TY - JOUR AU - Chitral Kulshreshtha AU - M P Venkatesh AU - K Shrisha AU - Pramod T.M. Kumar AU - Pramod T.M. Kumar PY - 2015/03/06 Y2 - 2024/03/29 TI - CLINICAL TRIAL IN INDIA: RISE AND FALL JF - International Journal of Drug Regulatory Affairs JA - Int J Drug Reg Affairs VL - 3 IS - 1 SE - Review DO - 10.22270/ijdra.v3i1.11 UR - https://ijdra.com/index.php/journal/article/view/11 AB - Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices throughclinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potentialtreatments in human volunteers to see whether they should be approved for wider use in the general population. Atreatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stoodas a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the declineof clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filingprocess, the amendments made in its regulations and the challenges faced by Indian clinical trial industry.  ER -