Notice to Centre on unethical clinical trials

The Supreme Court on Monday sought the Centre’s response on a public interest litigation (PIL) alleging that unethical clinical trials of human papilloma virus (HPV) vaccines were conducted by an international NGO working in collaboration with Indian Council for Medical Research (ICMR) during 2009-10 in Andhra Pradesh and Gujarat.

A bench of Chief Justice P Sathasivam and Justice Ranjan Gogoi also issued notice to the NGO, the Program for Appropriate Technology in Health (PATH), on the petition filed by a group of NGOs, including Drug Action Forum from Karnataka, working towards health and women issues.

The bench tagged the case with other petitions on clinical trials being heard by a different bench. According to the petitioner, there were “serious failures” on the part of the PATH and the ICMR in complying with legal and ethical requirements to obtain written “informed” consent and that 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 on young girls from socio-economically backward families and where medical facilities were poor or non-existent,” the petition said.