After a Parliamentary panel severely criticized the role of the Indian Council of Medical Research (ICMR) and the Drug Controller General of India (DCGI) in the case of the trial of human papilloma virus (HPV) vaccines by international organisation PATH, the Supreme Court has pushed the Centre to the wall by seeking a report on the whole episode.

The bench, headed by Justice K S Radhakrishnan, has sought a detailed report on the investigations conducted by the Centre and the action taken on complaints of unethical clinical trials of the HPV following a PIL filed by Kalpana Mehta based on the finding by the Parliamentary Standing Committee on Health.

The petitioner said the trials were a clear case of child abuse and violated fundamental rights. The court had last year issued notices to the Centre but the government has not yet come out with an adequate response. “The anomalies in their assumed safety and efficacy were brought to the fore by various women’s groups and health groups from across the country that included a member of the National Technical Advisory Group on Immunisation,” Mehta’s petition alleged.

The Parliamentary panel had severely came done on matter, questioning the roles of ICMR and DCGI in the trials conducted by two US-based pharmaceutical companies through PATH on tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010. The trials were stopped only after the matter received media attention following the death of seven girls.

In its report on “Alleged Irregularities in the Conduct of Studies using HPV Vaccines by PATH in India” presented to Parliament, the committee has said ICMR representatives apparently acted at the behest of PATH in promoting the interests of the vaccine manufacturers, and recommended that the Health Ministry review the activities of the functionaries of the Council involved in the PATH project.

“The Department of Health Research/ ICMR have completely failed to perform their mandated role and responsibility as the apex body for medical research in the country. Rather, in their over-enthusiasm to act as a willing facilitator of the machinations of PATH, they have even transgressed into the domain of other agencies which deserves the strongest condemnation and strictest action against them,” the report said.

“The Committee is unable to understand as to how ICMR could commit itself to support "the use of the HPV vaccine" in an MoU signed in the year 2007 even before the vaccine was approved for use in the country, which actually happened in 2008. The Committee also questions the decision of ICMR to commit itself to promote the drug for inclusion in the Universal Immunization Programme (UIP) even before any independent study about its utility and rationale of inclusion in UIP was undertaken,” the panel said.

“The Committee’s examination has proved that 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. The approvals of clinical trials, marketing approval and import licenses by DCGI appear to be irregular. Therefore, the role of DCGI in this entire matter should also be inquired into,” it said.