Bench issues notice to all States also

The Supreme Court on Monday expressed serious concern over clinical trial of drugs on human beings and issued notice to all States through their Chief Secretaries for their response.

Hearing a petition filed by the Swasthya Adhikar Manch, highlighting the menace, a Bench of Justices R.M. Lodha and Anil R. Dave also wanted the Centre to furnish details of deaths, if any, of the subjects of clinical trials.

Justice Lodha told Additional Solicitor General Siddharth Luthra, appearing for the Centre: “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. We want a comprehensive reply from you on four issues.”

The response must contain particulars of how many applications were received by the Union government for clinical trials between January 1, 2005 and June 30, 2012; the number of deaths, if any, and nature of deaths; serious side-effects, and if ‘yes’, the number and nature of such cases; and compensation, if any, was paid to the subjects who suffered side-effects or to the families of subjects who died.

The matter will be listed after eight weeks.

Appearing for the Indore-based NGO, counsel Sanjay Parekh alleged that clinical trials by several pharmaceutical companies were going on indiscriminately in various States.

Senior counsel for Madhya Pradesh Dushyant Dave said the States could not be faulted for, permission for trials was granted by the Centre without consulting them.

Justice Lodha told counsel: “Clinical trials were conducted in State government hospitals whose employees and doctors are under the control of the respective State governments.”

The court had in March issued notice to the Centre and Madhya Pradesh on the writ petition, which alleged that illegal trials of untested drugs were being conducted on adults, children and even mentally ill persons in various States.