Karnataka government has written to the Drug Controller General of India demanding an investigation into the alleged unfair clinical trials being conducted at the Bengaluru-headquartered Health care Global Enterprises Ltd.
The move came following allegations levelled by Justice P Krishna Bhat (Retd), former chairperson of Institutional ethics committee of HCG.
“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 enrollment. These concerns have been red flagged by none other than the chairperson of the institutional ethics committee who has subsequently resigned,” Sivakumar K B, Commissioner, Health and Family Welfare Service stated in his letter dated June 30.
According to him, these lapses, if proven will undermine the strict ethical principles laid down by the Drugs Controller General of India, Department of Health Research, Indian Council of Medical Research , and global regulatory bodies like WHO, which mandate the highest standards of patient safety and ethical conduct in clinical trials.
“Since the matter is of serious concern, I request you (DCGI) to order for an investigation into the allegations into the unfair clinical trials being conducted at Bengaluru’s HCG,” he stated.
Meanwhile, terming it as a matter of serious concern, Karnataka Health Minister Dinesh Gundu Rao said the state government has asked the DCGI to look into the issue and investigate the matter.
“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,” he told reporters here.
“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.
There was no immediate reaction from HCG.
. Read more on Nation by NDTV Profit.