The Economic Times of India Jan 8, 2013
NEW DELHI: The Supreme Court has issued a notice to the government on a plea that licences for sale and marketing of Gardasil and Crevarix, vaccines for prevention of cervical cancer, should be revoked as the drugs are “unsafe” and the permits were granted without adequate research.
“Both vaccines were licensed in India without sufficient clinical trials in appropriate age groups to determine their safety and efficacy,” the public interest litigation (PIL), filed on behalf of an Andhra Pradesh-based women’s organisation, said.
Seeking a ban on their sale and use, petitioners Kalpana Mehta, Nalini Bhanot and V Rukmini Rao alleged that the drugmakers were “conducting trials” on unsuspecting women from vulnerable sections of the society without follow-up treatment or monitoring, resulting in fatalities.
The drugs have been used on thousands of adolescent girls in Gujarat and Andhra Pradesh, they said. “These vaccines had not been assessed with respect to safety and efficacy for the Indian population, where adolescent girls are overwhelmingly anemic and malnourished. No steps were taken to ensure the health and safety of the girls,” the petitioners said.
The PIL claimed that the Parliamentary Standing Committee for Health and Welfare had sought a probe into the approval for marketing of these vaccines but “this was not done”. According to the PIL, the Indian Council for Medical Research had entered into an MOU with a US-based NGO to execute a project to test the drugs.