NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of seven Ethics Committees across India overseeing clinical trials after inspections found serious violations of regulatory norms. The regulator said the committees failed to comply with the New Drugs and Clinical Trials (NDCT) Rules, 2019, Good Clinical Practice (GCP) guidelines and other requirements, compromising their ability to carry out their responsibilities.The action covers Ethics Committees in Delhi, Pune, Navi Mumbai, Ahmedabad and Kolkata, which review and monitor clinical trials to protect the rights, safety and well-being of participants.
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The CDSCO said the committees were inspected as part of a risk-based compliance exercise to assess adherence to the NDCT Rules, 2019, Good Clinical Practice guidelines and quality management systems. The inspections identified significant deficiencies and major regulatory non-compliances in the functioning of the committees.According to the regulator, the registrations were cancelled only after completion of the 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.