MSME Pharma Companies Receive Additional Year to Meet Schedule M Compliance Requirements

The Health Ministry has granted an additional year to small and medium-sized pharmaceutical companies with turnovers under Rs 250 crore to adopt revised good manufacturing practices (GMP) under Schedule M of the Drugs and Cosmetics Act. These companies must now comply by December 31, 2025. This extension follows requests from manufacturers needing more time to upgrade facilities, according to a ministry statement.

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India is a significant exporter of medicines to low and middle-income countries that require WHO GMP certification. Currently, about 2,000 MSME units in India hold this certification. The pharmaceutical manufacturing sector has advanced considerably over the past 15-20 years, enhancing our understanding of the link between manufacturing processes and product quality.

Revised GMP Standards

The government updated the GMP standards in Schedule M of the Drugs and Cosmetics Act to align with global benchmarks, particularly those of WHO. This aims to ensure Indian drugs meet international quality standards. The new Schedule M was announced in December 2023, with a transition period set for large manufacturers and MSMEs.

The Central Drugs Standard Control Organization (CDSCO), along with states and union territories, has been actively informing stakeholders about the new Schedule M requirements. Fifteen awareness sessions have been conducted across various cities, attracting 36,855 participants in hybrid formats. These sessions have been well-received, especially by MSMEs.

Implementation Timeline

Initially, units with turnovers exceeding Rs 250 crore were required to comply with the revised standards by July 1, 2023. For MSMEs, the deadline was January 1, 2025. However, industry associations representing MSMEs requested an extension due to financial constraints and the need for more time to implement necessary changes.

To support MSMEs in upgrading their facilities, a draft notification from the Department of Health and Family Welfare allows three months for registration with CDSCO and submission of an upgrade plan. A twelve-month extension is granted until December 31, 2025. After three months, audits will assess progress on these plans.

CDSCO has inspected over 800 manufacturing units and 252 public testing labs so far. Feedback from these audits indicates significant improvements in GMP compliance among MSMEs. Many units have already begun upgrading their processes, which bodes well for producing safe and high-quality pharmaceuticals in India.