The process of approval of new drugs and conduct of clinical trials has been rationalized by the Government with a view to ensure a careful assessment of the risk versus benefit to the patients, innovation vis-à-vis existing therapeutic options and unmet medical needs in the country. These criteria have been made an integral part of the approval process. Besides, a module for online submission of clinical trial applications has been operationalized. Further, the pool of Subject Experts has been increased manifold and time-lines fixed for all activities. At the same time, adequate measures have been put in place to ensure the safety and welfare of patients /clinical trial subjects.