Data from: A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa

Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Design Construction and analysis of comprehensive database of completed randomized controlled clinical trials based on clinicaltrials.gov from 1st January 2005 to 31st December 2010 and drug approval data from 2006 until 2013 for India and South. Africa. Setting: USA, EU, India and S. Africa. Main outcome measures: Percentage of completed randomized clinical trials for Investigational Medicinal Product (IMP) leading to new drug approval in India and S. Africa. Results: A total of 622 eligible randomized controlled trials were identified as per search criteria for India and S. Africa. Clustering them for same sponsor and same Investigational New Drug (IND) resulted in 453 eligible trials i.e. 224 for India and 229 for S. Africa. The distribution of the market application approvals between EU / U.S. as well as India and South Africa revealed that out of clinical trials with the participation of test centers in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorization in EU / U.S outside of these countries without an New Drug Application (NDA) approval in India or South Africa. Conclusion: Despite increase in the clinical trial activities there is a clear gap between number of trials done and market availability of these new drugs in India and S. Africa. International as well as local regulatory authorities, investigators, Institutional Review Boards (IRB’s) and patient group should direct their efforts to ensure availability of new drugs in market which were tested and researched on their population.