SC asks Centre to respond on clinical trial of vaccines

New Delhi: Supreme Court on Tuesday asked the Centre to file its response giving details like process of taking consent of persons on whom clinical trial of cervical cancer prevention vaccines, Gardasil and Cervarix, have been carried out.

A bench of justices Dipak Misra and Prafulla C Pant asked the Centre to also indicate who would be liable to pay compensation to the persons if the clinical trial of the vaccination caused adverse impact.

Besides the Centre, the bench also asked governments of Gujarat, Andhra Pradesh and Telangana, where clinical trials of the vaccines have taken place, to file their responses within four weeks about issues including the number of affected persons.

The bench asked the Centre to keep in view the 81st report of the Parliamentary Standing Committee on clinical trial of vaccines while filing its response.

During the hearing, the counsel for Gujarat said seven deaths were reported from the state and moreover, these did not happen due to the clinical trials but were rather caused by reasons including snake bites.

The court, however, did not concur with the submission.

Earlier, the court had asked the Centre to place before it the records regarding the licenses given to cervical cancer prevention vaccines, Gardasil and Cervarix.

It had 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.

The court had allowed to make Gujarat, Andhra Pradesh and Telangana as respondents in the matter as some villages in these states were chosen for administering the vaccine as an experiment and reports had 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 introduction of these vaccines because it has been alleged that deaths have also been caused due to the situation.

The court had said that the question of concern was 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 were 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.