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Drug License Registration
A Drug License is a mandatory requirement for businesses involved in the manufacture, distribution, and sale of pharmaceuticals, cosmetics, and medical devices. It ensures compliance with the Drugs and Cosmetics Act, 1940, safeguarding public health by regulating the quality and safety of medicinal products.
Types of Drug Licenses
Manufacturing License – Required for pharmaceutical manufacturers.
Wholesale Drug License – Required for wholesale distribution of medicines.
Retail Drug License – Required for pharmacies and medical stores.
Import License – Required for importing drugs and medical products.
Documentation Required for Drug License
Application Form (Duly filled and signed)
Identity & Address Proof of the applicant
Premises Ownership Proof (Rent agreement/Property deed)
Affidavit regarding compliance with drug laws
Qualification Certificates of the competent person (pharmacist or registered person)
List of Equipment & Storage Facilities
Site Plan & Key Plan of the premises
Fees Payment Receipt
Benefits of Obtaining a Drug License
Legal Authorization – Ensures compliance with government regulations
Market Credibility – Builds trust with customers and stakeholders
Business Expansion – Facilitates easier expansion in the pharmaceutical sector
Prevents Legal Issues – Avoids penalties and legal actions
Ensures Public Safety – Guarantees the sale of safe and approved medicines
Compliance Requirements for Drug License Holders
Maintain proper records of stock and sales
Ensure storage facilities meet prescribed standards
Hire a qualified pharmacist (for retail drug stores)
Comply with regular inspections by the Drug Control Department
Renew the license periodically as per regulations