Small and medium-sized pharmaceutical companies approached the union health ministry, requesting for a two-year extension to comply with the revised Schedule M norms, which set out the Good Manufacturing Practices (GMP) standards.
Pharmaceutical companies with a turnover of ₹250 crore or less were originally given until December 2024 to meet the updated Schedule M requirements under the Drugs and Cosmetics Rules (1945).
The rules encompass various aspects, including raw materials, manufacturing processes, and personnel. Larger companies with turnovers exceeding ₹250 crore had a deadline of July 2024 to conform to these standards. The health ministry is also considering linking drug approvals to compliance with these norms.
Harish K Jain, President of the Federation of Pharma Entrepreneurs (FOPE), expressed concerns that the final notification issued in 2023 did not incorporate suggestions from pharmaceutical associations representing small and medium-sized enterprises.
Instead, more compliance requirements were added, some of which, he argued, were rigid in terms of process rather than focusing on outcomes. Jain also pointed out that the new guidelines left little room for remediation efforts. The industry group, which includes both small and large businesses, has requested that certain aspects of the norms, such as product recall and quality guidelines, be made voluntary.
As reported by thehindubusinessline.com, addressing the argument that stricter regulations would prevent the sale of substandard products domestically and internationally – citing the Gambian cough syrup tragedy as an example – Jain noted that the company involved in that incident held both GMP and WHO certifications. He emphasized that the issue lies in enforcement, adding that several manufacturers had already been ordered to close based on existing GMP standards.
