In a recent directive, India’s drug regulatory authority has mandated that small and medium pharmaceutical manufacturers seeking an extension for implementing the revised Schedule M must submit a detailed compliance strategy within three months. This strategy should include a gap analysis and a justified timeline for achieving compliance.
The revised Schedule M, which enhances good manufacturing practices (GMP), was notified in January 2024. Large manufacturers with an annual turnover exceeding ₹250 crore were required to comply by July 1, 2024, while MSMEs were initially given until January 1, 2025. However, due to requests for additional time to upgrade infrastructure and train personnel, the government has conditionally extended the deadline for MSMEs to December 31, 2025.
To qualify for this extension, companies must submit their compliance plans to the Central Licence Approving Authority online. The submission must be signed by a director, proprietor, or partner and should outline the steps the company will take to meet the revised standards. Failure to submit a plan within the stipulated three-month period may result in penalties or delays in approval processes.
Industry groups, such as the Federation of Pharma Entrepreneurs (FOPE), have advocated for this extension, citing the need for more time to improve infrastructure and increase manpower. The Health Ministry has emphasized that the revised Schedule M aims to enhance the quality and safety of pharmaceutical products, thereby strengthening India’s position in the global market.
India’s drug regulator now requires small and mid-sized pharmaceutical companies (turnover below ₹250 crore) to submit a compliance strategy within three months if they wish to extend the deadline for implementing the revised Schedule M. The strategy must include a gap analysis and timeline, signed by a company executive. This update follows industry requests for more time to meet enhanced manufacturing standards. The new deadline for MSMEs is December 31, 2025.