Starting a business in the pharmaceutical sector requires strict compliance with regulatory laws, and one of the most essential licenses is the Drug License. Whether you’re running a retail pharmacy, wholesale drug business, or a manufacturing unit, obtaining a valid license under the Drugs and Cosmetics Act, 1940 is mandatory.
Here’s a simple step-by-step guide to get your Drug License in India in 2025:
Step 1: Determine the Type of Drug License
There are multiple categories:
Retail Drug License (for pharmacies)
Wholesale Drug License (for distributors)
Manufacturing Drug License (for manufacturers)
Step 2: Fulfill Basic Requirements
The premises must comply with location and area standards (usually 10–15 sq. meters).
The applicant must employ a registered pharmacist (for retail) or a competent person (for wholesale).
Adequate storage facilities (like refrigerators for cold-chain drugs) are required.
Step 3: Documentation
Prepare key documents including:
Identity and address proof
Proof of premises ownership/rent agreement
Qualification and experience certificates of responsible personnel
Affidavit and declaration forms
Step 4: Online Application
Submit your application through your state’s Drugs Control Department portal. Attach all documents, pay the fees, and schedule an inspection.
Step 5: Site Inspection and Approval
A Drug Inspector will visit your premises to ensure compliance. Once approved, the license is usually issued within 30–45 days.
Final Tip:
Operating without a valid drug license is a punishable offense. India Advocacy offers expert support for document preparation, state portal filing, and post-approval compliance.
For legal and compliance support, connect with our team and ensure your pharma business starts on a strong, legal foundation.
