# Drug Licence — Retail & Wholesale

> Selling or distributing medicines needs a drug licence from the State Drugs Control authority under the Drugs and Cosmetics Act, 1940. Retail pharmacies get licences in Forms 20 and 21 and wholesalers in Forms 20B and 21B. A retail outlet needs a registered pharmacist, a wholesaler needs a 'competent person' with the prescribed qualification and experience, and the premises must meet minimum area and storage requirements, including refrigeration where needed.

Practice: Business Licences & Registrations — https://www.industax.com/services/business-licences/

The premises are inspected before the licence is granted, so the work starts with the layout: minimum carpet area (10 square metres for retail or wholesale, 15 for both together), separate storage, refrigeration for cold-chain products, and clear display of the licence and pharmacist's details.

Licences no longer need periodic renewal; instead a retention fee is paid every five years. We prepare the application, the pharmacist or competent person's documents, and help you through the inspection and later compliance such as Schedule H1 records.

## Key facts

| Item | Detail |
| --- | --- |
| Law | Drugs and Cosmetics Act 1940; Rules 1945 |
| Retail | Forms 20 and 21 (registered pharmacist) |
| Wholesale | Forms 20B and 21B (competent person) |
| Minimum area | 10 sq m (retail or wholesale); 15 sq m for both |
| Validity | Perpetual, with retention fee every 5 years |

## Who needs this

- New pharmacies and chemist shops
- Pharma distributors and stockists
- Hospitals and clinics running in-house pharmacies

## What's included

- Premises and staffing readiness check
- Application to the State Drugs Controller
- Inspection support
- Post-licence record-keeping guidance

## Documents

- Premises ownership or rent agreement and site plan
- Pharmacist's registration certificate and appointment letter (retail)
- Competent person's qualification and experience proof (wholesale)
- Refrigerator purchase invoice
- Business registration documents

## Process

1. **Ready** — Premises, storage and staff in place.
2. **Apply** — Application and fees submitted.
3. **Inspect** — Drug inspector visit and licence grant.

## FAQs

### Can a non-pharmacist open a medical shop?

Yes, as the owner, but the retail outlet must employ a registered pharmacist who is present during business hours and supervises the sale of prescription drugs.

### Do online pharmacies need a drug licence?

Yes. Any person selling or distributing drugs needs a licence for the premises from which medicines are stored and dispatched. E-pharmacy-specific rules have been proposed but the existing licensing requirements apply in the meantime.

### Does a drug licence need to be renewed?

Licences granted under the amended rules remain valid as long as the retention fee is paid every five years and conditions are met. Lapsing the retention fee can lead to the licence being treated as cancelled.

## Official sources

- CDSCO — SUGAM portal: https://cdsco.gov.in/

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Canonical page: https://www.industax.com/services/business-licences/drug-licence
Publisher: Indus Tax — CA-led tax and compliance firm (https://www.industax.com). Contact: info@industax.com, 9059139258.
This is general information, not advice for your specific facts.