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Indian drug regulators should show zero tolerance on quality issues as patient safety is non-negotiable: Dr Jagashetty
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Nandita Vijayasimha, Bengaluru
November 11 , 2025
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Indian drug regulatory authorities should show zero tolerance on quality of drugs as patient safety is non-negotiable, said Dr. BR Jagashetty, special resource officer, Karnataka FDA, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka State Drugs Controller.
The recent episode of Coldrif cough syrup addresses the failure in Indian pharmaceutical safety system in spite of Schedule M or revised Schedule M especially with respect to GMP or quality by design, he added.
Noting that upholding public health is a regulator's unwavering mandate, Dr Jagashetty said he had ensured every medicine in the supply chain is not just effective, but fundamentally safe.
A drugs controller’s role extends beyond paperwork and needs relentless commitment to public health. It involves meticulously vetting of every license, overseeing inspection schedules, and ensuring that manufacturers adhere to the highest standards. We pioneered efforts to strengthen the Karnataka Drug Laboratories, knowing that robust, independent testing is the bedrock of quality assurance, he said.
Dr Jagashetty noted that the recent tragedies involving contaminated syrups are a stark and painful reminder that vigilance must be perpetual. The root cause often lies in a catastrophic failure of basic GMP specifically, quality control over raw materials and excipients.
From the regulatory perspective, there is zero tolerance for shortcuts and adherence to revised Schedule M is mandatory. For decades, many small and medium enterprises operated with outdated infrastructure. Revised Schedule M forces a necessary modernization drive ensuring facilities meet international standards, concerning risk-based assessment and validation irrespective of their turnover. There must be swift implementation without compromise by focusing on quality by design with proper planning from receipt of raw material, packaging material to finished products and testing at all stages including any probable impurities, Dr Jagashetty told Pharmabiz.
The State Drugs Administration Wing of FDA needs highly trained personnel as presently several vacancies exist especially basic inspectorate officers. Inspection and surveillance cannot be sporadic; they must be continuous, proactive, and deeply technical to catch sophisticated lapses like diethylene glycol (DEG) or ethylene glycol (EG) impurities or contamination at the source or down the line at production stage, he noted.
Drug Administration cannot operate in silos and needs seamless integration between the CDSCO, State regulators, and a robust national pharmacovigilance program. A single, adverse event must trigger an immediate, unified response nationwide. We need Intelligence branches across state and central administration including an Emergency Response Cell to halt the distribution of any suspect batch instantly, followed by rapid investigation and fast-track, deterrent punishment, said Dr Jagashetty.
There is need for a Paediatric Drug Safety Authority to overlook the safety, efficacy, and ethical testing of medicines, including monitoring for various impurities like DEG/EG under the chairmanship of respective state drugs controller or Commissioner, FDA with experts nominated by the government, he noted.
As forethought of the Karnataka Principal Secretary of Health and Family Welfare Department and Commissioner, FDA inspections of all manufacturing units in Karnataka as per revised Schedule M started last month before the DCGI circular dated November 7, 2025 with suitable actions by State Licensing Authority wherever found not complied, he said.
India being the ‘Pharmacy of the World’, our global reputation hinges on the quality of every single dose sold, whether exported or consumed domestically. By enforcing rigorous quality standards, championing ethical practices, and fostering an unbreakable bond of trust between the regulator, manufacturer, and public, we will have to ensure that health and safety remain our primary and sacred mandate, said Dr Jagashetty.
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