Industry Sponsored Trials Fall Sharply In Challenging Indian Environment

The rosy view of India as a location for relatively low-cost clinical trials with a readily available, treatment-naïve patient population became shaded over the past five years by an untenable time to approval. With the prolonged online review process, combined with increased liability for sponsors and other trial-related restrictions by the Indian government, it is not surprising that India became a less attractive clinical trial location to pharma. (Also see "NIH confirms cut-back in Indian trials but large sponsors hope for reform" - Scrip, 18 July, 2013.) Taking a look in Trialtrove, we examined industry-sponsored study starts in India in the aftermath of these regulations, drilling down to explore the effect across major therapeutic areas, sponsors and diseases.

Multiple factors have contributed to an increased approval time in India during the last 5 years. The country transitioned to a mandatory, online filing process in 2009 (IPP clin trials reg india.pdf), extending review completion to as long as 9 months by 2012. (Also see "China now leads India 2:1 in clinical trials " - Scrip, 3 July, 2012.) In 2013, the Indian government also shifted greater responsibility to sponsors for the liability in the running of trials and implemented restrictions regarding ongoing trial numbers for each investigator and the site size required for trials