Centre restrained from allowing clinical drug trials

Supreme Court orders health ministry to consult states and evolve a regulatory framework first

By Kundan Pandey
Published: Monday 17 August 2015

The Supreme Court on Monday restrained the Central government from giving permission for clinical trials of new drugs without putting in place a proper mechanism to regulate such trials in the country. The bench headed by Justice R M Lodha stressed on the setting up of a proper mechanism for monitoring clinical trials in the country and also asked the government not to allow trials for untested medicines. The Centre informed the court that it will not allow clinical trials of 162 drugs earlier permitted by it.

The court while hearing a petition filed by Indore-based non-profit, Swasthya Adhikar Manch (SAM) Central government to evolve a framework of mechanism for conducting and monitoring clinicals trial in the country, informed Amulya Nidhi, co-convener of SAM.
In the last hearing, the court had directed secretary of Union Ministry of Health and family Welfare (MoHFW) to hold a meeting of chief secretaries and health secretaries of all states to discuss the legal framework for strengthening the regulation of clinical trials in the country. The secretary of MoHFW had also been to take opinion of petitioners, National Human Rights Commission and NGOs. The court has given 10 weeks time to MOHFW to prepare legal framework after the discussions.

Counsel for petitioner Sanjay Parikh argued that hundreds of people have died during clinical drug trials because many new chemical entities are being tested without proper regulations being in place.
In an affidavit, the Central government had admitted that more than 2,600 people lost their lives during clinical trials for 475 new drugs between 2005 and 2012. Nidhi informed that the government had admitted in the affidavit that serious adverse events of deaths during the clinical trials were 2,644 but only 80 deaths were attributed to the said clinical trials.

He also informed that a total 259 applications regarding new chemical entities have been recommended for approval from July 3 to August 31.  Out of these, 162 have been approved by the Drugs Controller General of India (DGCI). The next hearing of the case is scheduled after two weeks.

Recently, the expert committee headed by Ranjit Roy Choudhury, advisor to department of health and family welfare, had proposed major changes in existing guidelines for clinical trials in the country. The committee was set up by the Central government. The committee recommended that clinical drug trials should be held only at centres that are accredited for the purpose.


Report of the Prof. Ranjit Roy Chaudhury Expert Committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs

Supreme Court order dated 03/01/2013 on clinical trials

What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies
National Consultation on Regulation of Drug Trials
Clinical trials and healthcare regulation in India

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