Clinical trials in the country must be for the help of people here and must not be allowed for the benefits of multinational companies, the Supreme Court today said while holding that norms formulated by the Centre are "deficient" to protect the rights of the subjects.
The apex court said no trial of new drugs be allowed till consent of people subjected to trial is recorded in audio/visual medium and permitted the trial for five entities but refused to pass order on 157 drugs which were allowed by the Centre.
"Norms themselves are deficient to ensure that untoward incidents do not take place. You (Centre) should have a balanced approach and you cannot take one-sided view. Regime must be fool-proof. Clinical trials cannot be conducted here must help us and it must not be done for the benefit of others," a bench headed by Justice R M Lodha said.
It ordered that clinical trials for the 157 drugs must be cleared by the technical and apex committees set up by the Centre for this purpose.
The court was hearing PILs, filed by a doctor Anand Rai and NGO Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms using Indian citizens as guinea pigs in those tests.
The bench directed the committees to evaluate the application for clinical trials of drugs and take decisions by assessing risk and benefit aspects and their medical needs.
"In the light of above, it is not possible to pass order regarding 157 drugs. It can be considered only after the reports of the technical and apex committees is submitted," the bench said adding that "With regards to five cases the trial is permitted".
The bench also said the government should appoint a panel of investigators for probing the cases of clinical trials.
"How to ensure that rights of people who are subjected to clinical trial are not jeopardised? What is the mechanism in place to protect the life and avoid serious effects on the subjects"? the bench asked the Centre.
Additional Solicitor General Siddharth Luthra submitted the Centre is committed to putting in place a proper mechanism and law has to be amended for the purpose, which is under consideration.
