A Parliamentary Panel has sought stringent action against PATH, a global NGO based in Seattle, for blatantly violating norms while conducting clinical trials during which some children and women had died in Andhra Pradesh after being administered Human Papilloma Virus (HPV) vaccine meant to combat cervical cancer.
"While doing so (conducting the trial) its sole aim has been to promote the commercial interests of HPV vaccine manufacturers who would have reaped windfall profits had PATH been successful in getting the HPV vaccine included in the Universal Immunisation Programme (UIP) of the country," said the panel in its scathing report against the NGO.
The panel headed by Rajya Sabha member Amar Singh, tabled its report in the Rajya Sabha on Friday. It asked the Health Ministry to take up the matter through the External Affairs Ministry with the US for appropriate action against the NGO in case of such violations reported there. Similar trials by the NGO are being conducted in Uganda, Peru and Vietnam also. The panel said these countries should also be contacted through diplomatic channels and alerted.
Following controversy, the Health Ministry had suspended the clinical trial in 2011 in Khammam district in Andhra Pradesh, and Gujarat.
Considering the lapses and irregularities committed by PATH during the trials on tribal children in Andhra Pradesh and Gujarat in 2009, the panel also blasted the Indian Council of Medical Research and Department of Health and Research for their complete failure to perform their mandated role.
"Blurring the distinction between the UIP and PATH project due to the involvement of the State Governments in the project and ignoring the financial contribution of ICMR and the State Governments are very serious issues," hence the Ministry should investigate into lapses and take necessary action against the defaulters, the panel said.
The DHR and ICMR, said the panel, "rather, in their over-enthusiasm to act as a willing facilitator to the machinations of PATH, they have even transgressed into the domain of other bodies/agencies which deserves the strongest condemnation and strictest action against them."
The panel did not spare the Drug Controller General of India (DCGI) too for its laxity to take action against violation of ethical norms.
"The DCGI has also played a very questionable role in the entire matter. Initially, it took a call that since human subjects, as part of the studies, were receiving invasive intervention like immunization, clinical trial rules must be enforced.
"However, it remained as a silent spectator thereafter, even when its own rules and regulations were being so fragrantly violated," said the panel.