The Karnataka government has urged the Drug Controller General of India to investigate alleged unethical clinical trials at Bengaluru’s HCG Hospital. The move follows serious concerns raised by former ethics panel chair Justice Krishna Bhat. Health Minister Dinesh Gundu Rao has called it a serious issue requiring thorough investigation.
-1751387974410_d.png "Karnataka Government writes to DCGI seeking a probe into 'unfair clinical trials' at HCG")
Representational Image. File Pic
In a shocking scenario, the Karnataka government has written to the Drug Controller General of India demanding an investigation into the alleged unfair clinical trials. The Karnataka government claims that the clinical trials that were being conducted at the Bengaluru-headquartered Health Care Global Enterprises Limited (HCG) were unfair.
The move came following allegations levelled by Justice P Krishna Bhat (Retd), former chairperson of the Institutional Ethics Committee of HCG, as per PTI.
Sivakumar K B, Commissioner, Health and Family Welfare Service, stated in his letter dated June 30 that "serious concerns have been raised over the patient's safety, regulatory compliance and institutional integrity at HCG regarding the conduct of various clinical trials, including unchecked conflict of interest and patient enrolment. These concerns have been red-flagged by none other than the chairperson of the institutional ethics committee who has subsequently resigned."
According to Sivakumar, these lapses, if proven, will undermine the strict ethical principles laid down by the Drugs Controller General of India (DCGI), Department of Health Research (DHR), Indian Council of Medical Research (ICMR), and global regulatory bodies like WHO, which mandate the highest standards of patient safety and ethical conduct in clinical trials, according to PTI.
He further stated, "Since the matter is of serious concern, I request you (DCGI) to order an investigation into the allegations of the unfair clinical trials being conducted at Bengaluru's HCG."
Meanwhile, terming the unfair clinical trials as a matter of serious concern, Karnataka Health Minister Dinesh Gundu Rao stated that the state government has asked the DCGI to look into the issue and investigate the matter with sheer seriousness.
While addressing the media about the issue, Karnataka Health Minister Dinesh Gundu Rao said, "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 Hospital itself by their own committee, chaired by Justice Krishna Bhat,” as per PTI.
"Our Commissioner has already written a letter to the Drug Controller General of India—the CDSCO (Central Drugs Standard Control Organisation)—and we've 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," he added. However, since the Karnataka government’s complaint against the unfair clinical trial, there has not been any immediate reaction from the HCG.
(With PTI Inputs)
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