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India Takes Steps to Increase Clinical Trials

Volume 14, No. 2  March 2006

Plans to create a clinical trial registry and conduct audits of some clinical trials have been announced by the Indian government to prepare for an expected increase in clinical trials in that country, according to the British Medical Journal (331-1044).

About 100 clinical trials were being conducted in India in 2005. India earned an estimated $17 million in 2003 from clinical trials.

The registry of clinical trials conducted in India will be created by the Indian Council of Medical Research (ICMR). The audits will be conducted by inspectors being trained by the health ministry to ensure compliance with ethical guidelines and good clinical practice.

The ICMR drafted ethical guidelines for biomedical research on human subjects in 2000 but legislation to enforce those guidelines and impose penalties on violators is still pending, according to the ICMR deputy director general.. See guidelines at http://ori.hhs.gov/international/websites/index.shtml

Attendees at a conference called to consider India’s capacity for clinical trials said the country would have to strengthen its regulatory mechanisms and infrastructure, ensure the protection of human subjects, increase human resources available to conduct clinical trials, and monitor the behavior of doctors.