Clinical research has grown exponentially over the past decade in India
because of cost advantage, treatment naïve patient, qualified doctors
conversant in English etc. India was the second most preferred country
to conduct clinical trials outside the US in 2009. However, recent years
have witnessed a decline in number of trials in India (529 in 2010; 253
in 2012). The number of drugs entering the Indian markets had been
gradually reducing even before the current slump in clinical research
activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This
necessitates a relook on the strategy so as to optimise clinical
research in Indian context. The problems and possibilities around the
clinical research arena can be broadly grouped as capacity building
issues and ethico – regulatory ones.
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