Drug License in India: Wholesale & Retail (Form 20 & 21) Explained
Selling drugs, certain cosmetics and pharma products in India requires a licence under the Drugs and Cosmetics Act, issued by the State Drugs Control Department.
Types of licence
- Retail (Form 20/21): to sell to end consumers (pharmacies)
- Wholesale (Form 20B/21B): to distribute to retailers/institutions
- Import licence (Form 10) for importing drugs
Key requirements
A qualified person is mandatory โ a registered pharmacist for retail, or a competent person for wholesale โ along with adequate premises area and refrigeration for certain products.
Cosmetics & devices
Imported cosmetics need CDSCO registration; many medical devices now fall under CDSCO's device rules. Classification decides the pathway.
Statura handles drug licensing and CDSCO registrations for importers and traders.