CDSCO Suspends HCG Ethics Committee for 2 Years, Debars Investigators Over SAE Reporting Failures

The regulator further found that several SAEs and deaths had not been reported to the CLA at all. These included an injury involving Subject 32001/S under Protocol AUR107-101 on May 20, 2025; the death of Subject 10-004 under Protocol 13Y-IN-JPEC on August 30, 2021; a case of sepsis with multi-organ failure involving Subject 0002-00028 under Protocol ICA209-7C9 on January 25, 2022 followed by death on January 30, 2022; injury and subsequent death of Subject 10-023 under Protocol 13Y-IN-JPEC between June and July 2022; injury involving Subject 10-022 under the same protocol on September 5, 2022; death of Subject 00060003 under Protocol BAY1841788/21140 on December 14, 2022; SAE and subsequent death of Subject E3503001 under Protocol D910VC0001 in June 2023; injury involving Subject IN0420001 under Protocol NIVO.22.001 in August 2023; and injury involving Subject 10486 under Protocol J2J-OX-JZLC in February 2023.

The regulator also examined issues relating to participant safety oversight. One of the key observations involved Subject IN0420006. The Ethics Committee had concluded during causality assessment that the SAE involving the participant was unrelated to the investigational product and that no compensation was payable. However, CDSCO observed that the participant was suffering from progressive liver disease and lung carcinoma and questioned the committee's conclusion that the subject had recovered and been discharged in stable condition. The regulator stated that adequate evidence supporting the committee's conclusions was not available in the records examined during inspection.

Another significant finding related to conflict-of-interest management. During examination of the Minutes of Meeting dated September 25, 2024, CDSCO observed that Dr. Govind Babu signed a declaration indicating that no conflict of interest existed despite acting as Principal Investigator in the study under review. The regulator further noted that the Ethics Committee failed to properly document and manage conflict-of-interest requirements despite specific provisions contained in its own SOP No. SOP-00-v11, effective August 10, 2023. CDSCO concluded that these actions violated Rules 7(10) and 7(11) of the NDCT Rules, 2019 read with Paragraph 2.4.2.6(2) of the Indian Good Clinical Practice (GCP) Guidelines.

The inspection also identified deficiencies relating to participant safety monitoring and protocol deviation reporting. CDSCO stated that the Ethics Committee failed to adequately discharge its responsibilities under Rule 11 and Paragraph 3.2 of the Third Schedule of the NDCT Rules, 2019, particularly with respect to protection of trial participants and oversight of ongoing studies. Based on the cumulative findings, the Central Licensing Authority suspended the registration certificate of the HCG Central Ethics Committee for a period of 24 months. The committee has been directed to submit corrective and preventive action (CAPA) reports, pending causality assessment reports, compensation details wherever applicable, continue monitoring ongoing studies, and submit monthly safety reports to CDSCO Headquarters and the Bengaluru Zonal Office.

In a separate order arising from the same inspection, CDSCO debarred Principal Investigator Dr. Satheesh C.T. from conducting any new clinical trial or BA/BE study for 24 months. The regulator found that he failed to report serious adverse events, including deaths, to the Central Licensing Authority and did not adequately ensure medical management and follow-up of trial participants. Among the violations cited were the failure to report the death of Subject 10-004 under Protocol 13Y-IN-JPEC on August 30, 2021 and the failure to report the death of Subject E3503001 under Protocol D910VC0001 on June 8, 2023.

CDSCO also raised concerns regarding the management of Subject IN0420006, observing that records did not adequately demonstrate continued follow-up despite the participant suffering from progressive liver disease and lung carcinoma. The regulator noted that supporting records relating to indoor treatment, follow-up visits, and repeat liver function tests were not submitted. Furthermore, deficiencies were observed in documentation relating to trial dropouts under Protocol 13Y-IN-JPEC, where supporting documents and reasons for discontinuation of Subjects 10-011 and 10-013 were not available. The inspection also found that clinical study reports and safety follow-up records of terminated subjects after completion of Cycle 6 Day 28 had not been submitted.

CDSCO additionally identified multiple protocol deviations under Protocols NIVO.22.001 and SB27-3004 that were not promptly reported to the Ethics Committee and regulatory authorities. A substantial portion of the order focused on Subject 10486 enrolled under Protocol J2J-OX-JZLC. According to the regulator, the SAE occurred between February 1 and February 10, 2023 but was reported to the Ethics Committee and CLA only on February 17, 2023. CDSCO stated that the SAE was not reported within the required 24-hour timeline and that adequate medical management was not documented. The inspection team also found that details of medications being taken by the participant, discharge records, evidence of refusal of admission, and justification for transferring the participant from emergency services to the outpatient department were not available. Furthermore, no follow-up was conducted after discharge on February 10, 2023, and the participant subsequently died on February 11, 2023. The death was also not reported within the prescribed timeline.

Based on these findings, the Central Licensing Authority concluded that Dr. Satheesh C.T. failed to discharge his responsibilities as an investigator under the NDCT Rules, 2019, particularly with respect to SAE reporting and participant safety. Accordingly, he was debarred from conducting any new clinical trial or BA/BE study for 24 months. However, CDSCO directed him to continue supervision of ongoing studies and submit monthly participant safety reports to the regulator.

In another order issued on the same day, CDSCO separately debarred Dr. Govind Babu for six months. The action was based on findings that he signed a declaration indicating the absence of conflict of interest during an Ethics Committee meeting held on September 25, 2024 despite serving as Principal Investigator in the concerned study. The regulator also noted deficiencies relating to conflict-of-interest documentation for Protocol No. 61186372NSC3002. Holding that the conduct violated applicable provisions of the NDCT Rules and Indian GCP Guidelines, CDSCO debarred Dr. Govind Babu from undertaking any new clinical trial or BA/BE study for six months while directing him to continue monitoring ongoing studies and submit monthly participant safety reports.

The three regulatory actions collectively represent one of the most significant enforcement measures arising from a single clinical trial inspection in recent times and underscore CDSCO's increasing focus on participant safety, timely SAE reporting, robust Ethics Committee oversight, proper medical management of trial subjects, and strict adherence to conflict-of-interest requirements under India's clinical trial regulatory framework.

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