FDA Drug License Verification Portal – How to Use It Effectively

In the pharmaceutical and healthcare industry, ensuring that a distributor holds a valid drug license is critical for safety, trust, and compliance. With increasing regulations and risks of counterfeit drugs, verifying a wholesale drug license issued by the Food and Drug Administration (FDA) has become essential. Thankfully, India’s drug regulatory bodies have launched online portals that allow easy verification of FDA drug licenses.

Jul 30, 2025 - 10:28
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FDA Drug License Verification Portal – How to Use It Effectively

FDA Drug License in India Overview

An FDA Drug License is issued under the Drugs and Cosmetics Act, 1940, and is mandatory for individuals or companies involved in the manufacturing, storage, wholesale, or retail sale of pharmaceuticals and drugs.

There are mostly two categories:

  • Retail Drug License (RDL) – for pharmacies or chemists

  • Wholesale Drug License (WDL) – for distributors, wholesalers, and stockists

FDA Wholesale Drug License Verification: Why Do It?

  • Ensure legal compliance with the Drug Control Department

  • Avoid counterfeit or substandard products

  • Build trust with verified suppliers

  • Required during FDA audits or inspections

  • Critical for exporters/importers dealing with regulated medicines

How to Verify an FDA Drug License Online

Licenses may be checked on the FDA site maintained by the State Drug Control Department in each Indian state. Certain states, such as Tamil Nadu, Gujarat, and Maharashtra, offer sophisticated sites for convenient access.

Procedure for Verifying an FDA License Online:

  1. Visit the State FDA Website
    Example: Maharashtra – https://fdawizard.maharashtra.gov.in

  2. Navigate to ‘License Verification’ or ‘Know Your License’ section

  3. Enter Key Details:

    • License Number

    • Name of the license holder

    • Firm name or district

  4. Submit & View Results
    The system will show details like license type, validity, address, and current status.

If you cannot find the information online, you may contact the local Drug Control Officer (DCO) or FDA helpdesk.

FDA License Cost in India

The location, business size, and kind of license all affect the cost of an FDA license in India.

License Type FDA License India Fees (Approx.)
Retail Drug License (RDL) ₹3,000 – ₹6,000
Wholesale Drug License (WDL) ₹5,000 – ₹10,000
Renewal Charges ₹3,000 – ₹5,000
Modification / Duplicate ₹500 – ₹1,000

Required Documents for FDA Wholesale Drug Licences

  • Application in Form 19

  • Premises Ownership/Rental Proof

  • Pharmacist's Qualification Certificate

  • Affidavit regarding non-conviction

  • Site Plan/Layout

  • Partnership deed or company incorporation certificate

  • Cold storage proof (if applicable)

Final Thought

By using the FDA Drug License Verification Portal, you may be sure that the pharmaceutical distributors you deal with are compliant and certified. It assists in stopping fraudulent activity and guarantees that only pharmaceuticals with a quality guarantee make it to final consumers. You may protect your company from legal issues and harm to your brand by being aware of the FDA license cost in India, the process, and the verification process.

Also Checkout: 

CDSCO Online Registration

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