HEALTHCARE GLOBAL ENTERPRISES

CDSCO Suspends HCG Central Ethics Committee for 24 Months Over Serious Clinical Trial Safety Violations

- India's CDSCO suspended the HCG Central Ethics Committee at HCG Bangalore Institute of Oncology for 24 months, effective June 12, 2026, barring new clinical trials. - The suspension follows a July 2025 risk-based inspection that uncovered failures to report serious adverse events, including deaths, within mandated timelines. - The Principal Investigator was debarred for six months for serving simultaneously on the Ethics Committee and signing a no-conflict-of-interest declaration. - The regulator ordered submission of CAPA, causality assessments with compensation for unreported SAEs, and monthly status reports on ongoing trials.