Update: No New Clinical Trials in India

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

On September 30, 2013, the Supreme Court of India (the Court) ordered the Indian Ministry of Health not to approve any new clinical trials until new mechanisms are in place for stricter monitoring of clinical trials, to ensure greater protection of human subjects participating in those trials. Furthermore, the Ministry of Health will not permit 162 existing clinical trials approved earlier this year to continue until the Court reaches a decision on October 21st to determine if these clinical trials should continue. On December 16th, the Court will hear recommendations from experts in the Indian government, patient advocates, and industry regarding monitoring of clinical trials.

The Court’s directive resulted from a Public Interest Litigation (PIL) petition filed on behalf of the non-governmental organization Swasthya Adhikar Manch (SAM), seeking to halt clinical trials in India for new products that will not be sold or marketed in India. SAM alleged that weak regulatory controls on the conduct of clinical trials combined with poor enforcement of such controls contributed to an unacceptable number of deaths and adverse events in the clinical trials conducted in the country. Over the summer, the Court agreed to halt clinical trials until a new regulatory scheme is established to provide greater clinical trial oversight.

Until the Ministry of Health’s New Drug Advisory Committee can establish new regulations and oversight measures, clinical trials in India will be largely halted. Sponsors and industry followers expected the September 30th decision to shed more clarity on the issue, however, it appears that this situation is in its early stages. Considering the expected delays while the Indian government develops oversight mechanisms, Sponsors should consider alternate sites until further guidance is available.

Contact: John Williford, Esq. (703) 734-0484 Ext. 104 jwilliford@cttg-law.com

*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.

The information contained herein is for informational and educational purposes only and does not constitute legal advice, substitute for legal counsel, or establish an attorney-client relationship. You should not act or rely on any information contained in this website without first seeking the advice of an attorney.