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Drug licence

Selling, stocking or distributing medicines — retail or wholesale — needs a drug licence from the state licensing authority. A retail chemist must work under a registered pharmacist; a wholesaler under a registered pharmacist or an experienced competent person.

Issued by
State drug controller
Law
Drugs and Cosmetics Act 1940 and the Drugs Rules 1945
Where to apply
Your state drug controller's portal, or the CDSCO online national drugs licensing system (ONDLS)

TaxClue does not handle this service. It is on the checklist because many of our clients need it. Raise a request and we will try to connect you with someone who can do it, where possible.

How Drug licence works

The usual picture. Procedures, fees and forms differ by state and authority — always check the current rules before you apply.

Who needs it

  • Retail pharmacies and chemist shops
  • Wholesalers, stockists and distributors of medicines
  • Hospitals and clinics that run their own pharmacy
  • Online pharmacies, for the premises they dispense from

Documents usually asked for

  • Proof of the premises, with the minimum area the rules require
  • Registration and appointment letter of the pharmacist or competent person
  • Layout of the premises and details of refrigeration for cold-chain drugs
  • Constitution of the firm and identity proof of the proprietor, partners or directors

The process

  1. Set up the premises to the area and storage rules
  2. Apply online to the state drug controller (Form 19 for a sale licence)
  3. Inspection by the drug inspector
  4. Licence granted; display it at the premises and keep sale records

What we can do today

The other registrations the same businesses need — these we handle end to end.

Full checklists that include it

Every registration for these industries, in order.