Recent changes in regulatory aspect of clinical trials in India

Dr. Yashasvi Suvarna, Dr.Rathai Rajagopalan | World Journal of Pharmacy and Pharmaceutical Sciences | Vol 4 Issue 7 | 2015


India has been a hub for conducting various multi centre trials. The Central Drugs Standard Control Organisation (CDSCO), headed by the Drug Controller General of India(DCGI), lays down the regulations for the conduct of clinical trials in India. This trend has but changed from 2011 when most of the trials are being outsourced to other countries like China and Philippines. The conduct of trials, regulations in India and quality of data generated may be the cause for this development. There is a paucity of reviews which sum up the changes in the regulations of clinical trials introduced from then on. Updating our knowledge about these is of utmost importance in today‗s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review provides an insight into the recent changes with respect to the regulations of clinical trials and its impact on the clinical research industry in India.

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