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Thu, Jul 24 2025
Shubham Bansal
If you're planning to start a medicine distribution or wholesale drug business in India, the first legal requirement is obtaining a Wholesale Drug License. Without this license, stocking and selling pharmaceutical drugs in bulk is considered illegal under the Drugs and Cosmetics Act, 1940.
In this guide, we’ll walk you through the eligibility criteria, required documents, step-by-step process, fees, and compliance tips for obtaining a Wholesale Drug License in India (2025 edition).
A Wholesale Drug License allows a business to buy, stock, sell, and distribute drugs or medicines in bulk—usually to retailers, hospitals, clinics, and other wholesalers.
It is issued by the State Drug Control Department or, in some cases, by the Central Drugs Standard Control Organization (CDSCO) for specific categories (e.g., imported or restricted drugs).
You need a Wholesale Drug License if your business involves:
Distributing medicines to pharmacies or hospitals
Supplying drugs to clinics, practitioners, or medical institutions
Importing or exporting pharmaceutical products
Supplying controlled substances or Schedule H/H1 drugs
Selling drugs to government departments or tender contracts
To apply for a wholesale drug license, you must meet the following criteria:
To qualify, your business must have a minimum 15 sq. meter premises with adequate ventilation, storage, and refrigeration setup for storing temperature-sensitive medicines.
The business entity must be legally registered — acceptable formats include Proprietorship, Partnership, LLP, Pvt. Ltd., or OPC.
You must appoint a Competent Person with either:
Graduation + 1 year pharma experience, or
SSC + 4 years pharma experience
Your premises must have a GST registration and Shop & Establishment license, as per your state’s regulations.
Proper cold storage and air-conditioned conditions must be maintained, including a functional refrigerator for heat-sensitive medicines.
Here’s a complete checklist of documents you’ll need to apply:
Business registration certificate (Partnership Deed / Company Incorporation)
Follow these steps to apply for the license without delay:
Gather and verify all required documents, especially premises-related and pharmacist/competent person details.
Each state has a dedicated website for drug license applications. Some states still accept physical applications.
Fill Form 19 for wholesale license. Upload documents and pay government fee.
The Drug Inspector visits your premises to check infrastructure, storage, and document authenticity.
If inspection is successful and documents are in order, license is issued in 30–60 working days.
The government fee for obtaining a Wholesale Drug License under Form 20B/21B generally ranges between ₹3,000 to ₹6,000, depending on your state or union territory's drug control department.
In addition to the base fee, applicants may be required to pay inspection fees or miscellaneous state-imposed charges, usually between ₹1,000 to ₹2,000.
If you hire a professional or consultant for assistance with your application, additional charges will apply. These are not fixed and depend on the complexity of the application and support needed.
Note: Professional/consultancy fees are charged separately if you take expert assistance.
Avoid these errors to prevent delays or rejection:
Missing or incorrect documents
Inadequate premises or lack of refrigeration
Unqualified or part-time competent person
Wrong application form or authority
Failure to comply with state-specific rules
Pro Tip: Let compliance experts handle document verification and submission for error-free approval.
At PSR Compliance, we make the drug license registration process:
Faster with proper documentation
Simpler with expert guidance and coordination
Error-Free through state-specific regulatory expertise
Reliable with end-to-end support until you get your license
Need help? Talk to our Drug License Experts
Need help with your application? Let our team handle it from start to finish — so you can focus on growing your business.
👉 Contact PSR Compliance Now