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Drug License

License to Manufacture, Distribute & Sell Drugs & Pharmaceuticals

A Drug License is a legal requirement under the Drugs and Cosmetics Act, 1940 for any individual, partnership, or company engaged in the manufacture, distribution, sale, or import of medicines, drugs, cosmetics, and related products in India.

No person can operate in the pharmaceutical or cosmetics sector without obtaining a valid license from the State Drug Control Department or the Central Drugs Standard Control Organization (CDSCO), depending on the scale of operations.

Types of Drug Licenses

  1. Retail Drug License (RDL)

    • For chemists, medical shops, and pharmacies selling medicines directly to consumers.

  2. Wholesale Drug License (WDL)

    • For businesses engaged in wholesale distribution of drugs to retailers, hospitals, or other distributors.

  3. Manufacturing Drug License

    • For pharmaceutical companies manufacturing allopathic, ayurvedic, homeopathic, or cosmetic products.

  4. Loan Drug License

    • Issued when a manufacturer does not own a manufacturing unit but uses another company’s manufacturing facilities.

  5. Import Drug License

    • Required for importing drugs and cosmetics into India.

Eligibility Criteria

  • Business must be registered (Proprietorship / Partnership / LLP / Pvt. Ltd. Co.).

  • Premises must have a minimum 10 sq. m. for retail and 15 sq. m. for wholesale operations.

  • At least one registered pharmacist (for retail) or a competent person with experience (for wholesale) must be employed.

  • Adequate storage facility (refrigerator & air-conditioning) for temperature-sensitive drugs.

Documents Required

  • Business registration certificate (GST, Shop & Establishment, etc.)

  • Proof of premises (rental/ownership agreement & property tax receipt)

  • Pharmacist registration certificate / Qualification certificates

  • Appointment letter of pharmacist / competent person

  • Affidavit of non-conviction (owner & staff)

  • Electricity bill & site plan of premises

  • Refrigerator purchase bill (for storage compliance)

  • Application form in prescribed format

Procedure to Obtain Drug License

  1. Application Filing – Online submission on the State Drug Control Department/CDSCO portal.

  2. Document Verification – Submission of necessary documents & qualifications.

  3. Inspection – Drug Inspector visits the premises to verify compliance.

  4. Approval & Grant of License – If all requirements are met, the license is issued.

Validity & Renewal

  • A Drug License is usually valid for 5 years.

  • Renewal must be done before expiry to avoid penalties.

Benefits of Drug License

  • ✅ Legal authorization to operate in pharma & healthcare sector.

  • ✅ Builds trust & credibility with customers & hospitals.

  • ✅ Enables wholesale & retail distribution of medicines.

  • ✅ Ensures compliance with safety & quality standards.

  • ✅ Essential for manufacturing & exporting drugs.

Why Choose Us?

  • 🔹 Assistance in application & documentation

  • 🔹 Expert guidance on Retail, Wholesale & Manufacturing licenses

  • 🔹 End-to-End support with Drug Inspector approvals

  • 🔹 Quick & hassle-free process

  • 🔹 Affordable & transparent pricing