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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article