@article{Kulshreshtha_Venkatesh_Shrisha_Kumar_Kumar_2015, title={CLINICAL TRIAL IN INDIA: RISE AND FALL}, volume={3}, url={https://ijdra.com/index.php/journal/article/view/11}, DOI={10.22270/ijdra.v3i1.11}, abstractNote={<p>Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices through<br>clinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potential<br>treatments in human volunteers to see whether they should be approved for wider use in the general population. A<br>treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stood<br>as a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the decline<br>of clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filing<br>process, the amendments made in its regulations and the challenges faced by Indian clinical trial industry.<br>&nbsp;</p&gt;}, number={1}, journal={International Journal of Drug Regulatory Affairs}, author={Kulshreshtha, Chitral and Venkatesh, M P and Shrisha, K and Kumar, Pramod T.M. and Kumar, Pramod T.M.}, year={2015}, month={Mar.}, pages={1-13} }