As part of our series of white papers tracking clinical trials activity in emerging markets, GlobalData covered India in November 2016. This country experienced a prominent slowdown in clinical trial activity due to public ethical concerns and regulatory changes between 2010 and 2013, following the rapid growth of previous years.

Following fast growth in the number of trials between 2006 and 2010, serious ethical concerns and the ensuing regulatory changes caused the number of clinical trials to invert their trend in 2012 (see Figure 1). The number dropped suddenly in 2013 and has not recovered fully to date.

Between 2010 and 2012, non-governmental organizations (NGOs) published several complaints and public-interest litigation petitions regarding the unethical promotion of clinical trials in India, the widespread violation of rules of informed consent, and the need to investigate deaths and adverse events. In March 2013 the Drugs Controller General of India (DCGI) set up an expert committee to examine reports of deaths in clinical trials and major changes were proposed. The US National Institute of Health (NIH) suspended 40 clinical trials in July 2013 and India’s Supreme Court suspended all clinical trials of new drugs in September 2013. By 2015, a new three-tier system for trial approval was put in place.

Industry trials decreasing faster than other trials

This decreasing trend appears to have predominantly impacted industry-sponsored trials, as they decreased at a much higher rate every year from 2010 until 2013, showing only a marginal increase up to 2015 and then another fall in 2016. Meanwhile, the number of non-industry-led trials continued to increase until 2012, then showed a moderate decrease up to 2015, and a more pronounced slow-down in 2016.

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