What documents are required for Form 20B and 21B?

Documents include pharmacist qualification, address proof, warehouse details, drug list, and compliance certificates.

How long does it take to get a drug license in India?

Generally, the license is issued within 30–45 days after inspection and verification by the drug inspector.

Drug Licence Form 20B & 21B

Fri, May 30 2025

Shubham Bansal

Drug License Form 20B & 21B in India – Retail vs Wholesale Guide (2025)

Q: What is Form 20B drug license?

Form 20B is a retail drug license required by pharmacies and medical stores to sell medicines directly to consumers.

Q: What is Form 21B drug license?

Form 21B is a wholesale drug license for distributors who supply drugs to retailers, hospitals, and clinics.

Introduction to Drug Licence Form 20B & 21B

If you are in the pharmaceutical business in India, obtaining the correct drug licence is mandatory. Two critical forms for drug retail and wholesale licensing are Form 20B (Retail Drug Licence) and Form 21B (Wholesale Drug Licence). The Drugs and Cosmetics Act of 1940 grants these licenses. This ensures that businesses follow safety and quality standards.

This blog explains the main differences between Form 20B and Form 21B drug licenses. It covers eligibility, the application process, and the documents needed. Whether you are a pharmacist, distributor, or pharmacy owner, this guide will help you navigate the licensing process smoothly.

What is Form 20B Drug License?

Businesses involved in the retail sale of drugs require the Form 20B drug license. It applies to:

Retail pharmacies
Medical stores
Online pharmacies (if selling medicines directly to consumers)

Key Features of Form 20B

✔ Retail-Specific – Only for selling drugs directly to consumers.

✔ Mandatory for Pharmacies – Without this, running a medical store is illegal.

✔ State-Level Approval – Issued by the State Drugs Control Department.

What is Form 21B Drug License?

The Form 21B licence is necessary for businesses engaged in the wholesale distribution of drugs. This includes:

Wholesale drug suppliers
Distributors supplying to pharmacies & hospitals
Medical equipment suppliers dealing in medicines

Key Features of Form 21B

✔ Wholesale Distribution – Allows bulk selling to retailers, hospitals, and clinics.

✔ Stricter Storage Norms – Requires proper warehousing conditions.

✔ State or Central Approval – Depending on the drug category (Schedule X drugs need central approval).

Key Differences Between Form 20B & 21B

Aspect	Form 20B (Retail Licence)	Form 21B (Wholesale Licence)
Purpose	Retail sale to consumers	Wholesale distribution
Applicability	Pharmacies & medical stores	Distributors & suppliers
Approval Authority	State Drug Control Dept.	State/Central Drugs Authority
Storage Requirements	Basic pharmacy standards	Strict warehouse compliance
Inspection Process	Mandatory before approval	More rigorous checks

Eligibility Criteria for Form 20B & 21B

For Form 20B (Retail Licence)

Qualified Pharmacist – A registered pharmacist must be present.
Minimum Space Requirement – As per state regulations (usually 10-15 sq. meters).
Proper Storage Facilities – Temperature-controlled storage for medicines.

For Form 21B (Wholesale Licence)

Competent Technical Staff – At least one employee with a pharmacy degree.
Adequate Warehouse Space – Must comply with drug storage guidelines.
Documentation of Suppliers & Buyers – Proper records of drug procurement & distribution.

Documents Required for Drug Licence Form 20B & 21B

Common Documents for Both Licences

Proof of business ownership (Rent agreement/Property papers)
ID & Address Proof of applicant (Aadhaar, PAN, etc.)
Qualification certificates (Degree/Diploma in Pharmacy)
Affidavit of non-conviction under the Drugs & Cosmetics Act

Additional for Form 21B (Wholesale)

List of drugs to be traded
Warehouse compliance certificate
Details of storage facilities (Cold storage if required)

Step-by-Step Application Process

1. Online Registration

Visit the state drug control department’s portal.
Register as a new applicant.

2. Fill Application Form

Select Form 20B (Retail) or Form 21B (Wholesale).
Enter business details, pharmacist qualifications, and storage information.

3. Upload Documents

Submit scanned copies of all required documents.

4. Fee Payment

Pay the applicable licence fee (varies by state).

5. Inspection & Approval

A drug inspector will verify the premises.
If compliant, the licence is issued within 30-45 days.

Common Reasons for Drug Licence Rejection

❌ Incomplete documentation ❌ Non-compliance with storage norms ❌ Lack of qualified pharmacist (for Form 20B) ❌ Failure in inspection (poor facility conditions)

To avoid delays, ensure all requirements are met before applying.

Conclusion: Ensure Compliance with Expert Guidance

Obtaining a drug licence Form 20B or 21B is crucial for legally operating a pharmacy or wholesale drug business. The process involves strict compliance with Drugs and Cosmetics Act regulations, proper documentation, and facility inspections.

If you need help with your Form 20B or Form 21B drug license, a PSR compliance consultant can make things easier. They can help you get quick approvals and ensure you meet all requirements. Stay legally compliant and grow your pharmaceutical business with the right licensing support!