Central Drugs Standards Control Organisation to inspect ethics panel of HCG Hospital in Bengaluru after clinical trial concerns
The inspection will take place Thursday and Friday.
The decision follows a letter from K Srinivas, commissioner of food safety and drug administration, to CDCSO, pointing to potential violations in trial conduct that could affect patient safety, regulatory compliance and institutional integrity.
The CDCSO team will assess the committee's compliance with New Drugs and Clinical Trials Rules, 2019. Officials said the review will follow a risk-based approach.
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The matter was first flagged internally by Justice P Krishna Bhat (retd), former chairperson of the hospital's ethics committee. In a letter to CEO of Health Care Global Enterprises Limited (HCG), which runs the hospital, he raised questions over the dual role played by the director of clinical trials, who also serves as principal investigator (PI) or Co-PI in several ongoing trials.
Justice Bhat argued this overlap created a conflict of interest, especially as the director interacted directly with pharmaceutical sponsors.
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He proposed dissociating the roles of director of clinical trials and PI, stating that "the director of clinical trials should not be involved in P&L [profit and loss] of clinical trials vertical, ensuring that financial incentives do not influence clinical decisions.
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He also recommended that a PI should handle only a limited number of trials to maintain accountability and ensure adherence to good clinical practice (GCP) standards set by Drugs Controller General of India (DCGI) and other regulators.
In his letter, Justice Bhat noted that "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". One example he cited was the ethics committee's repeated insistence on adherence to WHO criteria for reporting deaths during clinical trials — an expectation that he said was not consistently met when serious adverse events were presented.
Karnataka's health commissioner Sivakumar KB also wrote to DCGI on June 30, seeking an investigation into "unfair clinical trials" allegedly taking place at HCG. Justice Bhat said he had raised these matters internally through a WhatsApp group, committee meetings, and finally, a formal letter to the hospital's CEO.
Health minister Dinesh Gundu Rao told media: "Based on certain information that was received, we found out there have been some issues.
This is a very serious issue, raised by HCG hospital's ethics committee chairman Justice Krishna Bhat. The commissioner has already written a letter to DCGI to look into this issue and investigate the matter because it has got serious implications about clinical trials."
HCG Response:
We've 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 DCGI and ICMR. Currently, we're successfully conducting a significant number of trials with utmost transparency, prioritizing patient safety, approved by our ethics committee. Our commitment to delivering exceptional care remains unwavering
— Dr BS Ajaikumar, founder & chairman, HCG
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