Manufacturing License

The manufacture of manufactured drugs notified under sub-clause (b) of clause (xi) of section 2 of the Act 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, in prescribed form.

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 herein.

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 along with documents detailed herein for Renewal.

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.

• Application form in the prescribed format.


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


• 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.


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


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


• List of Directors.


• List of Laboratory equipments and raw materials.


• Copy of site plants.


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


• Balance Sheet of Company for the last 3 years.


• Flow Chart of manufacturing process and per annum capacity.

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


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


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


• 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.


• Statement of annual production & consumption in prescribed format.