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Health Ministry in India has extended the timeline for implementation of the revised Schedule M by one year for MSMEs. The new timeline for implementation of the revised Schedule M by MSMEs (Micro Small and Medium Enterprises) with a turnover of less than Rs.250 Cr is December 2025. However, the pharma units should apply for extension of the timeline to CDSCO in Form A along with the plan of upgradation. Applications must be submitted by April 4, 2025, and extensions may be granted until December 2025.

Schedule M, part of the Drugs & Cosmetics Act of India, outlines the Good Manufacturing Practices (GMP) required for the production of pharmaceutical products in India. To align with global standards, the Indian government comprehensively revised the Schedule M GMP requirements. The Government of India issued the notification for the implementation of the revised Schedule M in December 2023.

As per G.S.R. 922(E) published in the Gazette of India on January 5, 2024, Large Pharma units (with a turnover of > Rs.250 Cr) were required to comply with the revised Schedule M within six months of its publication (by July 4, 2024). MSMEs were to implement the same in twelve months (by 4 January, 2025). The extension follows representation by several industry associations to extend the timeline for implementation of the revised schedule M for MSMEs. This extension provides MSMEs with additional time to align with global GMP standards, ensuring a smoother transition while maintaining the quality and safety of pharmaceutical products.

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