The Supreme Court Tuesday asked for the file in which the Drug Controller General of India approved two Human Papillomavirus (HPV) vaccines that are used for preventing cervical cancer.
"We direct the competent authority to produce the file as per which Director General Drug Controller approved the drug for administration vaccine to prevent cervical cancer, said the apex court bench of Justice Dipak Misra and Justice V. Gopala Gowda.
The court also wanted to know the protocol required under the law assuming that the vaccine is required to carried out for administration to prevent cervical cancer.
Every year, about 73,000 women in India die of cervical cancer.
The court also asked the central government to tell it what steps it had taken on the report of parliamentary committee on ministry of health and family welfare that was submitted in September 2013.
"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 court further asked that the questions that cause concern are whether before vaccine for cervical cancer was accepted as a drug in India, did Indian Council of Medical Research (ICMR) and Director General Drug Controller (DGDC) followed the procedure for its introduction.
The court also sought response on what is the reason for choosing certain places in Gujarat and Andhra Pradesh for, what the drug companies say for "observation studies" and the PIL petitioner describes as "clinical trials".
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 GlaxoSmithKline - were "licensed in India without sufficient clinical trials in appropriate age groups to determine their safety and efficacy".
The apex court Sep 2, 2013, had issued notice to the central government on a PIL by Mehta seeking access to the research and other information on the PATH project on Human Papillomavirus (HPV) vaccine that is used for preventing cervical cancer in India to Vellore-based Christian Medical College.
US based NGO PATH - Programme for Appropriate Technology in Health - is an international organisation.
