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In the wake of the recent cough syrup tragedy linked to Sresan Pharmaceuticals in Tamil Nadu which resulted in the death of more than 20 children, an Indian-American pharmacist and alumnus of Madurai Pharmacy College (MMC), A Manoharan has called for an urgent overhaul of India's drug regulatory system.
Manoharan, who owns four community pharmacies in America, views the crisis, which exposed deep flaws in the current framework, as a ‘turning point’ for India to establish a unified national authority similar to the US FDA, thereby strengthening central oversight. While acknowledging India's ‘proud pharmaceutical legacy’, he stressed on the immediate need for reform.
The pharmacist stated that the system’s core problems stem from its highly decentralized nature, suffering from too much local discretion, too little central oversight. State drug regulators operate independently, showing minimal coordination with the Central Drugs Standard Control Organisation (CDSCO). This fragmentation results in inconsistent quality standards and enforcement across states, as each operates separately. Further complicating the matter is the lack of transparency, with many firms remaining unregistered on national portals like SUGAM, and the outdated legal framework, the Drugs & Cosmetics Act, 1940, providing weak penalties that fail to deter violations.
To resolve these systemic failures, Manoharan urged India to adopt the unified approach of the US FDA, which operates with complete authority across states and is supported by the CDC for surveillance. He proposed six key elements to centralize and strengthen the drug safety apparatus. The first is granting CDSCO centralized authority and the final say on all manufacturing licenses. The second is establishing a unified inspection corps, one national team trained and accountable directly to the CDSCO.
The third and fourth suggestions focus on public safety mechanisms, implementing a system for rapid recall and automatic public notification for recalled or unsafe drugs, and creating a post-market surveillance link between CDSCO and drug research agencies like Indian Council of Medical Research (ICMR), Council of Scientific and Industrial Research (CSIR), CSIR-Central Drug Research Institute (CDRI), CSIR-Indian Institute of Chemical Technology (IICT), Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), Defence Research and Development Organisation (DRDO), All India Institute of Medical Sciences (AIIMS) etc and several academic research institutes, for real-time tracking of adverse events. Crucial for accountability, his fifth suggestion calls for publishing all inspection results and violations online to ensure complete transparency. The final element proposes establishing independent national labs to verify state results and act as a critical measure to prevent corruption.
Manoharan argued that the essential reform needed is centred on the guiding vision of 'One Nation, One Regulator'. Achieving this requires new legislation to create an 'Indian FDA Model', an autonomous body with authority similar to SEBI in finance or the Election Commission in governance. The CDSCO must be empowered to directly license high-risk drug categories, audit state regulators, discipline negligent officials, and transparently publish inspection data.
The MMC alumnus stressed that this regulatory strengthening is not just a domestic issue, but one of global significance. India is a vital worldwide supplier, providing around 40 per cent of US generic drugs and a large portion of WHO health programs. Therefore, strengthening regulatory credibility will not only protect Indian citizens but will also preserve global trust and reinforce India's reputation as the pharmacy of the world.
The New York based pharmacist insisted that the Tamil Nadu cough syrup scandal must be the non-negotiable turning point. He believes that strong, transparent, and centralized regulation will not only prevent future tragedies but will significantly elevate India’s standing in global healthcare. He stated it is time for India's Central agencies to have the necessary power, resources, and accountability to ensure drug safety for all citizens.
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