Illegal clinical trials of drugs by MNCs wreaking havoc: SC

Slamming the Centre for failing to stop the "rackets" causing deaths due to uncontrolled clinical trial of drugs on humans, the Supreme Court on Thursday asked Union health secretary to personally ensure that such trials by multinational companies in the country are conducted only when required and that the "menace" does not result in any more deaths.

Stopping just short of banning all clinical trials until the Centre had a proper regulatory framework, a bench headed by Justice R M Lodha condemned "unnecessary trials leading to deaths" and made it clear that the secretary will be "personally responsible" for any aberration.

The apex court said the government has failed to put in place proper mechanisms to stop "rackets" of multinational companies, which are conducting illegal clinical trials, and asked it handle the problem on an urgent basis.

"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 the Additional Solicitor General Siddhath Luthra contended that Centre is considering to frame rules.

"Uncontrolled clinical trial is creating havoc in country. There has to be some some semblance of responsibility on your part," the Bench said.

Earlier, the court had discarded an affidavit by the deputy drug controller on the ongoing clinical trials and also on the use of new chemical entities, which have not been approved as drugs for human use

As per the affidavit by the deputy drug controller, between January 2005 and June 2012, a total of 475 new chemical entities were tested in the clinical trials, out of which only 17 were approved for marketing. In these clinical trials, a total number of 57,303 subjects were enrolled, and out of which a total no of 39022 subjects have completed the clinical trials. It further pointed out that 80 deaths occurred between 2008 and 2011 due to clinical trials.

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