Whistleblower raises alarming ethical concerns over clinical trials at Bengaluru’s HCG Hospital
Bengaluru: Serious concerns have emerged over the conduct of clinical trials at Healthcare Global Enterprises Ltd (HCG), a leading cancer hospital based in Bengaluru, after the former Chairperson of its Ethics Committee (EC), Justice P Krishna Bhat (Retd), flagged alleged violations of ethical norms, patient safety protocols, and regulatory compliance.
As reported by South First, Justice Bhat stepped down from his position citing systemic issues within the Ethics Committee and alleged conflicts of interest involving the Director of Clinical Trials, Dr Sathish. He raised these concerns in a letter dated March 5, 2025, addressed to HCG’s CEO Raj Gore and Director of Medical Affairs Dr Harish Reddy, warning that unchecked practices were putting patient safety and institutional integrity at grave risk.
In the letter as accessed by South First, Justice Bhat warned: “There is an urgent need for restructuring the role of the Director of Clinical Trials to ensure ethical compliance and patient safety.”
He highlighted a major ethical red flag, the dual role of Dr Sathish as both Director of Clinical Trials and Principal Investigator (PI) in several studies, a practice directly prohibited by Indian Council of Medical Research (ICMR) guidelines. According to ICMR norms, no EC member or affiliated person should simultaneously serve as an investigator in a trial they are overseeing.
Justice Bhat noted that the dual role created an inherent conflict of interest, with commercial pressures potentially compromising patient welfare.
South First further reported that Justice Bhat’s attempts to reform the system were allegedly stonewalled. He documented in his letter that his recommendations were blocked, even by individuals who were not part of the Ethics Committee. One such case involved Monikaa D Minocha, who reportedly interfered with the EC’s internal decisions via WhatsApp messages, despite not being an EC member.
In one instance, when Justice Bhat suggested limiting the tenure of the Director of Clinical Trials, Minocha allegedly responded: “We are happy to have your recommendations. But such points cannot be put in the agenda.”
Justice Bhat retorted in his formal note: “The Chairman of EC is not here to look after someone’s happiness but to ensure that everything is run on ethical lines.”
In a damning development, South First accessed a termination notice sent in February 2023 by Eli Lilly and Company, a major US-based pharmaceutical firm. The notice cited “serious breaches” in Good Clinical Practice (GCP) standards during the I3Y-IN-JPEC trial, including incorrect dose modifications, failure to respond to side effects, and protocol violations involving 9 patients, 2 of whom died, though their deaths were deemed unrelated.
Lilly subsequently barred HCG from further participation in its J2J-OX-JZLC trial.
“These issues meet the definition of a serious breach due to the significant impact on patient safety,” Eli Lilly stated in its letter to Dr Sathish.
In another controversial episode, Dr Sathish reportedly circulated a message in the “Bangalore Oncology Group” WhatsApp group asking doctors to refer patients who were “financially not feasible for standard therapy” for clinical trials, a move that drew criticism from leading oncologists.
Padma Shri Dr KS Gopinath strongly responded: “It is against ethics selecting trial participants on socioeconomic status.”
Dr PP Bansy echoed the sentiment: “You must not obviously bring socio-economic status as a selection criterion.”
Following the backlash, Dr Sathish withdrew the message and issued an apology.
As per South First, Justice Bhat’s letter appears to have triggered a quiet reshuffle at the top. CEO Raj Gore and Director of Medical Affairs Dr Harish Reddy reportedly resigned, and Justice Bhat stepped down from the Ethics Committee. Several doctors are also said to have exited the institution around the same time.
Despite repeated warnings by Justice Bhat, no formal institutional response was made to his March email, according to the South First report.
“The issues remain unresolved due to what appears to me to be 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,” Justice Bhat wrote in his letter.
Responding to the allegations, Dr BS Ajaikumar, Founder and Chairman of HCG, said in a statement published by South First: “We strictly adhere to all guidelines set by regulatory authorities, including DCGI and ICMR. We are currently conducting several trials with utmost transparency, prioritising patient safety.”
The Karnataka government has now initiated an inquiry into the allegations, South First confirmed. Meanwhile, HCG’s former top executives and Eli Lilly India’s Medical Director have not yet responded to queries, as reported by the South First.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
NEET student hangs self in Rajasthan's Sikar
Jaipur (PTI): A student preparing for the NEET examination allegedly committed suicide by hanging himself in a rented room in Rajasthan's Sikar on Friday, police said.
According to the police, the student allegedly hanged himself from a ceiling fan using his sister's scarf while one sister was attending coaching classes and the other was in the bathroom.
He had appeared in the NEET UG exam 2026, which was cancelled due to paper leak, they said.
Udyog Nagar SHO Rajesh Kumar said that the deceased, identified as Pradeep Meghwal, was a resident of Kanika ki Dhani village in Jhunjhunu's Gudha Gaudji area.
He had been living in a rented room in Sikar's Jaldhari Nagar area with his two sisters while preparing for NEET over the last three years.
His elder sister later found him hanging and informed the landlord and police after bringing him down, officials said.
The SHO said the body was kept at SK Hospital mortuary, and a postmortem had not been conducted.
The student's father, Rajesh Kumar Meghwal, told police that Pradeep's NEET examination had gone well and the family was expecting him to score around 650 marks.
Former Rajasthan deputy chief minister Sachin Pilot expressed grief over the incident and linked it to anxiety among students after reports of irregularities and paper leaks in NEET 2026.
Pilot said repeated paper leak incidents and cancellation of examinations were affecting students' mental health and demanded a time-bound investigation and strict action against those responsible.
