Supreme Court issues notices on unethical drug trials

The Supreme Court of India has issued notices to the Centre and the Madhya Pradesh government in connection with clinical drug trials being conducted across India. This follows a public interest petition filed by an Indore based non-profit, seeking the court's intervention to put a stop to unethical clinical trials. Reports of unethical trials conducted on children and mentally challenged patients in Madhya Pradesh surfaced recently in various media reports. The petition filed by Swasthya Adhikar Manch was admitted by the court on February 6.

The bench comprising R M Lodha and H L Gokhale issued notices to the Ministry of Health and Family Welfare, the Indian Council of Medical Research (ICMR), the Drugs Controller General of India (DCGI), the Medical Council of India (MCI) and the State of Madhya Pradesh. They have been asked to review and file replies on the existing rules governing drug trials and the desired amendments within six weeks.

Advocate for petitioner Sanjay Parekh argued in court that the country is increasingly witnessing many illegal and unethical drug trials. According to the petitioner, a total of 1,727 deaths occurred between  2007 and 2010. “We have accessed information through RTI. The replies given by the (Union) health minister Ghulam Nabi Azad in Rajya Sabha show that 3,138 trials were conducted between 2006 and 2009. Around 806 trials were conducted from January 2010 to December 2010 and 928 in the year 2011,” says Amulya Nidhi, member of Swasthya Adhikar Manch. 

“We have also asked the court to examine the present legal set up and guidelines concerning clinical trials on adults, children and even mentally ill patients and the compensation given to them in the country,” he adds.  The petitioner has also sought that regulations be imposed on the contract research organisations (CROs) that recruits volunteers for the drug trials and are operating in an unregulated and uncontrolled fashion.

The petition also highlights irregularities in drug trials like the principal investigator of a clinical trial also being a member of ethical committee in violation of the ethics guidelines, the inactive role played by ethics committees and no compensation being paid to patients for adverse effects. Down To Earth in its cover article   had extensively reported unethical drug trials taking place in India. The article has been used as a reference in the petition.