Pharmacovigilance & Clinical Trials

Biography

Biography: Swadhin Mondal

Abstract

India has emerged as a popular destination of global clinical trials (CTs). However, the processes of CT by the drug companies have been raising some critical issues on its progress, prospect and the process of clinical research as a human subject. This paper is examining such aspects of clinical research by reviewing existing literature as well as various sources of evidences. The study shows that India is the most potential destination for CTs. Over the past few years’ industry became most cost efficient destination and growing faster, but recently the industry is facing serious challenges due to massive government intervention to control the operation. There was a major collapse during 2013 onward only because of some incidence of death occurred due to trials and it consequences by the government. Due to regulation, many companies have postponed trials; many have stopped operation permanently or planning to move other destination for trials. India has greater comparative advantage of cost minimization, large patient’s pool and availability of skilled professionals. The only challenge facing by the industry is over regulation by the government. Thus India could be the most favourable destination if government create an industry-friendly environment by relaxing some of the regulations and encourage CRO to do trials without violating humanitarian ethics and other social norms.