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Produce files relating to cancer drugs licence: SC to Centre

PTI 12 Aug 2014, 21:15:30 PM IST
New Delhi: Government's approval of cervical cancer prevention vaccines Gardasil and Cervarix has come under judicial scrutiny for their alleged side effects with the Supreme Court today asking it to place before it the file relating to licences given to the manufacturing companies.  

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 Human Papilloma Virus (HPV) vaccine.  A bench comprising justices Dipak Misra and V Gopala Gowda sought from the Indian Council of Medical Research (ICMR) the file dealing with the vaccine and posted the matter for hearing on October 28.

The bench said these files are required for examining various questions raised in the 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 Gardasil and Cervarix, manufactured by pharmaceuticals major Merck Sharpe and Dohme respectively.  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.

It said that the question which is of concern is whether before the vaccine was approved for administering the drug controller, ICMR followed the procedure for its introduction.  Secondly, it has to be seen what action has been taken after the parliamentary committee submitted its report and what are the reasons of choosing certain places in Gujarat, Andhra Pradesh and Telangana for introducing the vaccine on experimental basis.

The bench also sought to know what actually caused the death of women, some of them tribal, who were subjected to the vaccine and whether proper consent was taken in this regard.  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 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.