House panel slams govt bodies over clinical trials

House panel slams govt bodies over clinical trials

A parliamentary panel has strongly reprimanded two leading central agencies – the Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) – for violating every rule in the book to go ahead with an illegal trial that would have benefited only the vaccine's manufacturers.

Intended to protect young girls against cervical cancer caused by the Human Papillomavirus (HPV), the 2009 trial was carried out by Andhra Pradesh and Gujarat governments with the approval of the ICMR and DCGI.

In the wake of several allegations of serious violation of ethical norms and the death of girls receiving the vaccine, the Centre cancelled the trial midway and instituted an inquiry, which identified “several deficiencies in the planning and implementation of the project” in its final report.

Surprisingly, the probe panel did not fix the accountability on any individual, attracting the wrath of the House panel that submitted its report on August 30.
Probe panel member Sunita Mittal, a former professor at the All India Institute of Medical Sciences, Delhi, had a “conflict of interest” as one of the HPV vaccine-manufacturing firms was sponsoring one of her research projects.

Both the DCGI and ICMR were pulled up for dereliction of duty, because of which poor and illiterate girls were exposed to the illegal clinical trial. No consent was obtained from the girls and their parents.

The ICMR went to the extent of committing itself to support “use of the HPV vaccine" in a 2007 agreement, even before the vaccine was approved for use in the country, which actually happened in 2008.

The apex medical research body acted as a “willing facilitator to the machinations of PATH”, which deserved the strongest condemnation and strictest action. The government's highest advisory body on vaccines, the National Technical Advisory Group on Immunisation (NTAGI), was bypassed.

The DCGI too played a questionable role. “It remained a silent spectator thereafter, even when its own rules and regulations were being so flagrantly violated. The approval of clinical trials, marketing approval and import licences by the DCGI appear to be irregular. The role of the DCGI should be probed,” suggests the panel.