The Madhya Pradesh government on Monday told the Supreme Court clinical trials by drug companies on humans in the state were done without its knowledge as they were conducted with the Centre’s approval.
Responding to public interest litigation (PIL), alleging the trials were done in violation of the prescribed procedure, the state admitted that some of the doctors conducting the trials worked at government hospitals and were currently facing disciplinary proceedings.
Senior advocate Dushyant Dave and counsel Vibha Dutt Makhija also claimed that despite state government’s persistent request to the Director General of Health Services, ministry of health, the latter failed to provide any information regarding trials in the state.
“Unfortunately maximum cases of clinical trials have been reported from MP. But, the Centre is responsible for it as such trials are permitted under the Drugs and Cosmetics Act by the DGCI. States have no role in it” Dave told the court.
Taking a serious view of the allegations by an NGO — Swasthya Adhikar Manch, a bench of Justice RM Lodha and Justice AR Dave sought details of clinical trials conducted in the country since January 1, 2005, of the deaths and side-effects, if any, due to such trials.
The court also wants to know whether compensation has been paid to those who suffered set-backs and to the family of those who died during the trials. It also expanded the scope of the PIL and issued notices to all states for their response.
In a detailed affidavit, the MP government claimed it suspended clinical trial in the state in August 2010, on learning about it through media reports.
The state added it had already initiated disciplinary inquiries regarding financial irregularities and foreign trips without permission against the erring government doctors. With regard to private practitioners, the state had lodged complaints with the Medical Council of India.