export NOC shall not be allowed.
  2. The shipment shall be valid for a single consignment only .
  3. The exporters are required to submit export details and the documents relating to export within seven days of export.
NO OBJECTION CERTIFICATE (NOC)

IMPORT OF PRECURSOR CHEMICALS

Any one who intends to export a controlled substance in Schedule-C shall apply to the Narcotics Commissioner in Form K for import for a No Objection Certificate along with the documents detailed in Form-K along with additional documents appended in Form J for export in case of first time exporter.

The import of a controlled substance are allowed against the NOC issued by the Narcotics Commissioner subject to following conditions :-

  1. Any kind of amendment as well as extension in validity of import NOC shall not be allowed.
  2. The shipment shall be valid for a single consignment only .
  3. The exporter are required to submit import details and the documents relating to import within seven days of export.

Narcotics Regulatory Affairs