How to Get a Wholesale Drug License in India

The pharmaceutical sector in India is witnessing rapid growth, with an increasing demand for medicines across retail and wholesale markets. To ensure the safety, quality, and legality of medicines, the Government of India has made it mandatory for businesses involved in manufacturing, distributing, or selling drugs to obtain a Drug License under the Drugs and Cosmetics Act, 1940.

For wholesalers, obtaining a Wholesale Drug License is a critical step before starting operations. At ZYPS Regulatory Consultancy, we assist businesses in navigating this process smoothly and compliantly.

The licensing process is governed under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. For wholesale distribution, applicants must acquire:

• Form 20B and Form 21B – For wholesale of allopathic drugs
• Form 20G – For wholesale of Schedule X drugs
• Form 20C – For ayurvedic and other traditional medicines

The application typically takes about 30 days for approval, depending on the Drug Inspector’s report and the decision of the State Licensing Authority.

Why Do You Need a Wholesale Drug License?

• Legal authorization to manufacture, store, and distribute drugs
• Builds trust and credibility in the pharmaceutical supply chain
• Ensures compliance with regulatory frameworks
• Protects businesses from penalties, product seizures, and reputation loss

Eligibility Criteria for Applying

Applicants must fulfil certain requirements to obtain a Wholesale Drug License:

• Minimum premises area of 15 square meters
• Refrigerator and air conditioning for proper storage of drugs
• A registered pharmacist or a competent person to supervise operations
• Applicant must hold a degree/diploma in pharmacy with at least 1 year of experience, or be an SSLC holder with 4 years’ experience in drug handling
• Any entity such as a proprietorship, partnership, LLP, or company can apply

 Required Documents

To apply for a Wholesale Drug License in India, the following documents are generally required:

• Filled Form 19 application
• Challan fee (₹3,000)
• Affidavit of proprietor and registered pharmacist
• Educational certificates (self-attested) of proprietor and pharmacist
• Identity proofs (Domicile/Driving License/Voter ID)
• Premises documents – Ownership proof / Rent agreement / Tax receipt
• Blueprint of premises layout
• Refrigerator purchase bill
• Passport-sized photographs of proprietor and pharmacist
• All documents scanned in PDF (Gray scale)

Drug License Application Procedure

How to Obtain a Wholesale Drug License in India

1. Visit the state-specific drug licensing portal (For Delhi: xlnindia.gov.in)
2. Register and create a user account
3. Fill in the online application form with business and pharmacist details
4. Upload photographs, certificates, and required documents
5. Generate and sign the self-declaration form (Proprietor + Pharmacist)
6. Upload completed Form 19/19A/19B/19C (as applicable)
7. Make fee payment via FRAS and upload challan copy
8. Submit the completed application online
9. Drug Inspector reviews the application and inspects premises if required
10. Upon approval, the license is issued in Form 20B/21B/20C
11. The printed license must be displayed at the wholesale premises

 Validity of Wholesale Drug License

The license is granted perpetually unless suspended or cancelled by the Licensing Authority. However, businesses must pay a retainer fee every five years to maintain validity.

Conclusion

A Wholesale Drug License is essential for operating legally in India’s pharmaceutical market. The process, though systematic, requires strict compliance with regulatory requirements and accurate documentation.

At ZYPS Regulatory Consultancy, we specialize in assisting businesses with end-to-end support for obtaining Wholesale Drug Licenses, ensuring faster approvals and full compliance with the Drugs and Cosmetics Act.