INDIA PLANS CLINICAL TRIALS BODY STYLED ON US FDA

Amid plans to streamline its healthcare regulation, India could create a new agency to monitor clinical trials, with standards modelled along US FDA lines. The government's reform agenda could improve the bureaucratic nightmare presented by India's existing plethora of overlapping agencies.

Recent reports have pointed to the possibility of a bilateral co-operation protocol, potentially bringing a better system for approving drugs for the U.S. market that have been tested in India. However, observers comment that US FDA approval for trial data is never automatic, and that standards will have to improve if India is to gain a larger slice of the increasingly competitive global clinical trials market.

With precisely this objective in mind, India issued new regulations on clinical trials in January. Rebuffing popular fears that Western drug firms would exploit Indian volunteers as "guinea pigs," the rules represent a major step forward.

Early-stage discovery work is now a possibility in India, as previously only Phase III and bioequivalence studies were permitted. Notably, the revisions also allow for the export of human tissue samples, potentially a major boost to biotechnology companies seeking to outsource some of their clinical trials in the country.