Only Legally Permitted Trials Are Performed

Hyderabad, 30 Sept 2019:

Five days after allegations surfaced over unauthorised clinical trials being conducted on poor patients at Niloufer Hospital without their consent, Health department officials have denied the charges and clarified that only legally permitted clinical trials are performed in government hospitals.

The allegations made by an administrative official at Niloufer against a professor at the hospital had raised questions on the safety of patients admitted to government hospitals.

Director of Medical Education K. Ramesh Reddy said volunteers are made part of the trials after their consent is taken and the process is approved by an Ethics Committee. “People need not panic as none of those drugs is used in out-patient or in patient treatment,” Dr Reddy said.

He added that whenever a complaint comes to their notice, an inquiry is ordered and accordingly, a three-member committee has been formed to probe if all procedures were followed in the Niloufer case.

‘National Ethical Guidelines for Biomedical and Health Research involving human participants’ of the Indian Council of Medical Research (ICMR) are followed for clinical trials. After an application to conduct trials is received by Ethics Committee of an institution, it is forwarded to the medical superintendent concerned. It is the committee which gives approval.

Later, the trial has to be registered in Clinical Trials Registry of ICMR-National Institute of Medical Statistics, and the Drug Controller General of India has to give clearance, officials said. If rules laid down by the ICMR are violated, the drug trials have to be stopped. The Hindu