chapter  9
4 Pages

Drug testing in India

ByNICHOLASJ .C . SANTOS

A country that emerged as the fastest growing destination for clinical drug testing during the fi rst decade of the new millennium was India.2 Partly responsible for this development was the enactment of a new ruling in 2005 that permitted foreign pharmaceutical companies to conduct phase II and III trials of new drugs in India concurrently with trials of the same phase conducted in other countries.3 Previously, phase II and III trials were only permitted in India after they had been already completed in another country. Phase II and III clinical trials both involve testing on human volunteers to ensure suitability for sale. Phase II trials focus on dosage levels and overall effi cacy, while phase III trials on regulatory approval. Phase III trials in particular are considered expensive, time-consuming, and very diffi cult to run.