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Sat, Jan 03 2026
Raju Karn
Any business engaged in distributing medicines and pharmaceutical products must comply with strict licensing requirements under the Drugs and Cosmetics Act, 1940. One of the most commonly issued licenses for wholesalers is the Form 20B Drug License.
This blog explains what Form 20B is, who needs it, and why it is necessary for wholesale drug operations.
Form 20B is an official license that authorizes a business to sell, stock, exhibit, or distribute allopathic drugs on a wholesale basis. It is granted by the State Drug Control Department and is mandatory for any company supplying medicines to retailers, hospitals, or other wholesalers.
This license covers general drugs but does not include Schedule C and C1 drugs like vaccines and sera, which require a separate Form 21B.
You must apply for Form 20B if your business involves:
Wholesale distribution of pharmaceutical products
Supplying medicines to chemists, medical stores, or hospitals
Stocking drugs for sale to registered retailers
Operating a distribution center or warehouse for allopathic drugs
Some common examples of businesses requiring this license:
Issuing Authority: State Drug Control Department
Scope: Wholesale trade of allopathic drugs excluding Schedule C and C1 items
Premises Requirements:
Minimum area as prescribed (often 10–15 square meters)
Adequate storage facilities with refrigeration (if required)
Staff Qualifications: The business must employ:
Validity: Usually valid for 5 years, subject to renewal
Record Keeping: Mandatory maintenance of purchase and sale records as per regulations
Legal Compliance: Mandatory under the Drugs and Cosmetics Act to conduct wholesale business legally.
Supply Chain Integrity: Ensures medicines are sourced and distributed through verified channels.
Consumer Safety: Helps prevent counterfeit and substandard drugs from entering the market.
If you plan to start or operate a wholesale pharmaceutical business in India, obtaining a Form 20B Drug License is a crucial first step. It guarantees that your operations meet the legal standards set by regulatory authorities and helps you build credibility with suppliers and customers alike.