India’s Ministry of Health Issues Mass Approval of Clinical Trials

Since India’s Supreme Court transferred the power to regulate clinical trials from the Drugs Controller General of India (DCGI) to the Ministry of Health (MOH) on January 3, 2013, just 12 clinical trials had been approved for the first six months of 2013, compared to 262 clinical trial approvals for all of 2012.

This changed at the beginning of July, when the MOH issued a mass approval of 50 clinical trials for new drug approvals, new chemical entities, experimental drugs, and fixed dose combinations.

The reasons behind the delay are complex. After the Supreme Court ruling — which came in response to a government report that put India’s clinical trial deaths in the thousands — the MOH has “played it safe” in issuing clinical trial approvals.

The dramatic decrease in approvals comes at a time when India was already losing its attractiveness as a location for clinical trials. Canada and Southeast Asian countries like Malaysia are becoming much more attractive destinations, due to higher quality standards, clearer regulations and shorter approval times. At the beginning of July, the US National Institutes of Health (NIH) announced that it was cancelling 40 clinical trials already underway in India.

In India, the number of clinical trials has dropped dramatically from its peak of 500 in 2010. There were just 325 approvals issued in 2011, and 262 approvals issued in 2012, according to The Hindu. Clinical trial executives estimate a loss of up to $200 million for the $500 million industry this year.