COMPARATIVE STUDY OF DRUG MASTER FILE (DMF) IN INDIA VS USFDA

Pranjali Amale*, Pro. Dr. B. V. Bakade, Pro. Dr. Anil Chandewar

The Drug Master File (DMF) is a confidential regulatory document submitted to drug regulatory authorities to provide detailed information regarding facilities, manufacturing processes, and raw materials used in pharmaceutical production. With globalization of pharmaceutical manufacturing and increasing international trade in Active Pharmaceutical Ingredients (APIs), understanding regulatory differences between major authorities has become essential. This research performs a comparative analysis of the DMF regulatory frameworks of the Central Drugs Standard Control Organization (CDSCO) of India and the United States Food and Drug Administration (USFDA). The study evaluates regulatory structure, documentation requirements, submission formats, review procedures, confidentiality mechanisms, and lifecycle management practices. A systematic literature review, regulatory document analysis, and comparative framework were used to analyze both systems. The results indicate that while CDSCO is progressing toward global regulatory harmonization through CTD adoption and digital platforms such as the SUGAM portal, the USFDA maintains a more mature, transparent, and scientifically rigorous DMF system supported by codified regulations under 21 CFR 314.420 and mandatory eCTD submissions. The study concludes that although CDSCO is evolving rapidly, further improvements in regulatory clarity, digital infrastructure, and lifecycle management are required to align fully with global standards.