CDSCO Suspends HCG Central Ethics Committee for 24 Months Over Serious Clinical Trial Safety Violations
核心洞察
India's CDSCO suspended the HCG Central Ethics Committee at HCG Bangalore Institute of Oncology (搜索) 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.
India's Central Drugs Standard Control Organisation (CDSCO) has suspended the registration certificate of the HCG Central Ethics Committee at the Bengaluru-based HCG Bangalore Institute of Oncology (搜索) for 24 months, citing multiple serious violations of the New Drugs and Clinical Trials Rules (NDCTR), 2019. The order, issued on June 12, 2026, effectively bars the Kalinga Rao Road unit of HCG Cancer Hospital from undertaking any new clinical trials or BA-BE studies for the suspension period.
The regulator also debarred Principal Investigator Dr. Govind Babu for six months after finding he simultaneously served as a member of the Ethics Committee while signing a declaration affirming no conflict of interest.
Risk-Based Inspection Triggers Enforcement
The enforcement action stems from a Risk Based Inspection (RBI) conducted in July 2025 by a team comprising officials from CDSCO headquarters, its Bengaluru zonal office, the State Licensing Authority of Karnataka, and a subject expert. The inspection assessed the compliance status of the ethics committee formed under the NDCTR at the HCG Bangalore Institute of Oncology (搜索).
A show-cause notice was subsequently issued based on alleged violations observed during the inspection. After reviewing the company's submissions, CDSCO determined that the committee failed to meet its regulatory obligations in several critical areas.
Failure to Report Serious Adverse Events
CDSCO documented eight instances where Serious Adverse Event (SAE) reports involving death or injury were submitted to the Central Licensing Authority (CLA) beyond the prescribed timeline. In nine additional cases, the committee failed to report SAEs — including deaths or injuries — to the CLA entirely, in direct violation of the NDCTR.
Under Section 42(2)(iii) of the Rules, an Ethics Committee for clinical trials must forward its report on an SAE of death — including its analysis and opinion on financial compensation — to the CLA within 30 days of receiving the investigator's report. The committee's failure to meet this obligation was a central finding in the suspension order.
Procedural and Quorum Deficiencies
The committee failed to submit Minutes of Meeting (MOM) for the year 2022 signed by the Chairperson, as required under the Rules and Indian Good Clinical Practice (GCP) guidelines. Additionally, the quorum for two meetings held in 2022 did not meet the requirements of the Rules. While the company attributed this to the Covid-19 pandemic during 2020–2022, CDSCO noted that the committee failed to conduct virtual meetings with the requisite quorum, a feasible alternative.
Patient Safety and Follow-Up Concerns
CDSCO identified lapses in the committee's oversight of trial participant safety. In one instance, the committee failed to provide documentation regarding intimation to the CLA and its opinion on medical management for two active subjects enrolled in a trial.
In another case involving a subject with progressive liver disease (搜索) and lung carcinoma (搜索), the committee opined that the SAE was not related to the study drug and that the patient had recovered and been discharged in stable condition. However, CDSCO's review of the casualty assessment report found that the trial subject had not recovered from the SAE. The regulator noted that records of follow-up, free medical management for indoor treatment, and repeat LFT testing after one week were not submitted.
A separate case involved a subject who was not provided proper management and was asked to continue existing medications. The subject was shifted from emergency to the outpatient department, and the site did not conduct follow-up after discharge on February 10, 2023. The subject died on February 11, 2023 — a fact CDSCO alleges was not considered by the committee during its causality assessment, which was submitted to the CLA 10 months later.
Protocol Deviations and Conflict of Interest
The committee informed CDSCO that protocol deviations related to a study were communicated from time to time. However, the regulator found that while the Principal Investigator reported a deviation in April 2024, several deviations that occurred in 2023 were not immediately reported to the CLA as required under the Rules.
Regarding the conflict of interest, Dr. Govind Babu signed a declaration in the September 2024 MOM stating there was no conflict of interest, despite simultaneously acting as Principal Investigator in the study and serving as a member of the Ethics Committee.
Regulatory Directives
Concluding that the committee failed to perform its responsibilities under the Rules, CDSCO ordered the 24-month suspension "in the interest of public health & the protection of human participants in clinical trials/BA-BE studies."
The regulator directed the committee to submit Corrective and Preventive Action (CAPA) along with causality assessment reports and compensation determinations, if any, for the unreported SAEs. The committee must also continue monitoring ongoing clinical trials and BA-BE studies, submitting monthly status reports on the safety and well-being of trial participants to both the CLA and the CDSCO Zonal Office in Bengaluru.
The hospital has disclosed the matter to the Securities and Exchange Board of India (SEBI), stating that it is examining the suspension order and available legal remedies, while declining to address the matter publicly.