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Clinical trialClinical 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.

The court had earlier said clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.

It had said uncontrolled clinical trial of drugs by multinational companies was creating “havoc” and slammed the Centre for failing to stop the “rackets” which caused deaths.

Observing that the government has slipped into “deep slumber” in addressing this “menace”, the court had ordered that all drug trials will be done under the supervision of the Union Health Secretary.

In an affidavit, the Centre had admitted 2,644 people died during clinical trials of 475 new drugs between 2005 to 2012.

“Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,” the affidavit had said.

“Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials,” the Centre had said.

The petition had alleged the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.


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