Government Extends Deadline for MSMEs to Implement Schedule M Standards

The government has granted a one-year extension to small and medium-sized pharmaceutical companies (with annual turnover below Rs 250 crore) to meet the revised Schedule M standards, which set quality standards and good manufacturing practices (GMP). The new deadline is December 31, 2025, for approximately 8,500 MSME pharmaceutical units to adopt the updated standards.

India is a significant exporter of medicines to low- and middle-income countries that require WHO GMP certification. Currently, around 2,000 MSME units in the country hold this certification, while the remaining units need to make significant efforts to comply.

The government recently revised the GMP guidelines in Schedule M of the Drugs and Cosmetics Act to align with global standards, particularly those of the WHO, to ensure that drug production meets internationally acceptable quality.

The Union Health Ministry notified these guidelines in December 2023, giving large pharmaceutical companies (with turnovers exceeding Rs 250 crore) six months to comply, which they did. However, MSME firms requested a two-year extension due to challenges with financing machinery and training staff. As a result, they have been granted an additional year to implement the changes.

On Wednesday, the Health Ministry released the final notification amending the Drugs Rules, 1945, officially extending the deadline for small pharma companies until the end of 2025. Industry associations, including the Federation of Healthcare Professionals (FOPE), Laghu Udyog Bharati (LUB), and various state drug manufacturing associations, had advocated for a further extension until December 2026.