Panels formed to probe into allegation of unethical human clinical trial in Jaipur
PTI Apr 23, 2018
The CDSCO has sent a three-member team to Jaipur to inquire about an alleged unethical human clinical trial conducted by a pharma company at a private hospital.
Central Drugs Standard Control Organisation has sent a panel to the Rajasthan capital to probe into an unethical clinical trial conducted at one of the private hospitals, the Drugs Controller General of India (DCGI) said on April 22. Rajasthan Health Minister Kalicharan Saraf also constituted a three-member panel to probe into the alleged incident. According to state officials, nearly two dozen people hailing from Rajasthan's Churu and Bharatpur districts were allegedly subjected to the unethical human clinical trial for an osteo-ortho drug at the hospital.
DCGI Dr S Eswara Reddy, in Delhi, said, "We have sent a team of three officials to Jaipur to inquire into the matter along with the state drug controller." Saraf said a three-member panel, headed by an additional director-level officer has been constituted to probe the matter. "Action will be taken, if lapses are found, the health minister said. The panel visited the hospital located in Vishwakarma Industrial Area to initiate the probe.
"Principal investigator and the patients enrolled in the clinical trial were not available at the site. We have asked the hospital staff to provide necessary documents related to the trial," Dr Ravi Prakash Sharma, the head of the three-member probe panel constituted by the state government, said. He said that it needs to be probed whether informed consent was obtained from the patients, whether permission was taken from state-level ethics committee or insurance policy document for patients was signed. "Prima facie, it appears that the hospital did not possess 50 beds, mandatory for conducting clinical trials," Dr Sharma said.
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