Govt Extends Deadline for Pharma MSMEs to Meet Revised Schedule M Norms

Indian pharmaceutical manufacturing will receive an extension to implement the revised Schedule M standards through December 2023. The government plans to formally update drug rules over the next few days as sources signal an imminent final notification.

Pharmaceutical manufacturers, particularly MSMEs, must submit applications to ten drug regulatory authorities outlining their compliance strategies within the extended timeline. The health ministry obtained legal guidance when they introduced their draft notification to ease requirements for smaller pharmaceutical firms.

The pharmaceutical product quality standards under Schedule M of the Drugs and Cosmetics Act have been extensively disputed between stakeholders. According to the January 2022 revised standards, manufacturing facilities required to establish a pharmaceutical quality control laboratory under statutory inspection must demonstrate an Annual Turnover above ₹250 crore. MSMEs, initially required to align by January 1, 2023, have struggled with upgrading their facilities due to limited resources.

“The feedback was compiled, and the final draft has been sent to the legal affairs department for vetting,” a source told. MSME-focused extensions have been championed by lobby groups like the Federation of Pharma Entrepreneurs (FOPE), which argued for a two-year reprieve to bolster infrastructure, manpower, and training.

This anticipated extension is a significant step toward addressing the concerns of smaller pharmaceutical companies, ensuring their ability to meet the revised standards while maintaining industry growth momentum. The decision highlights the government’s balanced approach to fostering compliance and supporting MSMEs within the pharmaceutical sector.