Karnataka seeks central probe into clinical trial lapses at HCG hospitals

India Today

3 days ago

The Karnataka government has written to the Central Drugs Standard Control Organisation (CDSCO), requesting an investigation into alleged irregularities in clinical trials conducted at the Bengaluru-based Healthcare Global Enterprises Ltd (HCG) hospitals. The move follows concerns raised by Justice P Krishna Bhat, a retired judge and former chairperson of the hospital's Institutional Ethics Committee (IEC) regarding patient safety and procedural violations during trial approvals.advertisementSpeaking to the media, Karnataka Health Minister Dinesh Gundu Rao said the decision to seek an inquiry stemmed from troubling reports. 'This is based on certain information we saw and received, including some news articles, and then we found out there were some issues. This is a very serious issue, and it has been raised by the ethics committee of HCG Cancer Hospital itself by their own committee, chaired by Justice Krishna Bhat,' he said.
He added that the Health Commissioner has already written to the Drug Controller General of India. 'We have asked them to look into the issue and investigate the matter, because it has serious implications regarding clinical trials and related concerns. I do not know what the truth is behind the whole thing, but it must be investigated by a responsible agency, and that is the CDSCO,' Rao said.advertisementDr BS Ajai Kumar, Founder and Chairman of HCG hospitals, responding to the allegations, issued a statement reiterating the hospital's adherence to all regulatory frameworks. 'We have noticed some unverified information about HCG, a pioneer in cancer care in India and Africa. We assure you that we strictly adhere to all guidelines set by regulatory authorities, including the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR). Currently, we are successfully conducting a significant number of trials with utmost transparency, prioritising patient safety, approved by our Ethics Committee. Our commitment to delivering exceptional care remains unwavering,' Dr Ajai Kumar said on behalf of Healthcare Global Enterprises Limited.Details of the concerns were outlined in a letter dated June 30, 2025, by Health and Family Welfare Department Commissioner Sivakumar K B, who highlighted issues raised by Justice Bhat. These included unchecked conflicts of interest and irregularities in patient enrolment during trials, as reported by South First.The letter, addressed to the Drugs Controller General of India, stated: 'These concerns have been flagged by none other than the chairperson of the institutional ethics committee, who has subsequently resigned.' It added: 'These lapses, if proven, will undermine the strict ethical principles laid down by the CDSCO, Department of Health Research, Indian Council of Medical Research, and global regulatory bodies like the World Health Organisation, which mandate the highest standards of patient safety and ethical conduct in clinical trials.'advertisementThe Commissioner described the matter as 'of serious concern' and called for a thorough probe into the allegations of 'unfair clinical trials being conducted at Bengaluru's HCG.'Justice Bhat had raised multiple concerns with then Chief Executive Officer Raj Gore and former Medical Director Dr Harish Reddy following discussions in several ethics committee meetings, in a March 5, 2025, letter, which was accessed by South First.One of the most serious issues was a potential conflict of interest involving Dr Sathish, who allegedly served as both principal investigator and in a supervisory role as Director of the Ethics Committee. Justice Bhat wrote that this dual role posed ethical risks, including compromised patient safety, dilution of inclusion criteria, and resistance to procedural reforms.The letter noted that although there is no formal post of 'Director of Clinical Trials' within ethics committees, institutions may appoint someone as 'Director of Clinical Trial Development' at the corporate level, typically endorsed by top leadership. Justice Bhat stated that during the 18 committee meetings he attended, the individual never clarified that he was not serving in such a dual capacity.advertisementAdditional concerns listed in the letter included rushed presentations, bypassing informed review processes, an excessive number of poorly explained trial proposals, and direct communication between the investigator and sponsors, which could open the door to commercial bias and protocol manipulation.- Ends
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