BENGALURU: The Health and Family Welfare Department has written to the Drug Controller General of India (DCGI), seeking an investigation into alleged unethical clinical trials at Bengaluru-based HCG Hospital, a well-known cancer care hospital chain.
The department acted after Justice P Krishna Bhat, former chairperson of the Institutional Ethics Committee (IEC) at HCG, raised serious concerns and resigned earlier this year. His resignation followed complaints about how clinical trials were being handled, especially patient safety, ethical violations and conflicts of interest.
In a letter dated June 30, the health commissioner noted that the allegations raised questions about compliance with rules and integrity of clinical research.
“These lapses, if proven, will undermine the strict ethical principles laid down by DGCI, ICMR, DHR, and bodies like WHO,” the commissioner said. Justice Bhat had written on March 5 outlining several concerns. One of the main issues was a conflict of interest — Dr Sathish, director of clinical trials at HCG, was also acting as principal investigator (PI) or co-PI in many of the clinical trials he was supposed to oversee.
This, according to medical research rules, is not allowed. ICMR states members of an ethics committee should not act as investigators in the same studies, as it affects independent judgement and patient safety.
Justice Bhat had also observed that recommendations made by the committee were ignored, inclusion criteria for patient selection were relaxed to enrol more people and questions raised by the committee were not properly answered.
He pointed out that the same doctor was appearing repeatedly before the ethics committee to present trial proposals and in many cases, could not answer the trial design.
Further concerns came to light after pharmaceutical company Eli Lilly and Company terminated HCG’s participation in a breast cancer drug trial due to protocol violations. A termination notice in 2023 listed 15 instances where the correct dose modification procedures were not followed. Lilly’s letter stated that repeated violations had a serious impact on patient safety and were classified as a ‘serious breach’ under good clinical practice standards.
Meanwhile, Central Drugs Standard Control Organisation has scheduled inspections of institutional and independent ethics committees in Bengaluru from Thursday till Saturday, under a risk-based framework.