EMA
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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
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A Research on the Additives and Regulatory Requirements for Pediatric Formulation
Abstract: These days, pediatric considerations are incorporated early on in the creation of new medications. The guidelines and policies of European drug regulatory bodies served as the foundation for our investigation. The review comprehensively outlines excipients commonly found in pediatric medicine formulations. It identifies potentially harmful compounds flagged by scientific literature, stressing the necessity of rigorous safety checks, often involving toxicity studies. Excipients included in pediatric databases, like the STEP database, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 28–45 Read article