The investigational new drug (IND) filing process in the Indian regulatory system needs to change drastically to meet competitive challenges from China and Eastern Europe geographies that has made a mark in the low-end bio-equivalence testing for generic drugs, and western regulators are accepting Indian dossiers. It is, however, the more skill-based and high-tech process of doing phase I to III trials which are proving to be much more difficult.In the past, Phase I trials were allowed only for Indian discovery molecules. This was done to stop Indians becoming “guinea pigs” for foreign companies. Phase II and onwards was allowed for other MNCs wanting to do a clinical study in India. Foreign companies did begin to do Phase 3 trials in India where this country became a part of the worldwide trials. Phase III and the other bio-equivalence work formed the bulk of the revenue of most of the CROs in India. India proved to be adept at following worldwide GCP (Good Clinical Practice) methods and many scientists from abroad returned home to provide international methodology.

Source: ET