SC seeks Files of Cervical Cancer Vaccine's Clinical trials on Humans

The Supreme Court taking cognizance of the alleged death of seven tribal girls in Andhra Pradesh, Telangana and Gujarat during clinical trials of a cervical cancer vaccine ordered the central drug control authority and Indian Council for Medical Research to tell how permission for human trial of the drug was given. The Court also asked the files relating to licenses given for the administration of two vaccines for cervical cancer prevention.

A bench comprising Justices Dipak Misra and V Gopala Gowda also asked the Indian Council of Medical Research (ICMR) to place before it the file dealing with the vaccine.

"What is the action taken after parliamentary committee submitted its 72 reports Sep 30, 2013," the court asked giving Director General Drug Controller, and the government four weeks' time as it directed the next hearing of the matter Oct 28.

The apex court also directed the Centre to place before it the report of Parliamentary Standing Committee on Health and Family Welfare which has dealt with the issue of drugs relating to HPV vaccine for prevention of cervical cancer. The two drugs in question are Gardasil and Cervarix, manufactured by Merck Sharpe and Dohme Pharmaceuticals and GlaxoSmithKline Limited, respectively.

The court's posers to the government, ICMR and the DGDC came in the course of the hearing of a PIL by petitioner Kalpana Mehta.

Mehta contended that Human Papillomavirus (HPV) vaccine was "unproven and hazardous", and that the anomalies in the safety and efficacy of the vaccine was brought out by the various women groups and health groups from across the country that included a member of National Technical Advisory Group on Immunisation (NTAGI).

The PIL said both the vaccines - Gardasil marketed by MSD Pharmaceutical Pvt. Ltd. and Cervarix by Glaxo Smith Kline - were "licensed in India without sufficient clinical trials in appropriate age groups to determine their safety and efficacy".

The Court further said, "We are concerned whether before drug was accepted to be used in India and whether DCGI and ICMR had followed procedure for its introduction."

The bench also sought responses from Andhra Pradesh, Gujarat and Telangana, which had granted permission for the trial.

It asked the states to explain why tribal areas were selected for trial and whether proper monitoring of the trial was done by following the laid down procedure. It also asked them to explain whether the procedure was followed in taking the consent of the girls, some of whom were minors, and what medical aid was given by the state to the affected girls.