The Supreme Court on Monday issued notice to the Centre on a public interest writ petition against licensing of and trials with the unproven human papillomavirus (HPV) vaccines, ostensibly to treat cervical cancer.
The petition, by Kalpana Mehta and other health activists, cited the Drugs Controller-General of India (DCGI), the Indian Council of Medical Research and others as respondents. It said Gardasil and Cervarix were hazardous HPV vaccines marketed in India by MSD Pharmaceuticals Pvt. Ltd. (a subsidiary of Merck) and GlaxoSmithKline Ltd.
The petition, before a Bench of Justices K.S. Radhakrishnan and Dipak Misra, said the DCGI had granted licence for the vaccines without adequate research on their safety and efficacy, and the Health Ministry too did not inquire into their licensing as ordered by a Parliamentary Standing Committee in April 2010.
Nor did Ministry take any action on the report of its own enquiry committee, despite all irregularities of the project being confirmed. This project was meant to influence the government to adopt these vaccines for introduction in the public sector, the petitioners said.
The vaccines were genetically engineered, whose hazards were unknown even to the scientific community, the petitioners said. “Though r-DNA has been detected in Gardasil in samples from many countries, including India, MSD Pharmaceuticals, in its application for licensing, claimed that there was no hazard because there was no r-DNA.”
GlaxoSmithKline, they alleged, used a novel technique for producing Cervarix, which involves the use of insect cells and proteins. But, “their product information admitted to their vaccine containing insect cells and proteins only in July 2011, though the vaccine had already been in use since 2007. These residues or adventitious agents enter the blood stream when the vaccine is injected and are acknowledged to have the capacity to cause infections, tumours and cancer.”
However, neither of these vaccines had been studied to determine their potential to cause cancer, the petitioners said. “In addition, the Drugs Controller has not even set standards of acceptable limits for such contamination in vaccines on the basis of which he could have found them safe for licensing.”
The petitioners said: “Though both vaccines are claimed to prevent cervical cancer, the truth is cervical cancer takes twenty or more years to develop. The vaccines have just not been around that long to prove their efficacy… If these vaccines are given to women who already are infected with the virus, then they will raise the incidence of cervical cancer.”