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MSME Pharma Units Granted One-Year Extension to Comply with Schedule M Standards
The deadline for compliance has now been extended to December 31, 2025, offering relief to around 8,500 Micro, Small, and Medium Enterprises (MSMEs) in the sector.
- By Newsdesk
- New Delhi
- Feb 12, 2025
The Indian government has granted small and medium-sized pharmaceutical manufacturers an additional year to align with the updated Schedule M standards, which set benchmarks for quality and Good Manufacturing Practices (GMP). The deadline for compliance has now been extended to December 31, 2025, offering relief to around 8,500 Micro, Small, and Medium Enterprises (MSMEs) in the sector.
India, a leading supplier of medicines to low- and middle-income countries (LMICs), requires WHO-GMP certification for exports. While approximately 2,000 MSME pharma units currently hold this certification, the remaining companies must upgrade their manufacturing processes to meet international standards.
In December 2023, the government revised the GMP guidelines under Schedule M of the Drugs and Cosmetics Act to bring domestic pharmaceutical manufacturing in line with global norms. Large pharmaceutical firms with an annual turnover exceeding ₹250 crore were given six months to comply, whereas MSME units were originally allotted one year.
However, MSME manufacturers sought a two-year extension, citing financial constraints in upgrading machinery and training personnel. While their request for a full two-year extension was not granted, the government has now officially provided an additional year for implementation.
The final notification amending the Drugs Rules, 1945, was issued on Wednesday, confirming the extended deadline. Industry bodies such as the Federation of Healthcare Professionals (FOPE), RSS-backed Laghu Udyog Bharati (LUB), and various state-level drug manufacturing associations had pushed for an extension until December 2026. Following stakeholder consultations, the health ministry formalized the new deadline of January 1, 2026.
However, the extension comes with conditions. MSME pharma units must submit an online application to the Central Licensing Approval Authority within three months, detailing their upgradation plans. Post this period, regulatory audits will be conducted to ensure compliance, with the government warning of strict action against units failing to implement necessary improvements.
Industry analysts estimate that MSMEs constitute roughly 8,500 of the 10,500 pharmaceutical units operating in India. With this extension, these companies now have additional time to enhance their manufacturing standards and maintain their position in the global pharmaceutical supply chain.