Recent Amendments in Handling Clinical Trials in India (Schedule Y)

Abstract

India has been considered as a hub for conducting various multi centre trials, the Central Drugs Standard Control Organization (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. Updating our knowledge about these is of utmost importance in today turbulent scenario that prevails in the pharmaceutical industry. The path was smooth until 2011, when a dramatic drop in conducting and delivering the international Randomized controlled trials (RCT) outsourced to India was noticed. According to certain calculations, this drop is up to 50%. At the same time international outsourcing of RCTs to China, Russia and Philippines has increased. In a pursuit to find an answer to this drastic decline, the conduct of trials, ethics, regulatory environment and the quality of data, all are challenged. This review focuses on the changes in regulatory aspects introduced subsequently and their impact on clinical trials in India. Some proposals of amendment in D and C rules have been approved by Drug Technical Advisory Board (DTAB).