The two drugs in question are Gardasil and Cervarix
In a PIL related to the quashing of licences of two vaccines used for cervical cancer treatment, the Supreme Court on Tuesday sought records from the Drug Controller General of India, to ascertain if proper procedures were followed during the grant of permission to multinationals to administer vaccines on minor girls for prevention of cervical cancer.
The two drugs in question are Gardasil and Cervarix, manufactured by Merck Sharpe and GlaxoSmithKline, respectively.
A bench headed by justice Dipak Misra asked additional solicitor-general Tushar Mehta to produce the records in this regard and also apprise it about the steps taken by the regulator in pursuance of the 81st report of the Parliamentary Standing Committee on Health and Family Welfare. It also posted the matter for further hearing on Wednesday.
It has been alleged that the drugs controller issued licences for the vaccines without adequate research on safety, as directed by the parliamentary standing committee on health.
“We are not venturing into the domain of the parliamentary committee,” the bench said, while expressing serious concern over the spread of cervical cancer and asked the regulator to put its “own house in order” to ensure that no “poverty-stricken” people are administered such kind of medicines without their express consent.
“The courts don’t have wisdom of medicine. Whether a particular drug should be utilised is to be seen by the drug controller. But the consent should be obtained in a transparent manner and in case of any failure, one should be compensated. A follow-up action is required in such cases,” the judges observed.
The judges also asked Gujarat, Andhra Pradesh and Telangana to file reports with regard to the deaths in their states, which were chosen for administering the vaccine on experimental basis.
Justice Mishra had last year taken cognizance of the alleged death of seven girls during clinical trials of a cervical cancer vaccine, and asked the drug control authority and the Indian Council for Medical Research to tell how permission for human trial of the drug was given.