Drug License in India

The first question is never how to apply — it is which licence your business activity requires, because the wrong application wastes weeks and a rejection resets the clock. A retail pharmacy selling to consumers needs a retail licence (Form 20/21). A distributor or stockist selling to other businesses needs a wholesale licence (Form 20B/21B). A company physically making formulations needs a manufacturing licence (Form 25 for non-biologicals, Form 28 for biologicals). And a business importing finished drugs needs a central import licence through CDSCO, not a state licence at all.

Many businesses need more than one. A manufacturer that also distributes its own products, or a chain that both stocks and retails, will hold multiple licences at once. We map every activity in your business model to the licence it triggers at the outset, so nothing surfaces later as an unlicensed operation that customs, an inspector, or a tender authority can flag.

• Retail sale to consumers — Form 20/21 (retail drug licence), requires a registered pharmacist.
• Wholesale / distribution — Form 20B/21B, requires a competent person with prescribed qualifications.
• Manufacturing — Form 25 (non-biological) or Form 28 (biological), requires Schedule M compliance.
• Import of finished drugs — central CDSCO import licence, not a state licence.

A drug licence is granted against a specific premises and a specific qualified person, and both are inspected before approval. For retail and wholesale licences, the State Drug Controller's inspector verifies the physical area (minimum floor space is prescribed), storage and refrigeration for temperature-sensitive drugs, and the presence and qualification of the pharmacist or competent person named on the application. Gaps here — an under-sized premises, a missing cold-chain unit, or a pharmacist whose registration is not current — are the most common reasons a licence is held up.

Manufacturing licences add a further layer: Schedule M Good Manufacturing Practices. The inspection reviews facility design, cleanroom classification, HVAC and air-change rates, water systems, and documented quality procedures. We prepare the site, documentation and SOPs to Schedule M before the inspection, and provide mock-audit support, so the licensing visit is a confirmation rather than a discovery of gaps. This front-loaded approach is what keeps a manufacturing licence moving through the 60-to-90-day window rather than looping through repeated re-inspections.