Form 20B is a license issued by the State Drug Control Department authorizing a business to wholesale allopathic drugs excluding Schedule C and C1 items.

Is Form 20B mandatory for wholesale drug business?

Yes, it is legally mandatory under the Drugs and Cosmetics Act, 1940.

Form 20B

Tue, Jul 08 2025

Shubham Bansal

What is Form 20B? – Wholesale Drug License

Q: Who needs a Form 20B License?

Pharmaceutical wholesalers, distributors, and supply chain businesses involved in selling medicines to retailers and hospitals need Form 20B.

Introduction

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.

What is Form 20B?

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.

Who Needs a Form 20B License?

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:

Pharmaceutical distributors
Wholesalers and stockists
Supply chain companies distributing medicines

Key Features of Form 20B 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:
- A registered pharmacist OR
- A competent person with minimum one year of experience in drug sales
Validity: Usually valid for 5 years, subject to renewal
Record Keeping: Mandatory maintenance of purchase and sale records as per regulations

Difference Between Form 20B and Form 21B

Aspect	Form 20B	Form 21B
Applicable Drugs	General allopathic drugs	Schedule C & C1 drugs (e.g., vaccines, injectables)
Type of Business	Wholesale distribution	Wholesale distribution of specialized drugs
Special Conditions	Standard storage requirements	Additional cold chain and safety protocols

Why is Form 20B Important?

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.

Conclusion

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.