Supreme Court orders government to put clinical trail mechanism in place

Supreme Court orders government to put clinical trail mechanism in placeIndia apex court, the Supreme Court on Thursday criticized the central government for failing to check the number of deaths and severe effects of clinical trials in the country.

The court ordered the Union health secretary to oversee implementation of the mechanism for supervision and security for clinical trials of new drugs on human beings. The court referred to a report by a parliamentary committee that said that foreign pharmaceutical multinational companies are involved in clinical trials of new drugs in the country.

A bench of Justices R M Lodha and A R Dave criticized the government for its inaction over the issue and pointed out the need for a detailed review of the present mechanism for supervising clinical trials of new drugs in India. The court expressed concern and frustration over the death of 80 people during such trials between 2005 and 2012.

The court just stopped short of banning the clinical trials of new drugs on humans. Additional solicitor general Siddharth Luthra promised that the Union health secretary will monitor the implementation of the new and more stringent mechanism. The court accepted his suggestion and ordered the government to comply.

The bench said, "We do not know what sort of racket the big companies are indulging in. That's why we are concerned by the loss of lives. Even the parliamentary committee says children and illiterate citizens are being used as guinea pigs by foreign companies."