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:
Site master plan and layout.
Details of technical staff (qualified pharmacists/chemists).
Equipment and machinery list.
Proof of GMP compliance.
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.