The Central Drugs Standard Control Organization (CDSCO) has suspended the registration of the HCG Central Ethics Committee at the HCG Bangalore Institute of Oncology for 24 months. Signed by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, the order bars the committee from approving or overseeing any new clinical trials or bioequivalence (BA-BE) studies due to severe regulatory violations.
A joint Risk-Based Inspection revealed critical lapses under the New Drugs and Clinical Trial Rules (NDCTR), 2019. The committee failed to report multiple Serious Adverse Events (SAEs) to the Central Licensing Authority (CLA), including at least nine instances involving patient injuries and deaths.Numerous SAE reports were submitted well beyond legally mandated timelines. The panel failed to ensure adequate follow-up and medical care for trial participants, notably omitting a patient’s death from a timely causality assessment.An Ethics Committee member served as a Principal Investigator for trials under review without any recorded conflict declaration.
The CDSCO has ordered HCG to submit a Corrective and Preventive Action (CAPA) plan, casualty assessments, and compensation details. The committee must continue monitoring ongoing trials and submit monthly safety reports.
