- Law
- Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
- Application
- Form 19 (or 19C as applicable) to the State Drugs Control authority
- Licences
- Retail: Forms 20 and 21; wholesale: Forms 20B and 21B
- Minimum area
- 10 sq m for retail or wholesale; 15 sq m for both together
- Staff
- A registered pharmacist for retail dispensing
Which licence you need
| Activity | Licence form |
|---|---|
| Retail sale of drugs other than those in Schedules C, C(1) and X | Form 20 |
| Retail sale of drugs in Schedules C and C(1) | Form 21 |
| Wholesale of drugs other than Schedules C, C(1) and X | Form 20B |
| Wholesale of Schedules C and C(1) drugs | Form 21B |
Schedule X drugs and narcotic and psychotropic substances need additional permissions, and narcotics are also governed by the NDPS Act. Applications are made in Form 19 (or 19C as applicable) to your State Drugs Control authority, usually online.
Premises and people
- Area: at least 10 sq m for retail or wholesale, 15 sq m for both together, in a premises that meets local building rules
- Storage: refrigerators for cold-chain products with temperature logs, protection from sunlight and moisture, separate area for expired and recalled stock
- Registered pharmacist: named in the application with qualifications and state pharmacy council registration
- Records: purchase and sale records, prescription records for scheduled drugs, narcotics registers where applicable
What NABH adds on top
NABH's medication management chapter asks for more than the licence: a hospital formulary, segregation of high-alert and look-alike sound-alike medicines, cold-chain monitoring, expiry checks, narcotics control and medication-error reporting. We set up both — the licence and the system NABH checks.
Frequently asked questions
Which drug licence does a hospital pharmacy need?
Most hospital pharmacies need retail drug licences in Forms 20 and 21, applied for using Form 19 with the State Drugs Control authority. If the pharmacy also supplies other institutions, wholesale licences in Forms 20B and 21B may be needed.
What is the minimum area for a pharmacy drug licence?
State drugs control departments require at least 10 square metres for a retail or a wholesale licence and at least 15 square metres where retail and wholesale licences are held together, along with proper storage including refrigeration where needed.
Can a doctor run the hospital pharmacy without a pharmacist?
A retail pharmacy licence requires a registered pharmacist to be named and to supervise dispensing. Doctors may supply medicines to their own patients under specific conditions, but a hospital pharmacy selling medicines needs a registered pharmacist.
Official sources
Fees and rules change. Always confirm on the official page before you apply.
Get a free gap assessment for your facility
Tell us your facility type, bed or chair count and city. Dr. Ashutosh Sharma will tell you which NABH programme fits, what it will cost and how long it will realistically take — before you commit to anything.
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