The Supreme Court on Monday Nov 11,2013 issued notice to the Program for Appropriate
Technology in Health (PATH), an international NGO working in the health
sector, on a PIL alleging that it indulged in unethical conduct of
clinical trials in collaboration with ICMR between 2009-10 in Andhra
Pradesh and Gujarat.
A bench comprising Chief Justice P. Sathasivam and Justice Ranjan Gogoi
also sought a response from the central and state governments on the
petition filed by Sama, an NGO which works in the field on feminist
activism and health.
The bench tagged the case with other petitions on clinical trials being heard by a different bench.
The petitioner alleged that there were serious failures on the part of
PATH and Indian Council of Medical Research (ICMR) in complying with
legal and ethical requirements to obtain written ‘informed’ consent and
it caused serious adverse events.
“The Ethics Committees failed in their duty to protect the rights of
trial participants by allowing the trial to be conducted in young girls
from socio-economically backward families and where medical facilities
were poor or non-existent,” the petition said, adding, “The current
ethical and legal framework to protect subjects of clinical trials is
grossly inadequate and needs to be re-examined.”
About Clinical Trials
Clinical trials are sets of tests in Medical Research and Drug Development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought.
About Clinical Trials
Clinical trials are sets of tests in Medical Research and Drug Development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought.
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