Impact of new regulations on clinical trials in India.

ABSTRACT

Background: India is one of the major destination for conducting clinical trials. The Drug Controller General of India (DCGI) is the governing body responsible for all pharmaceutical-research and regulatory issues in India. While conducting clinical trials in India, regulations have come to ensure safety and wellbeing of the study subjects in the trial. The present study was planned to see the number of trials approved by DCGI and their trend over the last 8 years in view of new regulatory guidelines. Methods: Data obtained from website of the Regulatory Authority i.e. Central Drugs Standard Control Organization (CDSCO) regarding DGCI Approval of clinical trials from 2007 till 2014 are noted for analysis. Results: Total 1799 Trials Approved. 2007 had lowest approvals with 3 clinical trials & 2010 being highest with 500 trial approvals. Mean ± SD Approval of 224.88 ± 172.46 with Median rate of 206 per year was observed. Trend of Trials approved by DCGI shows sharp peak around 2008-2010 which follows sharp fall around 2013. Conclusion: The present study highlights the impact of these new regulations on Clinical Trials registered for approval of DCGI.