CLINICAL TRIAL IN INDIA: RISE AND FALL
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 1
Abstract
Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices through clinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stood as a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the decline of clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filing process, the amendments made in its regulations and the challenges faced by Indian clinical trial industry.
Authors and Affiliations
Chitral Kulshreshtha, Venkatesh M P, Shrisha K, Pramod Kumar T M
Keywords
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- EP ID EP338314
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