Human trial of drugs: SC seeks govts' replies

Taking a serious view of alleged use of human beings as guinea pigs for clinical trials by drug companies, the Supreme Court on Monday 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."

Thirdly, 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.

Appearing for the NGO, counsel Sanjay Parekh alleged the clinical trials by several pharmaceutical companies were going on indiscriminately in various states, senior counsel Dushyant Dave for the Madhya Pradesh government said the states cannot be faulted for the tests.

He argued that the permissions for trials were granted by the Central government without consulting the states.

The argument, however, did not impress the bench which pointed out that the said clinical trials were conducted in state governments' hospitals whose employees and doctors are under the control of the respective state governments.

It then proceeded to issue notices to all the states, through their chief secretaries, for their responses and posted the matter for further hearing after eight weeks.

The notice was not issued to the Madhya Pradesh government as it is a party before the court.

Detailing several cases of alleged illegal drug trials in Indore, the NGO has said, in its petition, "Over 3,300 patients were used for the tests. Approximately 15 government doctors were involved. About 40 private doctors in 10 private hospitals were involved.

"Clinical trials were conducted on 233 mentally-ill patients, 1,833 children in the age group of one day to 15 years. . . Approximately Rs. 5.5 crore (Rs 55 million) were paid to the government doctors alone.

In 2008, there were 288 deaths, in 2009, there were 637 deaths, and in 2010, there were 597 deaths," it has alleged.

It claimed there was lack of transparency in clinical trials as the subjects were not aware of their rights.

It said majority of people on whom the tests were performed were poor and illiterate, came from marginalized communities and suffered serious adverse effects.