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A Drug Wholesale License is a mandatory authorization for any business engaged in the bulk purchase and sale of pharmaceutical drugs, medicines, and cosmetics to retailers, hospitals, clinics, and other institutions. Unlike a retail license, a wholesale license permits trading in larger quantities and typically does not require the applicant to sell directly to individual patients over the counter.
Under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, a wholesale drug license is issued in Form 20-B (for drugs other than those specified under Schedule X) or Form 21-B (for drugs specified in Schedule X). Businesses distributing medicines across the supply chain — from manufacturer to retailer — must hold this license before commencing operations at each place of business.
Depending on the category of drugs your business deals in, different types of wholesale license apply.
Wholesale license for the sale of drugs other than those specified under Schedule X.
Wholesale license for the sale of drugs specified under Schedule X, which are subject to stricter controls.
Required for businesses engaged in the bulk trading and distribution of cosmetic products.
Issued for restricted or general wholesale trading of pharmaceutical formulations depending on state rules.
A drug wholesale license is required for any business that trades in bulk quantities of drugs, medicines, or cosmetics.
To be eligible for a drug wholesale license, the applicant must meet the following criteria:
The following documents are required for a drug wholesale license application:
The following is a concise description of the procedure for obtaining a drug wholesale license.
Get in touch with our experts to discuss your wholesale drug trading requirements and business plan.
Register on the drug licensing portal. After registration, login information is sent to the registered email address or mobile number.
Update the information on the qualified pharmacist or competent person on the portal.
Submit all requisite details and upload necessary documents. The application is submitted with required payments.
A drug inspector visits the location to authenticate the premises and check the originality of documents. The inspection report is submitted to DLA.
Based on the inspection report, the final wholesale license is issued by the Drug Licensing Authority.
The drug wholesale license is valid indefinitely, subject to compliance with periodic inspections and regulatory requirements. To maintain the license, businesses must:
We manage every step, document, and follow-up with the Drug Licensing Authority so you can focus on your wholesale trading business.
We verify your eligibility and ensure all required documents are complete and valid.
Complete wholesale license application drafting and verification to ensure error-free submission.
Assistance in verifying pharmacist or competent person qualifications and registrations.
Guidance on preparing premises and storage facilities for drug inspector visits.
Complete application filing through the drug licensing portal.
We respond to all queries from the Drug Licensing Authority on your behalf.
Regular follow-up with DLA to ensure timely processing of your application.
Assistance with post-license compliance, renewals, and regulatory updates.
Help with preparing and organizing all required documents for the application.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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