Drug licence for a medical store: forms, documents and inspection

Who issues it

Licences to sell medicines are issued by the State Licensing Authority — the state’s Drugs Control Department — under the Drugs and Cosmetics Act, 1940 and its Rules of 1945. Many states take applications online.

Which licence

The application is made in Form 19. For retail sale, a medical store usually holds two licences:

• Form 20 — medicines other than those in Schedules C, C1 and X
• Form 21 — medicines in Schedules C and C1, such as vaccines and insulin
• Schedule X medicines need a separate licence
• Wholesale has its own licences (Forms 20B and 21B)

What is usually asked for

Each state publishes its own checklist. It commonly includes:

• The application and the fee paid
• Proof of the premises — ownership papers or a rent agreement — and a plan with the area
• The pharmacist’s registration certificate and appointment
• Identity and address proof of the owner, partners or directors
• Partnership deed or company papers, if any
• Details of the refrigerator and storage

The inspection

Before the licence is granted, a drug inspector visits to check the premises, the storage and the pharmacist. Keep the shop ready as it will run: racks, refrigerator and the pharmacist present.

After you have it

Display the licence in the shop. Keep purchase and sale records, sell prescription medicines only against a prescription, and keep the Schedule H1 register. Tell the authority about changes such as a new pharmacist or new premises.

Keeping it valid

Since an amendment to the Rules in 2017, a sale licence no longer needs renewal every five years; it stays valid while a retention fee is paid every five years. Paying late adds a penalty — check your state’s current fee and dates.