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Manufacturing Drug license

A Manufacturing Drug License is an official authorization issued by a government regulatory authority—such as the Central Drugs Standard Control Organization (CDSCO) or the State Drug Control Department in India—that allows a company or individual to manufacture pharmaceutical products for sale or distribution.

Key Points:

  • Legal Requirement: Mandatory under the Drugs and Cosmetics Act, 1940 for anyone intending to manufacture drugs or medicines.

  • Issued By: Central or State Drug Control Authority, depending on the drug type (e.g., allopathic, ayurvedic, homeopathic).

  • Types:

    • Form 25 – For allopathic drug manufacturing.

    • Form 28 – For ayurvedic or herbal drug manufacturing.

    • Form 25A / 25B – For repacking or loan licenses.

Purpose:

To ensure that the drugs manufactured meet quality, safety, and efficacy standards, and are produced in Good Manufacturing Practices (GMP) certified facilities.

Documents Required:

  1. Site master plan and layout.

  2. Details of technical staff (qualified pharmacists/chemists).

  3. Equipment and machinery list.

  4. Proof of GMP compliance.

  5. Drug formulations and labels.

In short, a Manufacturing Drug License is a critical regulatory permit for producing medicines, ensuring that only safe and effective drugs enter the market under controlled and inspected conditions.