India's pharmaceutical industry is requesting an additional two years to implement the revised manufacturing rules under Schedule M, arguing that the extension is crucial for the survival of micro, small, and medium enterprises (MSMEs). Schedule M of the Drugs and Cosmetics Rules, 1945, outlines good manufacturing practices (GMP) for pharmaceutical products, including a prompt recall system for defective products.

Pharmaceutical lobby groups have approached the health minister, seeking to extend the current December 2024 deadline to December 2026, citing resource constraints and industry challenges in meeting the revised standards.

The health ministry notified the updated Schedule M rules in January 2024. Laghu Udyog Bharati (LUB), an affiliate of RSS, and the Federation of Pharma Entrepreneurs (FOPE), representing MSME pharma units, have formally requested Health Minister J.P. Nadda to delay the implementation. "Implementing the rules by December 2024 would be too soon for MSME pharma units," Laghu Udyog Bharati stated in its letter, emphasising that more time is needed, especially with ongoing production, as a one-year period is insufficient for such an upgrade.

(ET)