Pharma

Drug Licence

Retail, wholesale and manufacturing drug licences under the Drugs & Cosmetics Act

Get Started← All Government Licences

Overview

The Drugs & Cosmetics Act, 1940 requires every entity involved in the manufacture, sale, stocking or distribution of drugs — including allopathic, veterinary, Ayurvedic and cosmetic drugs — to hold a valid drug licence from the State Drug Licensing Authority (SDLA). Estabizz provides complete drug licence assistance: from eligibility and premises set-up to application filing, inspection preparation and post-licence compliance.

What We Offer

✓Retail drug licence (Form 20 & 21) for pharmacies
✓Wholesale drug licence (Form 20B & 21B) for distributors
✓Manufacturing licence (Form 25 & 28) — Schedule M GMP compliance
✓Loan licence and repacking licence applications
✓Registered Pharmacist and Competent Person qualification advisory
✓State Drug Authority inspection readiness support
✓Licence renewal, amendment and additional product endorsement

How It Works

1

Category Determination

Identify the correct licence form: retail (20/21), wholesale (20B/21B), or manufacturing (25/28/28-B).

2

Premises & Personnel Check

Verify premises dimensions, refrigeration, storage requirements, and qualified personnel (Registered Pharmacist for retail).

3

Application Filing

Submit application to the State Drug Licensing Authority with prescribed fees and supporting documents.

4

Inspection & Licence

Coordinate with the Drug Inspector for premises inspection; respond to queries and obtain the licence.

Documents Required

  • Premises proof (ownership/rent agreement) with area measurement
  • Registered Pharmacist / Qualified Person certificate and registration
  • Constitution documents (CoI, PAN, GST)
  • List of drugs/products to be sold or manufactured
  • Refrigeration and cold chain infrastructure details (Schedule H/X drugs)
  • Site layout plan with storage area demarcation
  • Pollution NOC (for manufacturing licence)

Frequently Asked Questions

Is a Registered Pharmacist mandatory for a retail drug store?+

Yes. A retail drug licence requires a qualified Registered Pharmacist to be in charge of the premises during working hours.

What is Schedule H and Schedule X?+

Schedule H drugs are prescription-only medications. Schedule X covers habit-forming drugs requiring additional licence conditions and record-keeping.

Can one entity hold both retail and wholesale drug licences?+

Yes, provided separate premises or clearly demarcated areas are maintained as per State Drug Authority rules.

Drug Licence — Start Today

Retail, wholesale and manufacturing drug licences under the Drugs & Cosmetics Act

Book a Free Consultation →