New Delhi, January 3 
The Supreme Court today directed the government to wake up from the “deep slumber” and prevent multinational drug companies from using unsuspecting poor patients as “guinea pigs” for clinical trials of new medicines to check their efficacy and side effects prior to marketing them. 

Pointing out that a Parliamentary committee had noted that the Central Drugs Standard Control Organisation under the Directorate General of Health Services (DGHS) had failed to monitor the clinical trials to ensure that these were conducted ethically, a Bench comprising Justices RM Lodha and Anil R Dave directed the government to strip the DGHS of its power.

At this, Additional Solicitor General Sidharth Luthra said the government was ready to entrust the responsibility of monitoring the trials with the Union Health Secretary. The Bench recorded his assurance, clarifying that such trials should be conducted under the direct supervision of the Secretary. 

The Bench was hearing a PIL filed by Swasthya Adhikar Manch, an Indore-based NGO, contending that as many as 560 of the 12,000 patients subjected to clinical trials had died as a result of  the side effects. Disputing this, the ASG put the casualties at 87. Clarifying that the focus was not on the number of casualties, the Bench wanted to know as to whether the trials were essential if these were not of any use to India. 

Rejecting an affidavit filed by a Deputy Director in the DGHS in response to its notice on the PIL, the Bench made it clear that the Health Secretary or the DGHS Director General should have filed the document as directed by it. A fresh affidavit should be filed by the Secretary within four weeks.

When the ASG clarified that only patients suffering from serious ailments were being subjected to trials, the Bench said “every human life is precious,” healthy or otherwise and the companies had no right to test their medicines even on sick people.

According to the PIL, mentally ill patients and about 1,800 children, mainly from illiterate and marginalised communities, were involved in the trials.