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SC glare on rules for vaccine, drug trials #healthcare


New Delhi, Nov. 17: The Supreme Court has directed the Centre to place by tomorrow amended rules being introduced to regulate use of vaccines and new drugs for experiments on human beings.

The new rules, the contours of which are not known, are said to have been framed on the basis of a parliamentary committee report of 2013.

Additional solicitor-general Tushar Mehta today promised the bench of Justices Dipak Misra and Shiva Kirti Singh, which heard the matter, that he would place the rules before them tomorrow.

The directive came on a PIL by a social activist, Kalpana Mehta, who alleged that a large number of women had succumbed during trials to the side-effects of certain vaccines for cervical cancer sought to be introduced in India by some MNCs.

Though the petition pertained to vaccines for cervical cancer, the Centre told the court the new rules would cover all other drugs used for experiments. The court wanted to know the protocol required under the law for testing the cancer vaccine.

Around 73,000 women in India die of cervical cancer each year.

Justice Misra, heading the bench, clarified that the court was conscious of its powers and limitations with regard to the domain of Parliament and its committees.

But the bench, he said, wanted to know what action the government had taken on the basis of the House panel report for the use of such vaccines on human beings. It was after this that additional solicitor-general Mehta offered to place the new rules.

Senior counsel Colin Gonzalves and counsel Sanjay Parekh, appearing for the petitioner, complained that a number of deaths continued to occur in the country because of the unchecked use of such trial vaccines.

But the bench observed: “Most of the malignant diseases have no cure. There are other factors like hereditary, genetic pre-disposition.”

The court indicated that if necessary, it may nominate an authority to regulate the use of such vaccines.

The bench brushed aside allegations of Gonzalves that some members of an expert committee, appointed by the Union health ministry to approve vaccines for tests, had a conflict of interest as they had accepted hospitality from the government.

“We are not going to get into all these. This is not a case of (former BCCI president) N. Srinivasan‘s conflict of interest row. But we will examine the question of granting ex-gratia and compensation in case of (vaccine) deaths,” the bench said.

The court had earlier asked the Centre to explain the basis on which the vaccine for cervical cancer was accepted as a drug in India. It wanted to know whether the Indian Council of Medical Research and the director-general drug controller had followed proper procedures for its clearance.

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