Drug Licence

Drug License is required for the manufacturers of drugs and cosmetics sold in India to ensure its conformity with the regulations of India

Drug License Consultant in Delhi NCR

The Drugs and Cosmetic Act, 1940 is an act which regulates the import, manufacture and distribution of the drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. The related Drugs and Cosmetic Rules 1945 contains provisions for classification of drugs under given schedules and their guidelines for the storage sales, display and description of each schedule. This act also covers all the regulations of Ayurveda siddha and Unani drugs.

The admittance to medicines and drugs is restricted and regulated to ensure that such goods are not abused or misused by the individuals. All pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs and cosmetics, ayurvedic, siddha and unani drugs have to mandatorily obtain drug licenses under the Drugs and Cosmetic Act, 1940

In India, drug controlling authorities i.e., State Drugs Standard Control Organization (SDSCO), Central Drug Standard Control Organization (CDSCO), and Department of Ayush are responsible to issue the different drug licenses. The business operates in different states, a license is mandatory for each location.


Pharmaceuticals business in India requires following types of licenses: –

  1. Import License: –

    Under Schedule X Drugs & Cosmetics can be imported to India only after obtaining a license. For import purpose drugs as well as manufacturing unit should be registered.

  2. Manufacturing license

    Manufacturing licenseis a granted to the manufacturing of allopathic and Ayurvedic Drugs and cosmetic products. Various type of manufacturing licences are Test Licence for manufacturing, post successful clinical trial manufacturing License, Notified medical devices manufacturing license.

  1. Whole Sale Drug Licence :

    A wholesale licence is issued to the company/distributor/independent agent who can be an authorized Indian agent for the local or foreign manufacture. Or we can say that the wholesale license is issued to the manufacture and authorized Indian representative.

  2. Retail Sale Drug License (Chemist Shop)

Retail sale refers to the sale of the drugs to the end consumer. Retailers can sell drugs to a hospital, dispensary, medical, education, or research institute etc. Under the Drugs and Cosmetic Act, a drugs license is mandatory for the retailers of drugs or chemist shops. And

a retail license is issued by the Drug controller Authority of the state In case any person sells drugs without of the license, he shall be punishable with imprisonment for the term of not less than 1 year and may extend up to 3 years with a fine up to Rs 5000

  1. Restricted Licence for Drugs:

    Under Form 20A and 21A this license is issued to those applicants who want to sell drugs without the supervision of a competent individual

  1. Loan Drug Licence:

    According to the drug and cosmetic act “A loan license means a license which a licensing authority may issue to an applicant who doesn’t have its own arrangement of manufacturing but who intends to avail himself of the manufacturing facilities of a license.

  2. Multi-drug license:  Multi drug licences issued to business, who operate their business in multiple states with the same name. One cannot sell drug in more than one state without a multi-drug license.


Getting drug licences requires various formalities which need to be fulfilled before filing of the application. We, Osgan-QMS Consultant in Delhi NCR offer complete (end to end services) solution to importer of drug, manufacturer, wholesalers, retailers for obtaining the licences within reasonable/ reduced time period. You can email to us at [email protected] for more details or assistance.

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