Narcotics Regulatory Affairs

Narcotics Regulatory Affairs

The word narcotic comes from Greek word “narkos” meaning sleep. Specifically, narcotics includedrugs like heroin, morphine, coca leafs, cannabis (hemp), opium poppy straw and other related drugs.Any narcotic drugs and psychotropic substances can be manufactured, imported into/ exported out of India subject to Rule 53 and Rule 53-A of Narcotic Drugs and psychotropic substances Act, 1985 (NDPS Act, 1985). A specific permission from Central Bureau of Narcotic (CBN), Gwalior, Madhya Pradesh, India. Extremely stringent guidelines have been laid down by the Indian government to ensure that their sale and manufacture is regulated.

Manufacturing License

Any pharmaceutical company wishing to manufacture any synthetic narcotic drugs must apply to the Narcotics Commissioner in a prescribed manner and shall submit the documents mentioned in (I) of Annexure.

The estimate system is used to govern the manufacture of Narcotic drugs. When the manufacturing licence is allowed, it is confirmed that the total amount of the drug allowed to be manufactured during any year does not exceed the total annual estimated requirements of India as provided and successively published by to the International Narcotics Control Board, Vienna, Austria.

For the renewal of manufacturing licence, the manufacturers are requisite to apply before 30 days of expiry of his license along with documents mentioned in (II) of Annexure at the Narcotics Commissioner.

By keeping in view of the performance of manufacture according to their demand 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.

Narcotic and Psychotropic Drugs

Narcotic drugs are those that cause the person to experience insensibility to pain, stupor, or go into a coma. Psychotropic drugs are those that cross the brain and blood barriers affecting the nervous system to cause alternations to brain function and cognitive, behavioral, mood, perceptional, conscious perceptions.

Export NOC/Certificate

Any pharmaceutical company looking to obtain the Export Authorisation shall apply in a prescribed manner and shall submit the documents detailed at (III) of Annexure at Narcotics Commissioner.

Some additional information in respect of companies approaching the following office for the first time for grant of such Export Authorisations shall also be submitted along with the application in detail at (VII) of Annexure.

The export of narcotic drugs and Psychotropic substances is ruled by the Estimate system. When Export Authorisation is granted, the annual estimated requirement in respect of a particular narcotic drugs and psychotropic substances (as published by INCB, Vienna, Austria) cannot exceed the estimated requirement in respect of the importing country. These export permissions are permitted by the Central Bureau of Narcotics under the following conditions:

  1. Any kind of extension as well as modification in validity of Export Authorisation is not allowed.
  2. The delivery should be made in one consignment within the validity of the Export Authorisation.
  3. The export details are required to submit by the exporter immediately after effecting export.

Import NOC/Certificate

Any pharmaceutical company eager for obtaining an import certificate shall apply in a prescribed manner and submit the documents details at (IV) of Annexure. Apart from these documents, some other information with respect to 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 is administrated by estimate system. When the Import Certificate is allowed, it is confirmed that the projected requirement of a particular narcotic drug and psychotropic substance (as reported to the INCB and subsequently published by INCB) does not cross the limit of requirement in respect of India.

The import license is granted only under following conditions:

  1. The importer of narcotic drug and psychotropic substances will submit all the import details as soon as possible after effecting import.
  2. And any kind of extension and amendment in validity of Export Authorisation will not be allowed.

According to rule 54 of the NDPS Rules, 1985, the Central Government hereby informs the manufacturers to import codeine, morphine, the baine and their derivatives for use in manufacturing of products to be exported or for importing small quantities of codeine, morphine, and the baine and their salts not above a total of 1 kilogram throughout the financial year for analytical purposes after following the practice under rule 55 of the said rules and subject to such conditions as may be specified in the import certificate issued in Form No. 4A.

NOC for Import/Export of Precursor Chemicals

NOC for Import

Any pharmaceutical company/applicant wishing to obtain the NOC for import of selected number of precursor chemicals is required to apply to the Narcotics Commissioner in a prescribed manner along with the documents mentioned in (VI) of Annexure. Some additional data with respect to companies approaching the following office for the first time for grant of such a NOC must also be submitted as detailed in (VII) of Annexure.

Such import NOCs are granted under following conditions:

  1. The importer will submit the import details immediately after effecting import
  2. The change of any kind as well as extension in validity of Export Authorisation would not be allowed.
NOC for Export

Any pharmaceutical company/applicant looking to obtain the NOC for export of selected number of precursor chemicals is required to apply to the Narcotics Commissioner in a prescribed manner along with the documents mentioned in (V) of Annexure.

Some additional data with respect to companies approaching the following office for the first time for grant of such NOC must also be submitted as detailed in (VII) of Annexure.

The System of Pre-Export Notification (PEN) governs the export of Precursor Chemicals. This office uses a system of PEN to verify the authenticity of the transaction and to notify the Competent Consultant of the importing and transhipping country of the impending export. Such NOCs are granted by Central Bureau of Narcotics under following terms and conditions:

  1. Any kind of extension as well as amendment in validity of Export Authorisation will not be allowed.
  2. The importer will submit the import details immediately after effecting import
  3. The shipment should be made in one consignment within the validity of the NOC.

Why CliniExperts?

  1. Our Global Regulatory Affairs team at CliniExperts includes a network of professionals across the globe dedicated to keeping you aligned with the latest local and national regulatory developments.
  2. We provide highly qualified support personnel for the registration of narcotic drugs and psychotropic substances that can be manufactured, imported into/ exported out of India to overcome the challenges associated with renewal under Narcotic Drugs and psychotropic substances Act, 1985.
  3. We help our clients in filling Form according to Rule 53 and Rule 53-A, which is an essential requirement of the renewal procedure.
  4. Our experienced regulatory professionals help in License extensions, maintenance and renewals with high confidentiality.

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