Overview
Drug Manufacturing License – Overview
What is a Drug Manufacturing License?
A Drug Manufacturing License is an official authorization issued by the State or Central Drug Control Authority, allowing an individual, firm, or company to manufacture drugs, pharmaceuticals, or medicinal products. It ensures compliance with the Drugs and Cosmetics Act, 1940, and guarantees the quality, safety, and efficacy of manufactured drugs.
Who is Eligible for a Drug Manufacturing License?
Individuals or proprietors planning to manufacture drugs
Partnership firms, LLPs, or companies engaged in pharmaceutical manufacturing
Units with qualified technical staff and proper manufacturing premises
Applicants meeting the norms set by the Drugs and Cosmetics Act
Importance and Benefits of a Drug Manufacturing License
Legal authorization to manufacture drugs and pharmaceutical products
Ensures adherence to safety, hygiene, and quality standards
Enhances credibility with suppliers, clients, and regulatory authorities
Avoids legal penalties, business closure, or seizure of products
Required to sell manufactured drugs to wholesalers, retailers, or institutions
Process of Obtaining a Drug Manufacturing License
Ensure manufacturing premises comply with statutory norms and hire qualified technical staff.
Prepare necessary documents, including identity, address, and business details.
Submit the application online/offline to the State or Central Drug Control Authority.
Authorities conduct an inspection of the manufacturing facility.
Upon approval, a Drug Manufacturing License is issued, allowing lawful drug production.
Documents Required for Drug Manufacturing License
PAN card and Aadhaar card of the applicant
Proof of business address and ownership/lease of manufacturing premises
Qualification certificate of technical staff and pharmacists
Detailed plant layout, machinery details, and production process
Bank account details
Application forms (Form 25/28 as applicable)
Affidavit/Indemnity bond (if required)
How NYAYAPATH LEGAL LLP Can Help You
NYAYAPATH LEGAL LLP provides complete support for Drug Manufacturing License registration and renewal. We assist in preparation of documents, application submission, coordination with authorities, and post-approval guidance. Our team ensures timely approvals while maintaining full compliance with regulatory norms, enabling you to start your manufacturing operations confidently.
