India's Biotech Aspirations

Pushing clinical trial capacity

The Drug Controller-General of India recently announced that new regulations for reviewing applications to test investigational drugs will be released by the end of November. The regulatory regime, modeled on World Health Organization and International Conference on Harmonisation guidelines, is intended to increase the number and scope of international trials conducted in India.

In addition to conducting bioequivalence trials of approved products and studies involving new indications for drugs approved in developed countries, companies have begun selecting