Gardasil and Cervarix were approved by drugs controller even though they are unproven and hazardous, alleges petition
The Supreme Court has issued notice to the Central government and has sought response on a public interest petition that wants two vaccines against cervical cancer to be recalled.
The petition claims the vaccines were approved for use without adequate research and safety.
A bench of justices KS Radhakrishnan and Dipak Misra agreed to hear the plea last Monday after it was alleged that the Drugs Controller General of India (DCGI) issued licenses for the vaccines without necessary efficacy tests.
The petition has been filed by Kalpana Mehta, who is associated with Saheli Women’s Resource Centre, in her individual capacity and other health activists. It alleges that the vaccines — Gardasil and Cervarix — are unproven and hazardous Human Papilloma Virus (HPV) vaccines being marketed in India by MSD Pharmaceuticals Pvt. Ltd. and GlaxoSmithKline Ltd.
The petitioners have also accused statutory health bodies of turning a blind eye towards the negative impact of the vaccines in India.
The petitioners allege that non-profit Partnerships for Access to Health (PATH) signed a memorandum of understanding with Indian Council of Medical Research (ICMR) and initiated a project for introduction of the two vaccines in India in February 2007, even before they were licensed by the DCGI. The HPV vaccine is supposed to prevent infection from certain types of human papilloma viruses associated with the development of cervical cancer.
ICMR helped PATH in its trials of drugs in two states--Andhra Pradesh and Gujarat—without following the norms, which was later investigated by a committee appointed by government of India.
In its investigation, the inquiry committee concluded that there were many violations in the project as far as taking informed consent, inadequate health facilities for dealing with adverse events and medical emergencies, are concerned, say the petitioners. “These vaccines had not been assessed with respect to safety and efficacy for the Indian population where adolescent girls are overwhelmingly anaemic and malnourished. No steps were taken to ensure the health and safety of the girls. They were not screened adequately for contraindications. On the contrary, they were told that the vaccine had no adverse effects, not even those that were acknowledged by the manufacturers. No monitoring of the programme was done. No course correction was made,” say the petitioners.
As no action has been taken even after two years passed after the enquiry, the petitioners approached court seeking suspension of license of the two vaccines. “Till the government banned the PATH’s project in 2010, after objections by various activists groups, around 24,000 girls Gujarat and Andhra Pradesh had already been vaccinated by offering inducements of a free vaccine, by providing false information and by making false claims,” says the petition.
The petitioners also informed the court how the manufacturers, international NGOs, research organisations, government institutions, and even so-called charitable institutions are colluding to push the vaccine in the public health system which may be give free at first but which will make the public health system bankrupt in the long run, denying vitally needed funds for more critical sectors. All this is being done in the guise of charity to benefit private parties in the long run, the petitioners allege.
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