Small and medium drugmakers seek two year extension on revised Schedule M norms

Small and medium drugmakers have written to Union Health Minister JP Nadda, seeking a two year extension to adhere to the revised Schedule M norm, that outlines Good Manufacturing Practices (GMP).

Drugmakers with a turnover of ₹250 crore or less had till December 2024 to adhere to the revised Schedule M of the Drugs and Cosmetics Rules (1945), that covered multiple factors including raw materials, processes, people etc. Those over ₹250 crore had till July 2024 to come up to speed with these norms. In fact, the Health Ministry was also reported to be looking at aligning drug approvals with adherence to these norms.

Explaining the call for extension upto December 2026, the Federation of Pharma Entrepreneurs (FOPE) President Harish K. Jain told businessline, the final notification (2023) had not taken on board suggestions from pharma associations representing small and medium drugmakers, and infact, more compliance features were added.

The document had features that are rigid, in terms of process for example, rather than looking at the outcome, he explained, and there was little margin given for remediation efforts, he claimed. The industry platform representing small and large entrepreneurs asked for part of the norms to be kept voluntary – in terms of product recall, quality guidelines etc.

Countering the view that stringent norms would prevent low-quality products from being sold in the country and abroad - the Gambian cough-syrup linked tragedy being a case in point, Jain said, the company named in the international incident had GMP and WHO certifications. It all comes down to enforcement, he said, adding that closures had been ordered of several manufacturers, based on the present GMP norms.

Facing closure

In their letter to the Health Minister, FOPE said, “Revised Schedule M is largely based on WHO GMP. WHO GMP is a dynamic guideline .... Hence, not mandatory. In view of the same, Part I of the GSR 999 (E) notification may be made mandatory, however, other parts may be issued only as a guideline and flexibility to be given to the manufacturers to adopt various alternative technologies to achieve final objective.”

The association pointed out, “About 20 percent of the country’s total manufacturers comply with WHO GMP requirements and out of the rest, most of them will face closure if revised Schedule M is implemented without adequate time and handholding ...”

The letter called for a graded approach to non-compliance observed during inspection - in that, it be classified as critical, major and minor as is the practice globally, and the licensee be given time to perform corrective and preventive action. “Penal action should be taken only if the licensee fails to comply satisfactorily with the observations and to take CAPA,” they said. The proposed financial support outlined by the Department of Pharmaceuticals towards upgradation of facilities to meet cGMP norms, also needed to be revisited, the letter said.