Company Registration
NGO Registration
Virtual business address
Startup Registration
Shop Act Registration
BIS Registration main
CDSCO Registration
Star Rating Certification
WPC Registration
Brand Registration
Legal Metrology Certification
CPCB Approval
PESO certification
Fire NOC
AERB Certification
PSARA License
Fssai License
RCMC Certification
Import Export Registration
China Food Export
RNI Certification
NSIC Registration
ISO Certification Main
ICEGATE Registration Main
Income tax Filing
Annual Compliance
Trade License Registration
Factory License Registration
Tue, Dec 30 2025
Raju Karn
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 (2026 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 Documents
Business registration certificate (Partnership Deed / Company Incorporation)- GST registration certificate- PAN card of the firm- Cancelled cheque or bank account proof- Shop Act License (if applicable)Premises & Infrastructure
- Rent agreement or ownership deed of premises- Blueprint/layout of the premises (min. 15 sq. meters)- Refrigerator invoice for cold chain drugs- Electricity bill or NOC
Personal & Qualification Documents
- Identity and address proof of owner/partners/directors- Qualification and experience certificate of the competent person- Appointment letter and undertaking of the competent person- Affidavit of full-time engagement.
Getting a Wholesale Drug License in India is a step-by-step legal process. If you follow each step carefully and keep your documents ready, the process becomes smooth and faster.
First, you need to collect and check all your documents properly. This step is very important because most delays happen due to missing or incorrect papers.
You will need documents related to:
Make sure everything is updated and matches correctly.
Every state in India has its own Drug Control Department website where you must apply online.
You need to:
Some states may still accept offline applications, but most of the process is now online in 2026.
After registration, you need to fill the official application form for a wholesale license (usually Form 19 or as per state rules).
In this step:
Once submitted, your application goes for review.
After document verification, a Drug Inspector will visit your business location.
During inspection, they check:
This step is very important because approval depends on inspection results.
If everything is correct and the inspection is successful, your application gets approved.
After approval:
Once you get the license, you can legally start wholesale drug business operations in India.
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.
Inspection and Miscellaneous Charges
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.
Consultancy or Professional Fees (If Applicable)
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
Q1. Can I apply for a wholesale drug license online?- Yes, most states now offer online portals. However, inspection is still done offline.
Q2. What is the validity of a wholesale drug license in India?- It is valid for 5 years and must be renewed before expiry.
Q3. Can a doctor apply for a wholesale drug license?- Yes, if they meet eligibility criteria and have a valid business setup.
Q4. Can I sell drugs directly to consumers with a wholesale license?- No, wholesale license only permits supply to licensed entities, not end-consumers.
Q5. Is a pharmacist required for wholesale drug license?- No, but you need a competent person with required qualifications/experience.### Q1. Can I apply for a wholesale drug license online?