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CDSCO Suspends HCG Bengaluru Ethics Committee for 2 Years Over Critical Clinical Trial Lapses
India’s top drug regulator, the CDSCO, has slapped a 24-month suspension on the Ethics Committee of the HCG Bangalore Institute of Oncology. Following a risk-based inspection, regulators uncovered severe compliance failures, including delayed reporting of serious adverse events (including participant deaths), glaring conflicts of interest, and inadequate medical management for trial subjects. While the committee is barred from approving new studies, it must continue monitoring active trials under strict regulatory supervision. Read on for a deep dive into the findings and what this means for clinical trial oversight in India.
Discussion Paper on “Reimagining India’s Quality Ecosystem,” published by the Research and Information System for Developing Countries (RIS), New Delhi Research and Information System for Developing Countries (RIS) is a New Delhi-based autonomous policy research institute that specializes in global…
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