India loses its attraction for pharma clinical trials, as domestic regulations tighten

Considered a global clinical trial hub three years ago, India has suffered a series of setbacks, with its apex court, the Supreme Court in early 2013 revoking the Ministry of Health’s right to clear clinical trials in the country, reports The Pharma Letter’s Indian correspondent.

New regulations and problematic clauses that followed have sounded the death knell on trials, with the number of clinical trials slipping to 19 in 2013, as compared to 500 in 2011. It is not just clinical trials that have been brought to a grounding halt, she says. The move has also affected the number of new drug discoveries in India.

Y K Gupta, head of the Department of Pharmacology at the All India Institute of Medical Sciences (AIIMS) in New Delhi said: “Only 23 new drugs were approved in India last year, registering an eleven-fold drop as compared to 2008, when 270 drugs received approval. The stringent approval process has also pushed India to the second slot after China for clinical trials.''