In a PIL related to quashing of licences of two vaccines used for cervical cancer treatment, the Supreme Court on Tuesday asked the Centre to file an affidavit giving details about the protocol and procedure being followed while obtaining consent before administration of these vaccines and who shall be responsible for paying compensation in case of death of any girl or for any adverse after effects.
The two drugs in question are Gardasil and Cervarix, manufactured by Merck Sharpe and GlaxoSmithKline, respectively.
A bench comprising Justice Dipak Mishra asked the Centre to file an affidavit within four weeks giving details about the steps it intends to take on the recommendations of the 81st Parliamentary Standing Committee on Health and Family Welfare, which had criticised the manner in which the vaccines were introduced in India, the protocol to be followed while obtaining consent, steps to find out the after effects of vaccine on the girls and who will be liable to pay the compensation, if required.
Apart from a recent December report of the committee, the panel had also in April 2010 recommended legal action against US-based Program for Appropriate Technology in Health (PATH) and accused the NGO of violating ethical standards while promoting the cervical cancer vaccination programme in the country.
The apex court had in August last year asked the Centre and Indian Council of Medical Research (ICMR) to produce files relating to grant of licences to pharma majors Merck Sharpe and GlaxoSmithKline for administration of two vaccines on minor girls for prevention of cervical cancer.
The bench was hearing a PIL seeking to quash licensing of two vaccines for cervical cancer treatment on the ground that approval for their use was done without adequate research on safety.