Drug License (Form 20/21)

Wholesale and retail sale of drugs in India requires a licence under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, issued and administered by the State Drug Controller (State Licensing Authority) of the state where the premises are located.

Under Rule 61 of the 1945 Rules, a retail-sale licence for drugs other than those specified in Schedules C, C(1) and X is issued in Form 20 (with Form 20-A/20-B variants for restricted or other retail categories). A licence to sell, stock, exhibit, or distribute drugs specified in Schedules C and C(1) — excluding Schedule X — by retail or wholesale is issued in Form 21 (with Form 21-A/21-B variants, the latter covering wholesale of biological products). Applications are made in the prescribed form (Form 19 or 19-C, depending on category) to the State Licensing Authority, accompanied by the prescribed fee, and are granted subject to conditions on premises (minimum area), storage (including cold-chain facilities for Schedule C/C(1) biologicals), and the mandatory engagement of a qualified pharmacist or competent person as per the Rules.

Separate licences apply for manufacture (Forms 25/28 etc.) and for Schedule X (narcotic and psychotropic) drugs, which fall outside the Form 20/21 wholesale-retail regime described here and require additional, more stringent authorisation. Licence validity, renewal timelines, and specific premises/qualification thresholds are prescribed at the state level under each state's drug-licensing rules framed pursuant to the central Act and Rules, so exact conditions should be confirmed with the relevant State Drug Controller before an application is filed.

We assist with documentation and application support for drug retail/wholesale licensing, including pharmacist/competent person documentation and premises compliance. Requirements vary by state drug control department and business model.