Referencing the South First report, the Commissioner of the Health and Family Welfare Department described the matter as “of serious concern” and called for an investigation into the allegations surrounding “the unfair clinical trials being conducted at HCG in Bengaluru.”
Published Jul 01, 2025 | 8:55 PM ⚊ Updated Jul 18, 2025 | 11:23 AM
Referencing the South First report, the CDSCO and the Karnataka Drug Administration have ordered an inspection.
Synopsis: Following South First exclusive report, the Karnataka government has formally urged the Drug Controller General of India (DCGI) to investigate alleged ethical violations at Bengaluru’s HealthCare Global Enterprises Ltd (HCG). The report detailed serious allegations by retired High Court judge Justice P Krishna Bhat – former Chairperson of HCG’s Ethics Committee.
The Karnataka government has written to the Drug Controller General of India (DCGI), seeking an urgent investigation into alleged irregularities in the functioning of the ethics committee and clinical trials at the Bengaluru-based HealthCare Global Enterprises Ltd (HCG) hospitals.
The move comes in the wake of an exclusive report by South First, published on Sunday, 29 June, which highlighted serious concerns about lapses in the functioning of the hospital’s Institutional Ethics Committee (IEC) – the body responsible for ensuring patient safety and ethical conduct in research.
In a letter dated 30 June 2025, Sivakumar KB, IAS, Commissioner, Health and Family Welfare Department, flagged concerns raised by the former Chairperson of the IEC, Justice P Krishna Bhat (Retd), regarding patient safety, regulatory compliance, and institutional integrity at HCG.
These include the conduct of various clinical trials, including unchecked conflicts of interest and irregularities in patient enrolment.
The letter from the Commissioner of the Health and Family Welfare Department, dated 30 June and addressed to the DCGI.
“These concerns have been flagged by none other than the chairperson of the institutional ethics committee, who has subsequently resigned,” the letter states.
“These lapses, if proven, will undermine the strict ethical principles laid down by the DCGI, DHR, ICMR, and global regulatory bodies like the WHO, which mandate the highest standards of patient safety and ethical conduct in clinical trials.”
Referencing the South First report, the Commissioner described the matter as “of serious concern” and called for an investigation into the allegations surrounding “the unfair clinical trials being conducted at Bengaluru’s HCG.”
Speaking to South First, Health Minister Dinesh Gundu Rao said,
“Based on South First’s report and some more information, our Commissioner has written to the DCGI and requested for a probe. HCG is a reputed hospital, but if any wrong has happened, we will surely take action. This is a serious matter and hence the agencies will have to look into it seriously.”
In a letter accessed by South First, the former Chairperson of the Ethics Committee at HCG, Justice P Krishna Bhat (Retd), raised several concerns regarding patient safety and the functioning of the committee.
The letter, dated 5 March 2025, was addressed to the then CEO of HCG Hospitals, Raj Gore, and the former Medical Director, Dr Harish Reddy.
Justice Bhat confirmed to South First that the letter was sent to the management following multiple discussions and concerns raised over several ethics committee meetings.
Among the key issues highlighted was an alleged conflict of interest. Justice Bhat noted in the letter that the Director of the Ethics Committee was also serving as the principal investigator (PI) for clinical trials.
He was reportedly involved in consultations with the pharmacology team to make decisions on these trials – a practice that, according to the letter, jeopardised patient safety, relaxed inclusion criteria in violation of norms, disregarded the chairperson’s recommendations, and created internal resistance to reform.
While the designation “Director of Clinical Trials” does not officially exist within an ethics committee structure, experts told South First that many institutions appoint a “Director of Clinical Trial Development” – a role typically approved at the corporate level by the CEO, Chairman, and Medical Director.
Justice Bhat, however, pointed out in his letter that during the 18 ethics committee meetings he attended, there was no instance where the individual in question stated that he was not the director.
The letter stressed the conflict of roles, asserting that Dr Sathish acted both as the PI and in a supervisory capacity – an arrangement inconsistent with ethics committee norms.
The letter also raised several other issues, including allegedly rushing through ethics committee presentations, bypassing informed reviews, undermining due process, and submitting an excessive number of trial proposals – many of which, it claimed, were inadequately explained or justified.
It further alleged that Dr Sathish directly communicated with sponsors while serving as the PI, raising concerns about possible protocol manipulation and commercial bias.
In a separate development, South First also accessed a termination notice issued by Eli Lilly and Company – a US-based multinational pharmaceutical firm – against Dr Sathish for non-compliance during the I3Y-IN-JPEC study.
The letter documented 15 violations of the dose modification protocol, involving nine patients, two of whom later died (although the deaths were deemed unrelated).
It stated that protocol violations continued despite retraining, and as a result, Lilly formally terminated HCG’s participation in another study as well.
“Eli Lilly has made the decision to terminate your site’s participation in J2J-OX-JZLC as a result of the GCP non-compliance and Serious Breach that occurred at your site for the 13Y-IN-JPEC study,” the letter reads.
Interestingly, Justice Bhat resigned a few months after the letter was sent, and within three months, the CEO, the Medical Director, and several other doctors had resigned from the company.
South First has reached out to the Chairman of the company, Dr BS Ajaikumar, seeking a response to the allegations and the letter before our investigative story was published. As of the time of publication, no response had been received.
(Edited by Dese Gowda)
