License / Approval

Drug License

Mandatory license for retail, wholesale, or manufacturing of drugs and pharmaceuticals

A Drug License is mandatory for any entity involved in the manufacture, sale, distribution, or storage of drugs and pharmaceutical products in India, governed by the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organisation (CDSCO) and State Drug Authorities issue different types of licenses. ComplyBridge provides end-to-end support for obtaining the appropriate drug license for your business.

Service Overview

Starting Price₹3,999 onwards
Govt. FeeAs applicable per state
Timeframe15–45 Working Days

Key Benefits:

Legal authority to sell, stock, and distribute drugs
Compliance with Drugs and Cosmetics Act, 1940
Avoid raids, penalties, and business closure
Mandatory for opening a pharmacy or medical store

Key Benefits of Drug License

Legal authority to sell, stock, and distribute drugs
Compliance with Drugs and Cosmetics Act, 1940
Avoid raids, penalties, and business closure
Mandatory for opening a pharmacy or medical store
Required for importing pharmaceutical products
Access to wholesale drug distribution networks
Eligibility for government pharmaceutical tenders
Consumer confidence in product safety

Documents Required

01Application Form 19 (retail) or Form 20 (wholesale)
02Proof of premises (ownership/rent deed)
03Layout plan of the premises
04Affidavit by the applicant
05Registered pharmacist certificate (for retail)
06Copy of qualification of the competent person
07List of drugs to be handled
08NOC from local authority
09PAN and Aadhar of applicant
10Refrigeration facility proof (if applicable)

Registration Process

01

License Type Identification

Determine the correct license type — retail pharmacy, wholesale, or manufacturing.

02

Premises Compliance

Ensure premises meet the required area, storage, and qualified pharmacist requirements.

03

Application Filing

Submit application forms with required documents to the State Drug Licensing Authority.

04

Premises Inspection

A drug inspector will inspect your premises for compliance with storage and safety standards.

05

License Issuance

Receive Drug License Certificate after successful inspection and verification.

06

Annual Renewal

Renew the drug license annually before expiry to maintain compliance.

Frequently Asked Questions

What types of drug licenses are there?

Main types include: Form 20 (retail sale), Form 21 (wholesale of drugs), Form 25 (manufacture of drugs other than ASU), and Form 28 (restricted allopathic drugs).

Is a registered pharmacist required?

Yes, a retail drug license requires the presence of a registered pharmacist during business hours.

What is the minimum area required for a pharmacy?

A minimum area of 10 sq. meters is required for retail drug stores; the requirement may vary by state.

Can I sell drugs online with a drug license?

Online sale of medicines requires additional compliance as per the Ministry of Health guidelines and state-specific rules.

What is the penalty for selling drugs without a license?

Selling drugs without a license is a criminal offense under the Drugs and Cosmetics Act, attracting imprisonment up to 3 years and/or a fine.

Ready to Get Your Drug License?

Our experts are ready to guide you through the entire process. Get a free consultation today.