SC raps govt slumber on illegal clinical trials

Shares anguish at citizens being used as guinea pigs; says committees are formed just to divert people’s attention

The Supreme Court on Thursday rapped the Centre for its failure to stop illegal clinical trials of untested drugs by multinational companies and said such drug trials are causing havoc in the country and claiming the lives of many citizens.

A Bench comprising justices R M Lodha and A R Dave said the government seems to have gone into a deep slumber on the issue and has failed to put in place a proper mechanism to stop rackets of multinational firms which are conducting illegal clinical trials.

Justice Lodha, coming down on the government said, “We want you to arrest this trend. It appears that the drugs controller is a misnomer. If he can’t do it, who will do it?”

“You have to protect the health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,” the Bench observed.

Advocate Sanjay Parikh, appearing for the petitioner, told the Bench that in the 11,000-odd clinical trials between 2005 and 2011, as many as 5,700 people had died. But, Additional Solicitor General (ASG) Siddhartha Luthra disputed the figure and said only 87 people had died.

At this, Justice Lodha asked whether these clinical trials are essential. “The last time we asked you to file an affidavit, but you filed the affidavit through a junior officer. We are rejecting it. For us, human lives are precious,” Justice Lodha remarked.

“You have slipped into deep slumber. It pains us that children of the country are being uses as guinea pigs by the companies. You do not have even respect of the Parliamentary Committee which has said that the companies are running racket and you are showing just draft rules,” the bench said when ASG Luthra contended that the Centre is considering framing rules.

“Committees are formed just to divert public attention. You set up committees and commissions so that people’s attention is diverted. We’ve given you several opportunities, but people are dying. We want to know why the government is shying away from its responsibility,” the Bench said. “It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues,” the Bench noted.

“You tell us as to what is the problem if we stop the clinical trials,” the Bench said.

It recorded an undertaking by the ASG that clinical trials of new chemical entities shall be conducted henceforth under the direct supervision of the Secretary, Ministry of Health and Family Welfare,  and directed the matter to be posted after four weeks.

On October 8, 2012, the Supreme Court had sought the replies of the Centre and various State governments to the allegation that human beings were being used as guinea pigs for clinical trials by drug companies. It had directed the Union government to come out with details of deaths, if any. edit: P8

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