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Wholesale Drug License — Distribute Medicines Pan-India

Pharmaceutical distributors, C&F agents and wholesale stockists must obtain a Wholesale Drug License from the State Drug Controller before supplying any drugs.

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What is Wholesale Drug License?

A Wholesale Drug License (Form 20B/21B) is issued by the State Drug Licensing Authority to authorize wholesale distribution and supply of drugs to retailers, hospitals, clinics and institutions. It is mandatory for pharmaceutical distributors, C&F agents, super-stockists and hospital pharmacies purchasing in bulk. A wholesale drug licensee cannot sell directly to patients.

Who Needs This Drug License?

Key Benefits of Getting Drug License

✓Legal authorization for bulk drug procurement and distribution
✓Enables direct tie-ups with pharmaceutical manufacturers
✓Required for GST registration under pharma distribution
✓Enables supply to government hospitals and institutions
✓Required for import of drugs under Drug Import License
✓Builds credibility with banks for working capital financing

Documents Required

Step-by-Step Process

1

Premises Setup

Ensure warehouse meets storage, temperature control and space requirements.

2

Competent Person Appointment

Appoint a qualified person (D.Pharm or B.Pharm) for supervision.

3

Application Filing

File Form 19B with the State Drug Licensing Authority.

4

Document Submission

Submit warehouse plan, cold storage specs and KYC documents.

5

Warehouse Inspection

Drug Inspector inspects storage facilities for Good Storage Practice compliance.

6

License Issued

Wholesale Drug License in Form 20B/21B issued for the registered premises.

Timeline & Turnaround

Basic
₹499 · Standard Processing
Standard
₹1,499 · Priority Processing
Premium
₹2,999 · Express + Dedicated Expert

⏱Expected timeline:15–30 working days (Standard); 10–15 working days (Premium)

Penalty for Non-Compliance

⚠️Warning:Distribution of drugs without a wholesale license attracts imprisonment up to 3 years, fine up to ₹10,000 and cancellation of business registration under the Drugs and Cosmetics Act 1940.

Simple, Transparent Pricing

All plans include expert assistance, document review, and filing support. No hidden charges.

Basic

₹499one-time
  • Document checklist guidance
  • Application form preparation
  • Single authority submission
  • Email support
  • Certificate delivery (digital)
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Standard

₹1,499one-time
  • Everything in Basic
  • Priority application filing
  • Dedicated compliance expert
  • Authority follow-up included
  • Phone + WhatsApp support
  • Physical certificate delivery
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Premium

₹2,999one-time
  • Everything in Standard
  • Express priority processing
  • Inspection representation
  • Objection & query handling
  • Annual compliance reminder
  • Free 1-year renewal reminder

Frequently Asked Questions

Can a wholesale licensee also retail drugs?+
No. Wholesale and retail licenses are separate. A wholesale licensee can supply to retailers and institutions but cannot sell directly to end consumers.
What is the storage temperature requirement?+
Drugs should be stored at 15–25°C (ambient). Vaccines and biologicals require cold chain (2–8°C). Warehouses must have validated temperature monitoring systems.
Is GST mandatory for wholesale drug distribution?+
Yes. Wholesale drug distributors with turnover above ₹40 lakhs must register for GST. Many drugs carry 5% GST, but the registration itself is mandatory.
What records must a wholesale licensee maintain?+
Wholesale licensees must maintain purchase/sale records (Form 6A), batch records, delivery challans, and submit annual returns to the Drug Licensing Authority.
Is a separate license needed for veterinary drugs?+
Yes. Separate licenses are required for human drugs and veterinary drugs under Schedule X of the Drugs and Cosmetics Rules.

Drug License in Top Indian Cities

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DelhiMumbaiBengaluruChennaiHyderabadPuneKolkataAhmedabadJaipurLucknowSuratNoidaGurgaonChandigarhKochiIndoreNagpurCoimbatoreBhopalPatnaVadodaraBhubaneswarMysuruVisakhapatnam

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