Current regulations for clinical trials
Keywords:Clinical Trials, Regulation, TRIPS, WTO
The Clinical Trials Regulation aims to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety. Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products. Clinical trials are the key tools in new drug evaluation. India has signed the trade related intellectual property rights (TRIPS) agreement as a part of the WTO regulations to gearing up to attract more and more researchers from around the world to conduct clinical trails in India. .For new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as per the requirement.