Anyone who sells, stocks, distributes or manufactures drugs in India needs a licence under the Drugs and Cosmetics Act, 1940 and Rules, 1945, issued by the State Drugs Control Department. Retail and wholesale licences need suitable premises, proper storage and a registered pharmacist or competent person. Manufacturing licences need approved facilities and technical staff.
Types of drug licence
| Licence | For |
|---|---|
| Retail (chemist) | Selling to consumers, run by a registered pharmacist |
| Wholesale | Selling to retailers, hospitals and other wholesalers |
| Manufacturing | Producing allopathic, cosmetic or other drugs |
| Import (CDSCO) | Importing drugs, handled centrally |
Eligibility requirements
- Premises of the minimum area prescribed, commonly about 10 square metres for retail or wholesale and more for combined licences
- Refrigerator and air conditioning for drugs needing controlled storage
- Retail: a registered pharmacist present during working hours
- Wholesale: a competent person meeting education and experience criteria
Application process
- Apply online on the state drug licensing portal or the online national drug licensing system used by the state.
- Upload premises, ownership, staff and constitution documents.
- Pay the fee.
- Inspection of the premises by a Drugs Inspector.
- Grant of licence on satisfactory inspection.
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Get expert help →Validity and compliance
Licences under the current rules generally remain valid subject to payment of a retention fee at the prescribed interval. Maintain purchase and sale records, prescription records for scheduled drugs, and display the licence at the premises.
Frequently asked questions
Can I open a medical store without being a pharmacist?
Yes, the owner need not be a pharmacist, but the retail licence requires a registered pharmacist to be employed and present during business hours to dispense medicines.
Do online pharmacies need a drug licence?
Online sellers of drugs operate through licensed retail or wholesale premises. Specific e-pharmacy rules have been proposed; in the meantime, licensing of the underlying premises and compliance with prescription rules are essential.
Is a separate licence needed for each shop?
Yes. Each premises where drugs are sold or stored needs its own licence.
Does a drug licence need renewal?
Under the current rules licences are generally retained by paying a retention fee at the prescribed interval rather than full renewal, but state practices vary. Missing the retention fee can lead to the licence lapsing.
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