The Central Drugs Standard Control Organisation (CDSCO) on July 13, 2026, issued a regulatory alert regarding the cancellation of Registration Certificates of Ethics Committees under the New Drugs and Clinical Trials Rules, 2019.
The following has been stated:
• It has cancelled the registration certificates of seven Ethics Committees following Risk-Based Inspections (RBI) conducted under the New Drugs and Clinical Trials (NDCT) Rules, 2019. The inspections identified significant deficiencies and major non-compliances with the NDCT Rules, Good Clinical Practice (GCP) Guidelines, and other regulatory requirements, adversely affecting the committees' ability to safeguard the rights, safety, well-being, and dignity of clinical trial participants.
• The regulatory action was taken after due process, including inspection reports, evaluation of Corrective and Preventive Action (CAPA) responses, issuance of show cause notices, and personal hearings where applicable.
• CDSCO has advised all registered Ethics Committees to ensure strict compliance with the NDCT Rules, 2019, strengthen their Quality Management Systems (QMS), maintain transparency and independence in ethical reviews, effectively manage conflicts of interest, ensure timely review of Serious Adverse Events (SAEs) and protocol deviations, maintain proper documentation, and enhance oversight of clinical trials to strengthen ethical and regulatory compliance in India.
