The Central Drugs Standard Control Organisation (CDSCO) has withdrawn registration certificates from seven Ethics Committees nationwide after risk-based audits uncovered serious lapses under the New Drugs and Clinical Trials Rules, 2019.
In a communication dated July 13 and signed by Drugs Controller General Dr Rajeev Singh Raghuvanshi, the regulator cited major non-compliances that compromised the panels’ ability to safeguard trial participants and meet Good Clinical Practice standards. Committees affected include the HuripIndependent Bioethics Committee and Dr T.K. Pal Memorial Bioethics Committee, both in West Bengal, and the Royal Pune Independent Ethics Committee in Maharashtra.
The move follows a broader compliance push by CDSCO, which recently suspended the ethics panel at a major Bengaluru cancer hospital chain for 24 months over failures to report serious adverse events, underscoring tightening oversight of clinical research safeguards across India.
Written By: Sayan Das
Graphics by: Pramit Hazra
