7 Clinical Trial Ethics Panels Shut Down by Drug Regulator for Serious Violations
The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of seven Ethics Committees across India responsible for overseeing clinical trials. The regulator took the action after inspections revealed serious violations of regulatory norms, including non-compliance with the New Drugs and Clinical Trials (NDCT) Rules, 2019, and Good Clinical Practice (GCP) guidelines.
The affected committees are located in Delhi, Pune, Navi Mumbai, Ahmedabad and Kolkata. Ethics Committees play a critical role in reviewing and monitoring clinical trials to protect the rights, safety and well-being of participants. The CDSCO stated that the cancellations were based on inspections conducted as part of a risk-based compliance exercise to assess adherence to regulatory requirements.
According to the regulator, the inspections identified significant deficiencies and major regulatory non-compliances in the functioning of the committees. The cancellations were finalised only after completing the full regulatory process, including evaluation of inspection reports, review of Corrective and Preventive Action (CAPA) responses, issuance of show-cause notices and personal hearings wherever applicable.
The seven committees whose registrations have been cancelled are: Rational Independent Ethics Committee, New Delhi; Hurip Independent Bioethics Committee and Dr T K Pal Memorial Bio Ethics Committee, Kolkata; Ethiwell Ethics Committee and Ethos Ethics Committee, Navi Mumbai; Institutional Ethics Committee, Aatman Hospital, Ahmedabad; and Royal Pune Independent Ethics Committee, Pune.
The CDSCO has not disclosed the specific findings against each committee. However, the action underscores the regulator's intensified oversight of clinical trial ethics in India, which has seen growing scrutiny in recent years. The cancellation means these committees can no longer review or approve new clinical trials or monitor ongoing ones.
The move is likely to have implications for clinical research in the country. Ethics Committees are essential gatekeepers for patient safety, and their failure to comply with norms can jeopardise trial participants. The CDSCO's action is intended to uphold the integrity of the clinical trial oversight system.
