MSME Pharma Units Granted One-Year Extension for Schedule M Compliance

The Ministry of Health and Family Welfare has released a draft notification that extends the deadline for small and medium-sized pharmaceutical companies to meet the revised Schedule M standards. MSME pharma units now have until December 31, 2025, to enhance their facilities, as long as they register with the Central Drug Standards Control Organisation (CDSCO) within three months and provide their upgrade plans. This extension is intended to avoid closures due to non-compliance and gives companies additional time for necessary infrastructure improvements. The decision comes in response to industry concerns about the financial difficulties faced by smaller units. Out of India’s 10,500 pharmaceutical units, around 8,500 are part of the MSME sector. The extension is conditional, with audits scheduled after three months to verify that the promised upgrades are being carried out.

Source: Business Standard