The Centre has advised the state governments to suspend the human papilloma virus vaccine programme in the wake of reports of violation of ethical guidelines and exploitation during the clinical trials of the vaccine for preventing cervical cancer among women. Director-General of the Indian Council of Medical Research V.M. Katoch had asked the Health Ministry, the State governments and the people not to go ahead with the programme. The Director General said that if there are allegations on part of the NGO, they need to be investigated and concrete evidence has to be brought to the notice.
Dr. Katoch said a memorandum was signed with PATH-International in February 2007 for a project allotted to it by the Bill and Melinda Gates Foundation for assessing the feasibility of introducing HPV vaccine in India. Merck and GSK were to provide the vaccine and ICMR helped in protocol preparation. Initially, the NGO conducted a survey of the social acceptability of the project with the help of a questionnaire among the socially disadvantaged groups, as cervical cancer occurred more among the women from the disadvantaged sections with less health facilities and low-capacity for buying expensive drugs. By the time the trial ended, the Drugs-Controller of India gave approval for marketing the two vaccines.
Pointing out that the trial started after approval from the State Advisory Committees and the ethical committees of the Andhra Pradesh and Gujarat governments and the National Technical Advisory Group as per the agreement with the NGOs, Dr. Katoch said that everything was going fine until complaints were received of violation of guidelines and exploitation of people from civil society groups some months ago following the death of four girls, who were given this vaccine.
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