Supreme Court Seeks Report On Gaps In Drug Trial Rules; PIL Highlights Ethics Concerns In Bhopal & Indore

Bhopal (Madhya Pradesh): The Supreme Court on Tuesday directed a petitioner to file a composite report regarding gaps in the Central Government drug trial rules.

A division bench of Justice PS Narasimha and Justice Alok Aradhe was hearing a Public Interest Litigation (PIL) filed by the NGO Swasthya Adhikar Manch in 2012, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms. The apex court has fixed the plea for consideration on Apr 27.

Senior Advocate Sanjay Parikh, appearing for the NGO, said there is a lack of a proper procedure for the enrolment of subjects for clinical trials of drugs. He stated that he is not challenging the New Drugs and Clinical Trials (Amendment) Rules but is pointing out several gaps that need to be addressed.

Swasthya Adhikar Manch (SAM) national convenor Amulya Nidhi said that 22 people had died in Bhopal and 33 in Indore following drug trials. While the Central Government has trial rules, there are many gaps, and the court has asked for a composite report on these deficiencies, Nidhi added.

Nidhi highlighted that the Economic Offences Wing (EOW) had brought out a report on unethical human trials of drugs in the state, noting: EOW said these doctors made a neat sum of Rs 5.10 crore by performing a series of 76 clinical trials on 3,307 innocent people at the departments of paediatrics at MGM College and Chacha Nehru Bal Chikitsalaya Evam Anusandhan Kendra, and the department of medicine and neurology at MY Hospital, Indore.