SC raps govt on clinical trials, makes Health Secy liable

Stopping short of banning clinical trials until the Centre has a proper regulatory framework, the Supreme Court on Thursday made the Union Health Secretary liable for personal supervision to ensure drug trials are conducted only when required and the "menace" does not result into any more deaths.

A Bench, led by Justice R M Lodha, condemned "unnecessary trials leading to deaths" and made it clear that the order to ban all trials was not being passed only on the assurance that the Health Secretary will make sure that all clinical trials are henceforth conducted as per rules, under his supervision. The SC noted that the Secretary will be "personally responsible" for any aberration.

Earlier, the court had discarded an affidavit by the Deputy Drug Controller on the ongoing clinical trials and on the use of new chemical entities, which have not been approved for human use. Observing that the government was "shying away" from coming out with truth, the Bench underlined that the affidavit had to be filed by a senior and responsible officer.

While granting four weeks' time to the Centre for filing a proper affidavit, the SC mulled the idea of completely banning clinical trials until the government apprised it of putting in place regulatory framework.

"Why should we not pass an interim restraint order? You have to ultimately protect the life of the citizens. Deaths must be arrested arising out of these trials and the situation has to be controlled. How does one justify clinical trials that are not for use to this country? Uncontrolled clinical trial is creating havoc in country," said the court.

When informed by the government counsel about a committee looking into all the aspects of clinical trials, the Bench said: "You can get back to us with the committee's report but people who have lost their lives will not get it back. You have said that 80 deaths have occurred. Every life is precious for us and we cannot wait for thousands of people to die. A person may be ailing but it does not mean that he deserves to die because of an unwarranted clinical trial."

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