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.
State will send ₹850 crore proposal to Centre for development of Malpe harbour: Min Mankal Vaidya
Udupi: The State will submit a Rs 850 crore proposal to the Union government for the overall development of the Malpe fishing harbour, Karnataka Minister Mankal S. Vaidya announced while laying the foundation stone for a Rs 12.52 crore modernisation project of the harbour under the Pradhan Mantri Matsya Sampada Yojana (PMMSY).
“If the Union government does not consider the proposal, the State government will finance the proposed project,” The Hindu quoted Vaidya, state's Minister for Fisheries, Ports and Inland Water Transport, as saying.
Vaidya noted that Coastal Regulation Zone (CRZ) rules continue to hinder coastal development in Karnataka, preventing the implementation of projects worth Rs 2,034 crore. He stressed the need for CRZ norms in the state to be aligned with those in other states, where such regulations do not pose a barrier to coastal infrastructure and development initiatives.
Speaking at the event, Udupi-Chikkamagaluru MP Kota Srinivas Poojary said the PMMSY has revitalised the fisheries sector, enabling the implementation of several projects that benefit fishing communities nationwide. He urged the state government to prioritise dredging of estuaries and upgrading fisheries jetties to ensure year-round navigability and the safety of fishing vessels.
The Rs 12.52 crore modernisation project will focus on enhancing sanitation and water supply at the harbour, upgrading fish handling capacity, and strengthening security at the port, The Hindu quoted fisheries and ports officials as saying.
A reliable water supply and improved handling facilities are expected to speed up auctions and vessel turnarounds, while upgraded wastewater systems will help tackle long-standing issues of odour and contamination at the harbour.
_vb_39.jpeg)