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Govt should only focus on quality standards as per revised Schedule M irrespective of turnover: Dr Jagashetty
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Nandita Vijayasimha, Bengaluru
October 27 , 2025
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Union government should prioritize quality standards over company turnover in the revised Schedule M of the Drugs and Cosmetics Rules, in light of the recent cough syrup tragedy. The misfortune, which involved the contamination of cough syrup with harmful substances like diethylene glycol (DEG), has highlighted critical gaps in the country’s pharmaceutical manufacturing practices, said Dr BR Jagashetty, special resource officer, Karnataka FDA, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka State Drugs Controller.
He emphasised that the focus must be on ensuring the safety and efficacy of medicines, rather than the financial performance of pharmaceutical companies.
Dr Jagashetty’s comments comes at a time when concerns regarding the growing number of substandard and counterfeit medicines are intensifying, particularly in the wake of the recent tragedy involving the Coldriff cough syrup where contamination with DEG led to the deaths of several children in MP. The incident has raised serious concerns about the current state of quality control in India's pharmaceutical manufacturing sector.
He said that ensuring the safety and efficacy of pharmaceutical products should be the primary focus, especially in the light of recent tragedies caused by substandard medicines. The cough syrup, which was linked to the deaths of several children, has raised alarms about the quality control systems in place at manufacturing units.
Stressing that while the financial performance of pharmaceutical companies is important, it should not overshadow the paramount importance of ensuring the safety and efficacy of medicines produced in the country, especially in the case of granting exemption to the revised Schedule M where deadline for compliance for large pharma with a turnover above Rs. 250 crore is June 28, 2024 and for small and medium-sized manufacturers with turnover of less than Rs. 250 crore is December 2025. Now this is biased as adherence to quality standards cannot be ignored.
The revised Schedule M governs the good manufacturing practices (GMP) in India and sets the guidelines for the pharmaceutical industry’s production processes. Dr Jagashetty pointed out that revising this deadline is absurd because quality assurance, rigorous testing, and adherence to international standards would not only safeguard public health but also elevate India's pharmaceutical reputation globally.
“Quality should never be compromised, irrespective of the size or turnover of a company. A robust regulatory framework that prioritizes product safety would encourage more investments and promote consumer confidence in India’s pharmaceutical products, both domestically and internationally,” Dr Jagashetty told Pharmabiz.
He suggested that tightening the quality control mechanisms and emphasizing compliance with updated manufacturing practices by inspecting regularly by local officers at-least once in 3 years in addition to joint inspections on RBI basis are crucial to addressing these challenges. Such reforms would not only prevent future tragedies but also restore public trust in India's pharmaceutical sector.
The call for adherence to stringent quality parameters and the revised Schedule M aligns with global efforts to ensure that the India’s pharmaceutical industry maintains the highest standards of manufacturing, a move that would benefit not only the Indian healthcare system but also the global market, said Dr Jagashetty.
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