Rajya Sabha member Brinda Karat has questioned the role of the Indian Council of Medical Research (ICMR) in the controversial Human Papilloma Virus (HPV) vaccine post-licensure observational study and pointed out that some officials of the institute acted as “partisans of non-governmental organisation PATH and the interests of the manufacturing companies instead of as representatives of an institution mandated to maintain as well as ensure the implementation of the highest level of ethical standards in research studies.”
In a letter to Union Health and Family Welfare Minister Ghulam Nabi Azad on the findings of the final report of the committee that was instituted to enquire into the ethical violations during the study, Ms. Karat said the experience of this study clearly showed that it was most unwise to allow an institute such as the ICMR to go into the public-private partnership mode, as was done for this project as this gave rise to a grave conflict of interest.
Ms. Karat reiterated that her complaint was not against the HPV vaccine per se but only against gross violations in the design and implementation of the project, which was substantiated by committee reports and that compromised the safety as well as the rights of children.
The issue was about the procedures followed by the Drugs Controller General of India for giving licences for import and sale of the products by the companies concerned, in violation of the regulations of Schedule Y of the Drugs and Cosmetics Act of India.
Demanding action based on the outcome of the enquiry report, Ms. Karat said those responsible must be held accountable. Strong action was required against officials at various levels starting with the ICMR. The project itself must be scrapped and in future no NGO should be allowed to take up such a project involving a large number of children. At the same time, children must be compensated for the grave violations of their rights, Ms. Karat said.
“This project was proudly proclaimed as the first of its kind by an ICMR official. Unfortunately it turns out that the first of its kind project should also be the last of its kind if the narrow agendas of the companies pushing for the sale of their vaccines in Indian market through access to public immunisation system, are not to be the driving force behind our research studies,” she said.