Supreme Court of India Orders New Clinical Trial Regulations

By: John Williford, Esq. Clinical Technology Transfer Group, PLLC

Sponsors may have more clarity next week on the regulatory environment for conducting clinical trials in India. The Supreme Court of India (the Court) gave the Indian Ministry of Health until September 24, 2013 to propose new regulations governing the conduct of clinical trials that will ensure the safety of patients and encourage the conduct of trials in India.

The Court’s directive is the result of a Public Interest Litigation (PIL) petition filed on behalf of the non-governmental organization Swasthya Adhikar Manch (SAM), which sought to halt the conduct of clinical trials in India for new products that will not be sold or marketed in India. SAM alleged in the petition that weak regulatory controls on the conduct of clinical trials combined with poor enforcement of such controls has contributed to an unacceptable number of deaths and adverse events in the clinical trials conducted in the country.

This directive is just the latest action in a series of efforts to revise the laws governing the conduct of clinical trials in India. Earlier this year India passed new regulations which require Study Sponsors to provide free medical management to subjects injured in a clinical trial for as long as required. Additionally, the Drugs Controller General of India recently made central registration of all ethics committees mandatory which has caused significant delays due to understaffing.

All of these actions are the result of concerns that the current regulations do not adequately protect human subjects in India. Over the past decade, India has seen a drastic increase in the number of domestic clinical trials, largely due to the size of its population and comparatively low administrative costs. Court documents allege that over 2,262 clinical trial participants in India died in the past the past five years, as a result of the trials. The concern over these deaths and other injuries, groups such as SAM have been seeking an overhaul of the clinical trial regulations and requesting probes relating to any governmental corruption relating to the approval or oversight of clinical trials.

But the combined actions and the lack of clarity on how they will be enforced have caused significant uncertainty for Study Sponsors. This uncertainty has caused some Study Sponsors, including the National Institutes of Health in the United States, to suspend or terminate ongoing studies. Study Sponsors and Contract Research Organizations (CROs) should consider carefully whether conducting clinical trials in India poses too much risk at this time. While Court’s directive appears to be a positive step it may be some time before Sponsors have the clarity they need on the risks associated with conducting trials in India.

Contact: John Williford, Esq. (703) 734-0484 Ext. 104

*This CTTG-Global Client Alert is brought to you by the Clinical Technology Transfer Group (CTTG), based in Mclean, VA through its strategic alliance with EMMEPlus, based in Bergamo, Italy. With special thanks to Gautam Khurana, Managing Partner of India Law Offices in New Delhi for his assistance.

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