The Supreme Court on 17 November asked the government to ensure that express consent is taken in a transparent manner from persons on whom clinical trials are carried out.
The apex court, which was hearing a matter concerning cervical cancer vaccines, also asked the government to produce tomorrow the files of Drugs Controller General relating to issues like the procedure of taking consent of persons on whom clinical trials of such vaccines, Gardasil and Cervarix, have been carried out.
A bench of justices Dipak Misra and Shiva Kirti Singh also asked Additional Solicitor General Tushar Mehta, who appeared for Drugs Controller General of India, to apprise it about the steps taken by the regulator on the 81st report of Parliamentary Standing Committee on Health and Family Welfare, dealing with the issue of drugs relating to Human Papilloma Virus (HPV) vaccine.
"We are not venturing into the domain of the parliamentary committee," the bench said while expressing serious concern over the spread of cervical cancer.
It also asked the regulator to put its "own house in order" and ensure that "poverty stricken" people are not administered such 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," it said.
The two drugs in question are Gardasil and Cervarix, manufactured by Merck Sharpe and GlaxoSmithKline respectively.
The bench, which fixed the matter for detailed hearing tomorrow, said there has to be a proper system in place to ensure that persons, who suffer adverse effects of such vaccination, were being awarded the compensation.
During the brief hearing, senior advocate Harish Salve, appearing for one of the pharma majors, alleged that the plea be dismissed as many countries have allowed the use of the preventive vaccines.
"There is a firm called SANE WAX Inc. And it is masterminding litigation across the globe and the present lis pending before this court is part of that racket", he said, evoking sharp reaction from senior advocates Colin Gonsalves and Anand Grover, representing the petitioner who has filed the PIL against the vaccines.
Gonsalves and Grover opposed the statement leading the court to intervene saying the present case was on the "small canvas" as to whether the rules are being followed or not while administering vaccine on "poverty stricken" people.
The ASG also said the government has agreed to the sale and administration of the vaccines.
The ASG, during the hearing, also informed the court that out of 60,000 persons, who have been administered the vaccines, seven have died. But the cause of deaths are different and unconnected with the vaccination, he added.
He also told the court that the government has amended the rules relating to the consent of the persons undergoing clinical trial of a medicine or a vaccination.
Earlier, the court had asked the Centre to file its response giving details like the process of taking consent of persons on whom clinical trial of cervical cancer prevention vaccines, Gardasil and Cervarix, have been carried out.
The bench had 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 bench was hearing a PIL seeking to quash licensing of two vaccines for cervical cancer treatment as the approval for their use was done without adequate research on safety.
It was 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 papilloma virus 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 was no scientific basis to allow their administration.