The Central Drugs Standard Control Organisation (CDSCO) has revoked the registration of seven Ethics Committees across India that oversee clinical trials.
These committees were found to have严重 violated regulatory norms, including the New Drugs and Clinical Trials (NDCT) Rules, 2019, and Good Clinical Practice (GCP) guidelines.
The action affects committees in Delhi, Pune, Navi Mumbai, Ahmedabad, and Kolkata, which are responsible for ensuring the safety and rights of participants in clinical trials.The CDSCO conducted inspections as part of a risk-based compliance exercise, identifying major non-compliances in the committees' operations.
Registrations were canceled only after completing the regulatory process, including reviewing inspection reports, corrective actions, and personal hearings.The affected committees include Rational Independent Ethics Committee, Hurip Independent Bioethics Committee, Ethiwell Ethics Committee, and others.This move underscores the regulator's commitment to maintaining strict adherence to clinical trial standards.
Original title: CDSCO cancels 7 clinical trial ethics panels over serious violations
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