Exclusive: Red flag raised over clinical trials at HCG

Serious questions have been raised over HCG’s clinical trials, with the institute’s Ethics Committee Chairperson himself flagging several concerns.

Published Jun 29, 2025 | 9:00 AM ⚊ Updated Jun 29, 2025 | 9:42 AM

Synopsis: HCG hospital’s former Ethics Committee Chairperson, Justice P Krishna Bhat (Retd), raised some serious questions regarding the clinical trials conducted — patients’ safety, regulatory compliance, and integrity. In 2023, a major US-based pharmaceutical firm had terminated HCG’s participation in clinical studies for violation of protocols. Adding to doubts over trials at the HCG is a WhatsApp message — later withdrawn — seeking patients from poor economic background for studies.

Clinical trials conducted at the Bengaluru-headquartered Healthcare Global Enterprises Limited (HCG) have raised serious concerns over patients’ safety, regulatory compliance, and institutional integrity.

The healthcare institute, a beacon of hope for several cancer patients, has come under a cloud of doubt after the Chairperson of HCG’s Ethics Committee — who recently resigned from the post — raised several questions. The Chairperson, it is revealed, raised disturbing questions even about the committee.

Justice P Krishna Bhat (Retd), the former Chairperson of the Ethics Committee (EC), confirmed to South First that he had noticed serious discrepancies in the EC’s functioning, prompting him to alert the institute’s management and members of the panel “at multiple meetings”.

Additionally, conversations in a WhatsApp doctors’ collective, too, raised questions about the patient group sought for clinical trials by means of profiling based on economic status.

Red flags

In a letter dated 5 March 2025, Justice Bhat flagged a series of concerns. They included unchecked conflicts of interest — the EC director himself is the principal investigator, who is also speaking to the pharmacology team to decide on clinical trials and allegedly running clinical trials. According to the letter, this practice endangers patient lives, relaxes inclusion criteria in violation of norms, ignores recommendations by the Chairperson, and creates internal resistance to reform.

Justice Bhat pointed out systemic breakdowns that went far beyond procedural lapses.

The primary role of the Ethics Committee is to independently review and monitor clinical trials to protect patient safety and ensure ethical conduct. If the EC director is also the Principal Investigator (PI) — the person leading the trial — there’s an inherent conflict.

In an ideal situation, the committee would be overseeing the work of the PI. Due to the same person holding both posts, it violates the principle of independent oversight.

South First has a copy of Justice Bhat’s letter, emailed to HCG CEO Raj Gore and Director of Medical Affairs Dr Harish Reddy. “Urgent Need for Restructuring the Role of Director of Clinical Trials to Ensure Ethical Compliance and Patient Safety,” the subject line summed up the letter’s content.

“Yes, when I was the Chairperson of the Ethical Committee at HCG Hospitals, I noticed serious concerns in the functioning of the EC. I brought it to the attention of the management and members of the EC at multiple meetings. I have recorded the concerns and flagged them in an email to both the CEO and the Director of Medical Affairs,” Justice Bhat told South First over the phone.

The mail pointed out systemic breakdowns that went far beyond procedural lapses.

A source at the hospital said no official response was made to Justice Bhat’s email. However, he was invited to meet the hospital’s Chairperson. Justice Bhat reportedly declined, but sought a meeting of the EC. As there was no formal communication from the hospital, Justice Bhat missed further EC meetings.

Also Read: Over 1,200 animals found in poor conditions at Telangana testing lab

A quiet churn

A quiet, top-level reshuffling followed the mail. CEO Gore and Dr Harish Reddy reportedly resigned. Justice Bhat stepped down. Hospital sources said at least six doctors left the institute soon after.

Justice Bhat had begun the letter with a formal escalation: “I am writing to you in my capacity as the Chairperson of the Ethics Committee at HCG to bring to your immediate attention some issues of grave concern that have been repeatedly discussed in our Committee meeting.”

The concerns, Justice Bhat claimed, remain unaddressed: “The issues remain unresolved due, what appears to me, to certain behind-the-scenes activities of some individuals interested in thwarting any effort at setting right the manner in which the Director of Clinical Trials has been functioning.”

Also Read: Kerala joins ICMR’s landmark phase-3 clinical trial

Conflict of interest

A major concern the letter raised was the dual role of Dr Sathish (Justice Bhat’s email mentioned only the first name) played as the Director of Clinical Trials and Principal Investigator (PI) or Co-PI in multiple clinical trials.

Justice Bhat said it raised a direct conflict of interest, especially since the Director also dealt directly with pharmaceutical sponsors. This, he flagged, was a fundamental conflict of interest. The Indian Council of Medical Research (ICMR) categorically stated that the director cannot be the principal investigator.

“Members of an EC should not function as investigators in the same research protocol being reviewed by the EC,” the ICMR said in its guidelines.

This is because:

• The EC must objectively assess risks, benefits, and informed consent processes.
• A PI, being personally invested in trial success, cannot review their protocol impartially.
• Allowing such dual roles erodes trust, compromises transparency, and can lead to unethical approvals, patient harm, and regulatory violations.

Dual role

Justice Bhat indicated that the Director’s dual role raised concerns over biased decision-making and commercial interests overriding patient safety.

“Being PI or Co-PI brings his position into conflict of interest, compromising on the issues of ethical concerns and institutional integrity,” the letter stated.

“After I assumed the position of the Chairman of the Ethics Committee a year ago, I noticed that he was appearing before the Ethics Committee in a large number of cases at each of the sittings [sic],” Justice Bhat wrote.

“I told the committee that it was totally unhealthy for the Director of Clinical Trials to be doing so many clinical trials,” he further said.

Justice Bhat observed that Dr Sathish presented an unusually high number of clinical trials and was often unable to answer the EC’s probing questions.

“He was rushing through his presentation before the committee, and he was finding himself in considerable difficulty to answer searching questions put by some members of the committee,” the letter said.

Also Read: Bharat Biotech begins clinical trials of TB vaccine

Who are ‘we’?

Even after raising these issues, Justice Bhat wrote that his attempts to bring in reforms were blocked. He cited an EC non-member, Monikaa D Minocha’s opposition to a proposal to limit the tenure of the Director of Clinical Trials to three years.

“We are happy to have your recommendations. But such points cannot be put in the agenda [sic],” she reportedly messaged on WhatsApp on 23 February 2025.

Mentioning that Minocha was not a member of the EC, Justice Bhat stressed a point in his letter: “Note clearly indicated that she was not speaking for himself. Whoever she was speaking for was trying to interfere with the independence and autonomy of the Ethics Committee in discharging its duties of ensuring that Clinical Trials were run on Ethical lines and the Director of Clinical Trials functioned in an ethical manner, avoiding all situations of Conflict of Interests [sic].”

The letter stated that Justice Bhat circulated a note (apparently on WhatsApp) addressing his concerns over Minocha’s “avoidable and overbearing intervention”.

Seeking to know the “we” she was referring to, Justice Bhat clarified that “The Chairman of EC is not here to look after someone’s happiness but to ensure that everything is run on ethical lines”.

Later, at an EC meeting on 26 February, Justice Bhat said Member Secretary Dr Ramesh Bilimagga surprised him. “To my total dismay,” Justice Bhat wrote, “the Member Secretary contended that there is no post of Director of Clinical Trials in HCG Hospitals and Dr Satish has never held that position”.

The letter said Dr Bilimagga had earlier never contradicted Dr Satish’s designation as the Director of Clinical Trials.

Pharma partner’s concern

South First has also accessed a termination notice issued by Eli Lilly and Company, an Indiana, US-based multinational pharmaceutical firm, to Dr Sathish for non-compliance during the I3Y-IN-JPEC study.

Lilly listed multiple failures.

The letter documented:

• 15 violations of the dose modification protocol
• Involvement of 9 patients, 2 of whom died (though deaths were deemed unrelated)
• Continued protocol violations even after retraining.

Lilly’s letter, addressed to Dr Satheesh Chiradoni Thungappa, listed multiple failures in following dosage adjustment guidelines for patients suffering from side effects, including cases of fatigue, diarrhoea, and even congestive heart failure.

“Lilly has reviewed these GCP non-compliance issues and determined that these issues meet the definition of a serious breach due to the significant impact on patient safety,” the pharma company stated on 2 February 2023.

Consequently, Lilly formally terminated HCG’s participation in another study: “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.”

Lilly formally notified the site and the lead doctor that they are shutting down the trials at this hospital. The trials—I3Y-IN-JPEC, which tested Abemaciclib along with hormonal therapy, and J2J-OX-JZLC (EMBER-3), which compared a new drug (LY3484356) to existing treatments, were aimed at women with hormone receptor-positive, HER2-negative metastatic breast cancer.

Both were being conducted under strict protocols laid out by global and Indian health authorities.

Also Read: Cancer cure pills for ₹100 a possibility soon?

Guidelines ignored

Justice Bhat also warned that repeated audits uncovered irregularities that could damage HCG’s standing with global regulators.

“Over the past few years, audits have highlighted irregularities in the conduct of clinical trials at HCG, leading to harm to patient lives and regulatory lapses,” he wrote.

He cited serious concerns about patient selection criteria: “There have been reports of inclusion criteria being relaxed to recruit more patients, thereby increasing trial profitability but endangering patient lives.”

Justice Bhat cited repeated failures to follow WHO guidelines in reporting deaths during trials — a critical requirement for transparency and patient safety. He warned that the regulatory non-adherence could deter pharmaceutical companies from partnering with HCG and result in reputational damage.

“Such lapses also undermine the strict ethical principles laid down by the DCGI, DHR, ICMR, and global regulatory bodies like WHO, which mandate the highest standards of patient safety and ethical conduct in clinical trials,” Justice Bhat cautioned.

Despite repeated alerts, Justice Bhat said no corrective action was taken. “The issues have been brought to your (CEO’s) attention on multiple occasions, including during my personal meeting with you over eight months ago,”

Doctors worried

Several doctors from HCG told South First that they are deeply disturbed by these developments. They did not want to be identified.

Members of the WhatsApp group were not impressed by Dr Sathish’s request.

“We know things aren’t right,” a Senior Oncologist said. “But we are just trying to treat patients who are suffering. We don’t want to be caught in the crossfire.”

Interestingly, a July 2025 message sent by Dr Sathish in a WhatsApp group, the “Bangalore Oncology Group,” raised further eyebrows. The doctor asked fellow members to refer patients for clinical trials: “Eligible patients financially not feasible for standard therapy in your practice, please consider a clinical trial as an option”, he said.

Several oncologists responded sharply. “It is against ethics selecting trial participants on socioeconomic status [sic],” Padma Shri Dr KS Gopinath responded in the group.

Another member, Dr PP Bansy, added: “May I, Sateesh, we can enroll, but you must not obviously bring socio-economic status as a selection criteria [sic].”

Dr Sathish later apologised: “Sorry for the previous message mentioning socio-economic status… Any eligible patients for the study can be enrolled.”

HCG’s former CEO, Gore, former Director of Medical Affairs Dr Harish Reddy, Lilly India’s Medical Director Rohit Arora, and HCG Chairman Dr BS Ajaikumar have yet to respond to queries. South First is ethically bound to publish their version of the developments mentioned above, and is awaiting their response. This report will be updated if and when they respond.

(Edited by Majnu Babu.)