India: 10 die per week in drug trials

The Indian government plans to investigate the mortality rate in clinical trials held in India, after a World Health Organization study revealed that 10 people a week died during drug testing between 2008 and 2011.

Mortality rates in clinical trials in India have remained consistently high despite intermittent public outcry, the Indian Express reported.

While 438 deaths were reported in 2011, 668 died in 2010, 637 in 2009 and 228 in 2008, as per WHO’s international clinical trial database.

That said, the number of trials conducted in India remains low — at just 1.5 percent of the world total — despite past claims that India is emerging as a global hub for such drug research.

Moreover, the clinical trial registry of India also shows that only 25 percent of all trials in India are global trials. The others are for indigenous products, the paper said.

As GlobalPost reported earlier, thousands of institutions are involved in drug testing, not only in major cities but in small provincial towns across India, according to Amar Jesani of the Indian Journal of Medical Ethics.

But while companies are required to register the trials themselves, there is no comparable system for registering the ethics committees charged with evaluating their research protocols.

Only a handful of the hundreds of ethics committees have any official accreditation, which means that most of the supposed watchdogs have never been evaluated or audited by any outside agency themselves. Most of them do not publish any details about the number of clinical trials they have evaluated or what methods are used to monitor drug testing.