The Supreme Court of India has asked the Union Government to submit details of the number of deaths and severe adverse effects (SAEs) caused to people during the clinical trials.

A bench headed by Justice R M Lodha issued the order on Monday while hearing a petition by NGO Swastha Adhikar Manch seeking directions for regulation of clinical trials of new drugs and chemical entities. The Bench also expressed concern on the matter saying that 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 clinical 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.

The pharmaceutical companies must specify whether the risk involved in testing the new formulations on human beings is justified by the benefits expected from the exercise, whether there are unmet needs for the drug in this country necessitating the innovation and whether safer are methods available, he court stated.