No drug trials sans monitoring mechanism: Apex court
Taking a serious view of alleged use of human beings as guinea pigs for clinical trials by drug companies, the Supreme Court today asked the Centre and various states governments to reply to the allegation.
A Bench of justices R.M. Lodha and A.R. Dave also directed the Union Government to come out with details of the deaths, if any, and the side effects and compensation, if any, paid to the victims or their family members.
The apex court’s direction came during the hearing of a public interest litigation petition, filed by NGO Swasthya Adhikar Manch, alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests.
“We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith.
It must suffice, we are very serious about it,” the apex court told Additional Solicitor General Siddharth Luthra.
The Bench while expressing its serious concern, however, refrained from passing any blanket ban on the trials and instead sought a comprehensive reply from the Centre on the four issues.
The issues included number of applications received by the Union Government for clinical trials between January 1, 2005 and June 30, 2012.
The Bench secondly wanted to know “the number of deaths, if any, suffered by subjects of clinical trials and if yes, the number and nature of deaths.”
Third, the Bench sought to know “the serious side effects, if any, suffered by subjects of clinical trial and if yes, the number of such side effects and nature of side effects.”
The Bench also asked if any compensation was paid to the subjects who suffered side effects or to the family of subjects who died.
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