Discussions

The MD 42 License is a mandatory regulatory approval issued under the Drugs and Cosmetics Act, 1940, for pharmaceutical manufacturers in India. It authorizes companies to manufacture drugs for sale or distribution while ensuring strict compliance with GMP standards, quality control, and safety norms. Obtaining an MD 42 license involves documentation, facility inspection, technical staff qualification verification, and adherence to CDSCO and State Drug Authority guidelines. This forum discussion explores eligibility criteria, application procedure, timelines, common challenges, and compliance requirements related to the MD 42 license, helping pharma businesses streamline approvals and avoid regulatory delays.