As the year comes to an end, small and medium-sized drug manufacturers in India face a significant deadline in less than two months as the nation aims to ensure the production of safe and quality medicines.
After several rounds of discussions and extensions, industry insiders have come to a consensus on the importance of implementing stringent controls surrounding raw material procurement, production processes, and documentation. An assurance regarding these practices is necessary to maintain confidence in an industry renowned for supplying affordable medications both domestically and internationally.
The Health Ministry has mandated that, starting December 31, drug companies with a turnover below ₹250 crore must adhere to the revised Schedule M standards under the Drugs and Cosmetics Act of 1940, which detail good manufacturing practices (GMP). These norms had initially been rolled out for larger companies with a turnover exceeding ₹250 crore as of June 28, 2024.
Although there are informal discussions about a possible extension for smaller firms, industry insiders believe that the Centre’s approach will likely be individualized, informed by each company’s progress and commitment to compliance.
The next approximately 50 days will reveal the Health Ministry’s stance on compliance. The timing of the GMP deadline is noteworthy, especially following reported fatalities of young children in Madhya Pradesh, allegedly due to cough syrup containing the toxic substance diethylene glycol (DEG).
At a meeting earlier this month involving senior Health Ministry officials and representatives from various States and Union territories, a strong push was made for the strict adherence of all drug manufacturers to the updated Schedule M and for identifying and penalizing non-compliant units.
The drug regulatory body stated that firms applying for the Centre’s infrastructure upgradation scheme had received an extension until December and encouraged States to impose the updated GMP standards. The Department of Pharmaceuticals indicated that manufacturing units are beginning to utilize the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) to facilitate GMP compliance.
Harish K Jain, National President of the Federation of Pharma Entrepreneurs (FOPE), acknowledged the challenges ahead, asserting that companies are making strides towards meeting the new requirements. He noted that while basic GMP practices are already instituted, comprehensive documentation is required, particularly for each alternative production method employed.
FOPE has urged regulatory authorities to avoid harsh penalties for firms showing a good-faith effort to comply, even if they require additional time beyond the deadline. “People are complying, and those who are not… will voluntarily shut down,” Jain stated, estimating that out of roughly 10,000 manufacturing units, a few hundred may choose to surrender their licenses.
S Srinivasan of Locost, a producer of affordable medicines and a representative of the All India Drug Action Network (Aidan), acknowledged the financial burden on manufacturers but remarked that strict adherence to the revised Schedule M/GMP would greatly enhance the likelihood of producing high-quality products. He emphasized that possessing a GMP certificate does not guarantee the quality of all products, arguing that a commitment to public welfare and ethics is essential for producing superior pharmaceuticals.
In response to the Gambia incident in 2022, where children died due to cough syrups made in India, the Health Ministry initiated mandatory pre-export testing for such products. Jain cited data from designated labs indicating that export-oriented cough syrups tested did not contain toxic DEG. Following the Madhya Pradesh event, local samples in Karnataka were also tested and found free of EG/DEG, urging the public to retain trust in medicinal products. Jain added that the entire industry should not be unfairly portrayed in light of individual tragedies.
Regarding upgrades, Jain observed, “If we were moving at 80 kmph, we need to now work at 200 kmph.” He articulated that GMP is not a static requirement; it is continually evolving, necessitating ongoing efforts to meet higher quality standards. “There is no end point,” he suggested, affirming that companies are diligently working towards compliance, with the hope that such tragic incidents will not recur in the future. “This should be the last,” Jain echoed, reflecting a shared sentiment within the industry.
