Clinical trials: SC asks details on deaths from Centre

The Supreme Court today directed the Centre to provide details on the number of deaths and severe adverse effects caused to people who were subjected to clinical trials.
A bench headed by Justice R M Lodha expressed concern over the issue saying the government must take a balanced approach so that development in the areas of research is not hampered and at the same time people's lives are also protected.
"We will have to take a balanced approach. Nothing should be done to stop development in the area of research of drugs and at the same time life of people subjected to trial has to be protected," the bench said.

The court passed the order after it found that there were discrepancies in the numbers given by the petitioner NGO and the government.
While the NGO claimed that in 2012 and 2013, there were around 4,000 cases of severe adverse effects of drugs trial, including deaths, the government claimed the figure stood at 506, with 89 cases of deaths.
The court also said that compensation was granted only to kin of those who died during the trials and asked why it should not be paid to those who were severely effected but alive.

It also directed the Centre to file an affidavit on what steps it was taking for making provision of payment of compensation to people who are affected in clinical trial.

The court had earlier directed the government to ensure audio-visual recording of consent of clinical trial subjects.
The Supreme Court is hearing a PIL filed by Swastha Adhikar Manch seeking directions for regulation of clinical trials of new drugs and chemical entities.