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Mon, Dec 29 2025
Raju Karn
If you are planning to start a pharmacy or work as a distributor in the pharmaceutical sector, getting the right drug license is not optional—it is a legal requirement. Under the Drugs and Cosmetics Act, 1940, businesses must obtain specific licenses to ensure that medicines are sold, stored, and distributed safely.In India, the key drug licenses are:
- Form 20 & 21 → For retail businesses such as pharmacies and medical stores.
- Form 20B & 21B → For wholesale businesses that supply medicines in bulk to hospitals, clinics, and retailers.
This article explains the difference between retail and wholesale drug licenses, their eligibility criteria, required documents, and the step-by-step application process. Whether you are a pharmacist, retailer, or distributor, this guide will help you understand which license you need.
A retail drug license is required when medicines are sold directly to consumers. This applies to:
- Pharmacies and chemist shops- Medical stores- Online pharmacies delivering to patients
✔ Form 20 → Retail sale of general allopathic drugs (non-Schedule C, C1, or X).
✔ Form 21 → Retail sale of Schedule C & C1 drugs (e.g., vaccines, insulin).- Retail Use Only – Meant for businesses selling drugs directly to the public.- Mandatory for Pharmacies – Operating without this license is illegal.- Issued by State Authority – Approved by the State Drugs Control Department.
A wholesale drug license is mandatory for businesses involved in large-scale distribution of medicines. This applies to:
- Wholesale suppliers- Distributors serving pharmacies, hospitals, or clinics- Stockists supplying medicines in bulk
✔ Form 20B → Wholesale sale of general allopathic drugs (non-Schedule C, C1, or X).
✔ Form 21B → Wholesale sale of Schedule C & C1 drugs (special storage needed).- Wholesale Distribution – Allows bulk supply to retailers and healthcare institutions.- Stricter Storage Rules – Proper warehouses and cold storage may be required.- State/Central Approval – In some cases, central approval is needed for restricted drugs (e.g., Schedule X).
- A registered pharmacist must be present.
- Minimum shop space (usually 10–15 sq. meters, depending on state).
- Proper storage conditions for medicines.
- Competent staff with a pharmacy degree or relevant qualification.- Adequate warehouse/storage facility with temperature control.- Proper documentation of suppliers and buyers.
- Proof of business premises (Rent agreement/Property papers)- Identity & Address proof (PAN, Aadhaar, etc.)- Qualification certificates (Pharmacy degree/diploma)- Affidavit of non-conviction under the Drugs & Cosmetics Act
- List of medicines to be supplied- Warehouse compliance certificate- Details of storage facilities (e.g., cold storage units)
1. Online Registration – Visit the respective state drug control authority’s portal and create a new account.
2. Fill the Application Form – Select the appropriate license (Form 20/21 for retail, Form 20B/21B for wholesale).
3. Upload Documents – Submit scanned copies of all required documents.
4. Fee Payment – Pay the license fee (amount varies by state).
5. Inspection & Approval – A drug inspector visits the premises; if compliant, the license is issued within 30–45 days
❌ Missing or incomplete documents
❌ Lack of qualified pharmacist or technical staff
❌ Poor storage arrangements (no cold storage where required)
❌ Premises failing inspection standards
👉 To avoid delays, make sure all requirements are met before applying.
Getting the right drug license—whether retail (20 & 21) or wholesale (20B & 21B)—is essential to legally run a pharmacy or distribution business in India. The process involves proper documentation, facility inspections, and compliance with the Drugs and Cosmetics Act, 1940.
If you need assistance, a PSR Compliance consultant can guide you through the application, help prepare documents, and ensure faster approvals. With expert support, you can stay compliant and focus on growing your pharmaceutical business.