Come out with rules to regulate clinical drug trials on humans: SC to govt

The Supreme Court Wednesday directed the Centre to come out with rules to regulate clinical drug trials on humans by pharmaceutical firms, saying it would have a "serious impact" on the health of the people.

The Centre told the apex court that it has issued draft rules on clinical trials in February this year, which includes a compensation ranging from Rs 5-75 lakh to the victims of such trial, and 45 days had been given for objections and suggestions on it.

A bench of Justices Madan B Lokur and Deepak Gupta told the petitioners, who have alleged that large-scale clinical drug trials were being conducted on humans across India by various pharmaceutical firms which has led to several deaths, to give their objections and suggestions on the draft rules to the government so that these could be considered.

The petitioners have alleged that clinical trials by several pharmaceutical firms were going on indiscriminately in several states across the country.

The Centre's counsel told the court that they would issue notice inviting objections and suggestions to the draft rules and those who file them would be heard.

When the counsel said that around 100 persons have given their objections and suggestions on the draft rules, the bench observed, "It will have a serious impact on the health of people of this country. You call these people and talk to them".

Advocate Sanjay Parikh, representing one of the petitioners, told the bench that the rules have to be framed to regulate the issue of clinical drug trial as people were being treated as "subjects" during the process.

"Nobody looks into the serious question of deaths because of these trials," he said adding that earlier, clinical trials were conducted on persons without they being informed.

To this, the bench observed "Ultimately, the regulation and implementation has to be done by the Union of India and the states. We can go on passing directions but it will be of no help".

Senior advocate Colin Gonsalves, appearing for another petitioner, said there was blatant violation of the law by the state governments and a number of deaths have taken place due to such clinical trials. He also referred to reports of the Parliamentary Standing Committee in 2012 and 2013 on the issue.

Gonsalves said multinational companies have been excluded from paying compensation to the victims of clinical trials and those engaged as contractors of these firms have been made liable to pay the damages.

He said there was no punishment for such illegalities and even private hospitals were authorised to set up their ethics committees to oversee clinical trials.

The bench told the petitioners that they should give their objections or suggestions on the draft rules so that the government could consider them.

"At least to begin the exercise. They (government) have done something. Whatever you want to say, you tell them," the bench said.