Karnataka Government Seeks DCGI Investigation Into HCG Clinical Trial Ethics Violations

The Karnataka government has formally requested the Drug Controller General of India (搜索)搜索该词条 (DCGI) to investigate alleged ethical violations and regulatory non-compliance in clinical trials conducted at Bengaluru-based HealthCare Global Enterprises Ltd (搜索)搜索该词条 (HCG). The investigation follows explosive allegations by the hospital's former Ethics Committee Chairperson, retired High Court Justice P Krishna Bhat, who raised serious concerns about patient safety and institutional integrity.

In a letter dated June 30, 2025, Sivakumar KB, Commissioner of Health and Family Welfare Department, described the matter as "of serious concern" and called for an urgent investigation into "the unfair clinical trials being conducted at HCG in Bengaluru." The Commissioner referenced concerns raised by Justice Bhat regarding patient safety, regulatory compliance, and institutional integrity at the cancer (搜索)搜索该疾病 treatment facility.

Ethics Committee Conflicts of Interest

Justice Bhat's allegations center on fundamental conflicts of interest within HCG's Institutional Ethics Committee (IEC), the body responsible for ensuring patient safety and ethical conduct in research. In a March 5, 2025 letter to HCG's then-CEO Raj Gore and Medical Director Dr Harish Reddy, Justice Bhat detailed how the Director of Clinical Trials was simultaneously serving as Principal Investigator (PI) for multiple clinical trials.

"Being PI or Co-PI brings his position into conflict of interest, compromising on the issues of ethical concerns and institutional integrity," Justice Bhat wrote in his letter. The retired judge noted that this dual role violated Indian Council of Medical Research查看公司主页 (ICMR) guidelines, which categorically state that "members of an EC should not function as investigators in the same research protocol being reviewed by the EC."

Justice Bhat observed that Dr Sathish presented an unusually high number of clinical trials to the Ethics Committee and was often unable to adequately answer probing questions. "He was rushing through his presentation before the committee, and he was finding himself in considerable difficulty to answer searching questions put by some members of the committee," the letter stated.

Pharmaceutical Partner Terminates Collaboration

The concerns about protocol compliance were validated when Eli Lilly and Company查看公司主页, a major US-based pharmaceutical firm, terminated HCG's participation in clinical studies due to serious protocol violations. In a February 2, 2023 termination notice accessed by investigators, Lilly documented 15 violations of dose modification protocols during the I3Y-IN-JPEC study, involving nine patients, two of whom later died (though the deaths were deemed unrelated to the violations).

"Lilly has reviewed these GCP non-compliance issues and determined that these issues meet the definition of a serious breach due to the significant impact on patient safety," the pharmaceutical company stated. The violations included failures to follow dosage adjustment guidelines for patients experiencing side effects such as fatigue, diarrhea, and congestive heart failure.

As a consequence, Lilly terminated HCG's participation in a second study, J2J-OX-JZLC (EMBER-3), stating: "Lilly has made the decision to terminate your site's participation in J2J-OX-JZLC as a result of the GCP non-compliance and Serious Breach that occurred at your site for the 13Y-IN-JPEC study."

Patient Selection Concerns

Additional ethical concerns emerged regarding patient recruitment practices. In July 2025, Dr Sathish sent a message in the "Bangalore Oncology Group" WhatsApp group asking colleagues to refer "eligible patients financially not feasible for standard therapy" for clinical trials. The message drew sharp criticism from fellow oncologists.

Padma Shri Dr KS Gopinath responded: "It is against ethics selecting trial participants on socioeconomic status." Another member, Dr PP Bansy, added: "May I, Sateesh, we can enroll, but you must not obviously bring socio-economic status as a selection criteria." Dr Sathish later apologized and withdrew the socioeconomic criterion.

Regulatory and Safety Violations

Justice Bhat's letter detailed multiple regulatory lapses that could endanger patient safety and damage HCG's reputation with global regulators. He cited "reports of inclusion criteria being relaxed to recruit more patients, thereby increasing trial profitability but endangering patient lives" and repeated failures to follow WHO guidelines in reporting deaths during trials.

"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," Justice Bhat wrote. He warned that such violations "undermine the strict ethical principles laid down by the DCGI, DHR, ICMR, and global regulatory bodies like WHO, which mandate the highest standards of patient safety and ethical conduct in clinical trials."

Management Exodus

Following Justice Bhat's March 2025 letter, a significant management exodus occurred at HCG. Justice Bhat resigned from his position as Ethics Committee Chairperson, while CEO Raj Gore and Medical Director Dr Harish Reddy also departed. Hospital sources indicated that at least six doctors left the institution in the aftermath of these developments.

Karnataka Health Minister Dinesh Gundu Rao confirmed the government's commitment to investigating the allegations: "Based on South First's report and some more information, our Commissioner has written to the DCGI and requested for a probe. HCG is a reputed hospital, but if any wrong has happened, we will surely take action. This is a serious matter and hence the agencies will have to look into it seriously."

The investigation request highlights the critical importance of maintaining ethical standards in clinical trials, particularly at institutions treating vulnerable cancer (搜索)搜索该疾病 patients who may have limited treatment options.