SC issues notice to Centre, PATH on clinical trials

The Supreme Court today issued notice to 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 of Chief Justice P Sathasivam and Justice Ranjan Gogoi also sought response from the Centre and state governments on the petition filed by an NGO Sama 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 (Program for Appropriate Technology in Health (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."

Earlier, a bench headed by Justice R M Lodha, which was hearing a batch of PILs against clinical trials, had said that trials in the country must be held to help people here and must not be allowed for the benefits of multinational companies.

The apex court had said that norms formulated by the Centre are "deficient" to protect the rights of the subjects.

It had said no trial of new drugs be allowed till consent of people subjected to trial was recorded in audio/visual medium and permitted the trial of five chemicals but refused to pass order on 157 drugs which were allowed by the Centre.