Drug Licence

Retail, wholesale, or manufacturing drug licence from the State Drug Controller

Validity: 5 years (manufacturing); 1–5 years (retail/wholesale)

What is Drug Licence?

A Drug Licence is mandatory for any entity that sells, stocks, distributes, or manufactures drugs in India. We apply for retail drug licence, wholesale drug licence, or drug manufacturing licence and handle all State Drug Controller requirements.

Drug licences in India are regulated under the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945. The licences are of three main types: Retail Drug Licence (for pharmacies and chemist shops), Wholesale Drug Licence (for pharmaceutical distributors and C&F agents), and Drug Manufacturing Licence (for manufacturers). Retail and wholesale licences are issued by the State Drug Licensing Authority; manufacturing licences are issued by the State Licensing Authority for manufacturing. The application is filed with the State Drug Controller's office and requires a qualified pharmacist (for retail), a technically qualified person, and premises that meet the prescribed area, storage, and hygiene requirements. Drug licences must be renewed periodically (typically every 5 years for manufacturing, every 1 year for retail/wholesale). A separate NOC is required to include narcotic and psychotropic substances in the product list.

Who Needs Drug Licence?

Pharmacy owners, medical store operators (retail drug licence), pharmaceutical distributors and stockists (wholesale), pharmaceutical manufacturers (manufacturing drug licence), and hospital pharmacies.

What's Included

Retail, Wholesale, or Manufacturing Drug Licence issued by the State Drug Controller
Qualified Pharmacist or technically qualified person compliance confirmed
Premises requirements (area, storage, refrigeration) confirmed
Product list approved under the licence
Narcotic/psychotropic NOC obtained where applicable

⚠️ Penalty for Non-Compliance

Selling, stocking, or manufacturing drugs without a valid drug licence is an offence under the Drugs and Cosmetics Act, 1940, attracting imprisonment of up to 3 years and/or fines. Adulterated or misbranded drug sale can lead to much higher penalties including imprisonment of up to 10 years.

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How It Works

1
Premises assessment
Premises are checked for minimum area, storage, temperature control, and other requirements specific to retail, wholesale, or manufacturing.
2
Application preparation
All documents compiled and the application prepared for the State Drug Control office.
3
Inspection
The Drug Inspector inspects the premises and verifies compliance with the Drugs Rules.
4
Licence grant
On satisfactory inspection, the Drug Licence is issued by the State Licensing Authority.

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Documents Required

Items marked Required are mandatory; others are situational.

Premises

Proof of possession (lease/ownership)Required
Premises layout planRequired
Cold storage/refrigeration details

Personnel

Pharmacist qualification certificate and Council registrationRequired
Pharmacist appointment letterRequired

Business

Business registration documentsRequired
PAN of proprietor/firm/companyRequired

Fees & Pricing

Fees

State Drug Controller government fee

Varies by state, licence type, and number of drugs — check State Drug Controller website

Varies

Professional fee

Quoted after confirming the licence type and state

Varies

* Government fees may vary. GST applicable on professional fees. Final pricing confirmed after review.

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Frequently Asked Questions

What qualifications are required to obtain a Retail Drug Licence?

A B.Pharm or D.Pharm (Diploma in Pharmacy) registered pharmacist must be employed full-time at the pharmacy. The pharmacist's registration certificate from the State Pharmacy Council is required.

What is the minimum area required for a retail pharmacy?

The Drugs Rules prescribe a minimum of 10 square metres for a retail pharmacy. Many states prescribe higher minimums. The Drug Inspector confirms compliance during the inspection.

Can a drug licence cover multiple locations?

No. Each pharmacy, warehouse, or manufacturing unit requires a separate drug licence.

Is a separate licence needed for Schedule H/H1 and narcotic drugs?

Schedule H and H1 drugs are covered by the retail/wholesale licence. A separate NOC from the Narcotics Commissioner is required to stock and sell narcotic and psychotropic substances.

What is the renewal process for a drug licence?

Retail/wholesale licences are renewed annually or every 5 years depending on the state. Manufacturing licences are renewed every 5 years. Late renewal attracts penalties.

Can a drug licence be transferred if the business is sold?

Drug licences are premises-specific and person-specific. On change of ownership, a fresh drug licence application is required. The existing licence cannot be transferred.