The Central Drugs Standard Control Organisation (CDSCO) has suspended the registration of the central ethics committee (EC) at one unit of KKR-backed HCG Oncology Hospital over alleged irregularities in clinical testing processes. According to reports from Business Standard, the CDSCO order, dated June 12, 2026, pertains to the KR Road (Bengaluru) unit of HCG, with the apex drug regulatory body citing the facility's EC for failing to report serious adverse events (SAEs), casualties and conflicts of interest during trials under the New Drugs and Clinical Trials Rules, 2019. In a major push for transparency in clinical research regulation, the CDSCO has uploaded two important documents on its official website: the list of Principal Investigators debarred by the Central Licensing Authority (CLA) and the list of suspended ethics committees, as reported by DrugsControl Media Services.
The regulatory action follows two risk-based inspections (RBIs) conducted by central and state drug regulatory authorities at HCG-Bangalore Institute of Oncology in July 2025 to assess the compliance status of its EC amid concerns over conflicts of interest, patient-safety violations and regulatory non-compliance. As reported by Business Standard, the CDSCO found deficiencies in SAE causality assessments and participant-safety oversight by HCG's EC, following which the regulator issued a show-cause notice. The order alleges that HCG's EC did not report at least three cases each of injury and death to the CDSCO within prescribed timelines and failed to provide details of four cases each of injuries and deaths caused during clinical testing. Additionally, the order states that HCG's EC failed to submit signed minutes of meetings for the year 2022 and did not procure 'no conflict of interest' disclosures from members of the KR Road unit EC.
The CDSCO order, signed by Drug Controller General of India (DCGI) Rajeev Raghuvanshi, effectively bars HCG-Bangalore from taking up new clinical trials for the next 24 months. According to Business Standard, ongoing trials will continue to be monitored, with monthly safety reports to be submitted to the CDSCO's zonal office in Bengaluru. The order directs HCG to submit corrective and preventive action (CAPA) plans and casualty assessment reports, along with compensation, if any, for the aforementioned non-reported SAEs to the Central Licensing Authority. As reported by DrugsControl Media Services, this represents a significant regulatory action that demonstrates CDSCO's commitment to maintaining high standards in clinical research.
While HCG declined to comment, the hospital chain stated in a regulatory filing to stock exchanges that it is examining the suspension order and the legal remedies available. As reported by Business Standard, HCG stated there is no significant impact on the financial operations or other activities of the company, noting that the suspension is limited to the KR Unit Ethics Committee and does not extend to other ethics committees, hospital operations, or any other unit of the company. HCG operated more than 2,600 beds across 25 facilities in India and Kenya as of March 31, 2026, and on Friday, HCG shares ended trade at ₹609 apiece, down 1.06 per cent on an intraday basis.
