Published Jun 25, 2026 | 6:38 PM ⚊ Updated Jun 25, 2026 | 6:38 PM
While CDSCO debarred Dr Govind Babu from conducting clinical trials for six months, it disqualified Dr Satheesh CT for 24 months.
Synopsis: Almost a year after South First exposed irregularities in clinical trials at Healthcare Global Enterprises Limited’s Sampangiram Nagar unit, the CDSCO, the apex drug regulator, has debarred two principal investigators from conducting studies. While one was debarred for six months, the other has been disqualified from conducting trials for two years. The CDSCO’s order mentioned glaring — and chilling — violations of ethics and norms.
The Central Drugs Standard Control Organisation (CDSCO) has debarred two principal investigators of the Healthcare Global Enterprises Limited (HCG) unit in Sampangiram Nagar, Bengaluru, from conducting new clinical trials.
The order came days after CDSCO — the apex drug regulator in the country — had suspended the registration of HCG-Bangalore Institute of Oncology’s Central Ethics Committee.
While CDSCO debarred Dr Govind Babu from conducting clinical trials for six months, it disqualified Dr Satheesh CT for 24 months.
Both investigators were at the centre of the alleged irregularities South First had reported on 29 June 2025.
The news report was published after Justice P Krishna Bhat (Retd), the then-Chairperson of HCG’s Ethics Committee (EC), had raised concerns over conflicts of interest, patient safety violations, and regulator non-compliance in a communication to the hospital management.
Following South First‘s report, the Karnataka government launched an inquiry, and the Drug Controller General of India ordered a formal inspection. A risk-based inspection was conducted, and the CDSCO suspended the EC’s registration on 12 June 2026.
Related: CDSCO suspends HCG Hospital’s Ethics Committee for 24 months
The CDSCO’s order (a copy is in the possession of South First) stated that Dr Babu, Principal Investigator at M/s Healthcare Global Enterprises Ltd, has been debarred for six months for what left Justice Bhat alarmed: a conflict of interest.
In a signed declaration made at the EC’s meeting on 25 September 2024, Dr Babu had ruled out conflict of interest, even though he was serving as the Principal Investigator in the very study the EC reviewed. He was then reportedly both the Principal Investigator and a member of the same EC.
He later admitted to a conflict of interest and stated that the declaration was made “inadvertently not obtained” for the protocol in question. It breached the New Drugs and Clinical Trials Rules (NDCTR), 2019, 7 (10) and 7 (11), and para 2.4.2.6 (2) of the Indian Good Clinical Practice (GCP) guidelines.
More serious charges led to Dr Satheesh’s debarment. The CDSCO order alleged six categories of violations, including non-reporting of patient deaths to the regulator.
Related: Red flag raised over clinical trials at HCG
The 12 June CDSCO order against Dr Satheesh detailed multiple Serious Adverse Events (SAEs) —including deaths — that were never reported to the Central Licensing Authority (CLA) within the NDCTR-prescribed timeline.
A casualty assessment report about an SAE in study 13Y-IN-JPEC that occurred on 19 August 2021 was not submitted to the CLA, the CDSCO, within the 14-day limit. In the same trial, another death that occurred on 30 August 2021, too, was not reported.
A death related to study D910VC0001 on 8 June 2023 was not reported to CLA. The CDSCO order also noted yet another death on 20 May 2025 (study AUR107-101) that, too, had gone unreported.
One SAE stood out for its clinical detail and chilling sequence of events. A subject enrolled under protocol J2J-OX-JZLC experienced an SAE on 1 February 2023. The initial report was not submitted to the EC or CLA within the mandatory 24-hour window.
Worse, the hospital did not advise further treatment but put the patient on the then-existing medications, reportedly without documenting the medications, despite the subject reporting fatigue, breathlessness, and cough.
The patient died on 11 February 2023, and the norm to intimate the EC or CLA within 24 hours of the incident was allegedly flouted.
Related: Karnataka seeks DCGI probe into HCG clinical trial
In another case involving subject ID-IN0420006, the principal investigator’s casualty assessment stated that the SAE was unrelated to the study drug. It also said that the patient had recovered and was discharged in a stable condition.
The same report, however, acknowledged that the patient was suffering from progressive liver disease with lung carcinoma (cancer). Records of follow-up care and free medical management required under NDCTR were never submitted.
CDSCO flagged Dr Satheesh’s failure to report multiple protocol deviations in 2023 to the EC and CLA, as required under Para 1 (vii) and the third Schedule of NDCTR.
Related: CDSCO orders inspection of HCG ethics committee
Justice P Krishna Bhat’s 5 March 2025 letter had specifically flagged the EC director functioning as the Principal Investigator, creating an inherent conflict of interest.
He had warned that the arrangement endangered patient lives, relaxed inclusion criteria in violation of norms, and created internal resistance to ethical oversight.
The CDSCO’s findings have now validated Justice Bhat’s warnings in regulatory terms. The debarment of Dr Babu cited the same conflict of interest — a Principal Investigator sitting on the EC reviewing his own trial.
The 24-month debarment of Dr Satheesh reflected the scale of the systemic failure that had alarmed the former EC chairperson. CDSCO’s risk analysis investigation team had found that he was the Principal Investigator in 42 out of 99 trials, with no conflict of interest declarations filed.
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Besides debarring the doctors, the CDSCO directed them to actively supervise all ongoing clinical trials and Bioavailability and Bioequivalence (BA/BE) studies and submit monthly safety and patients’ well-being reports to its headquarters and the zonal office in Bengaluru.
The CDSCO has also sent a copy of the order to the Deputy Drugs Controller (India) at its zonal office, with directions for compliance.
Meanwhile, HCG’s regulatory filing to stock exchanges after the EC suspension order stated that it was examining the order and available legal remedies. It added that there was “no significant impact on financial operations”.
The company did not respond to South First‘s request for comment on the earlier order. The report will be updated if and when HCG responds to the queries.
(Edited by Majnu Babu).
