Sunday, Nov 23, 2014

Centre, ICMR to produce files relating to cancer drugs licence

Press Trust of India | New Delhi | Posted: August 12, 2014 3:26 pm

On Tuesday the Supreme Court directed the Centre’s competent authority to place before it the file relating to licences given for the administration of two vaccines for cervical cancer prevention.

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.

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 and posted the matter for hearing on October 28.

The two drugs in question are Gardasil and Cervarix, manufactured by Merck Sharpe and Dohme Pharmaceuticals and GlaxoSmithKline Limited, respectively.

The bench said these files are required for examining various questions raised in the Public Interest Litigation (PIL).

The bench also allowed to make Gujarat, Andhra Pradesh and Telangana as respondents in the matter because some villages in these states were chosen for administering the vaccine as an experiment and reports allegedly suggested that girls suffered side effects of these vaccines.

The bench said it had to examine whether proper protocol and procedure was followed for the introduction of these vaccines because it has been alleged that deaths have also been caused due to the situation.

The bench was hearing a PIL seeking to quash licensing of two vaccines for cervical cancer treatment on the ground that the approval for their use was done without adequate research on safety.

It has been alleged that the Drugs Controller issued licences for the vaccines without adequate research on safety as directed by Parliamentary Standing Committee on Health and Family Welfare in 2010.

Petitioner Kalpana Mehta and other health activists had alleged that 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 HPV vaccine prevents infection with certain species of human papillomavirus associated with the development of cervical cancer.

The court passed the order on the petition pleading that licences be suspended and the vaccines be recalled as there has been no scientific basis to allow their administration.

“The two companies have also flouted Indian law with impunity and have not done the post marketing studies ordered by the Drugs Controller at the time of licensing,” the plea had alleged.

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