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<p class="abstract"><strong><span lang="EN-US">Background:</span></strong>To analyse the number of randomized clinical trials and subsequent new drug approvals in India and USA.</p><p class="abstract"><strong>Methods:</strong> Data was collected for completed randomized clinical trials done by multinational in India and USA from www.clinicaltrials.gov during the period from 1/1/2009 to 31/08/2014 and the subsequent new drug approvals from 1/1/2010 to 31/10/2015 for India obtained from Central Drugs Standard Control Organization (CDSCO) (www.cdsco.nic.in.) website and for USA obtained from United States Food and Drug Administration (USFDA) (www.fda.gov) website. Results were measured in terms of percentage of completed randomized clinical trials for investigational medicinal products (IMP) leading to new drugs approvals in India and USA.</p><p class="abstract"><strong>Results:</strong> A total of 163 randomized clinical trials fulfilled the eligibility criteria. Regrouping them for the same sponsor and IMP resulted in a total of 93 randomized clinical trials. In India, 13 drugs (13.93%) were approved by CDSCO, whereas in USA, 35 drugs (37.62%) were approved by USFDA out of a total of 93 randomized clinical trials. High number of randomized clinical trials were conducted for cancer (17.20%) while less number of randomized clinical trials were conducted for gastrointestinal conditions (3.22%).</p><p class="abstract"><strong>Conclusions:</strong> This study revealed that, there exists a wide gap between the new drug approvals permitted by USFDA and CDSCO. Thus there is disparity in the number of clinical trials conducted and market availability of new drugs in India showing that India is lagging behind the USA in approval of new drugs. The regulatory authorities, investigators and institutional review boards should ensure the availability of new drugs in India after they have been researched in the population<span lang="EN-US">.</span></p>

<p class="abstract"><strong>Background:</strong> Clinical trials are gold standard in the field of evidence based medicine. Registration of clinical trials facilitates the dissemination of information among clinicians, researchers and patients. Earlier, researchers were interested only in publishing positive results of their study. The negative results were never published resulting in bias in reporting the results of such clinical trials. It is now mandatory to register all clinical trials done in India at National Institute of Medical Statistics (NIMS) hosted at Clinical Trial Registry - India (CTRI) website to ensure transparency, accountability and accessibility of clinical trials. This study was planned to analyze the number of clinical trials registered under CTRI from 2007 to 2015. The information regarding the registration of clinical trials was accessed from the website www.ctri.nic.in.</p><p class="abstract"><strong>Methods:</strong> The information on registered clinical trials was obtained from the website www.ctri.nic.in. The clinical trials registered with CTRI from 2007 to 2015 were noted for analysis.</p><p class="abstract"><strong>Results:</strong> Maximum number of clinical trials registered in the year 2015 (1113), followed by year 2014 (1089), 2013 (990), 2012 (959) and 2011 (748) while least number of clinical trials registered in the year 2007 (32). Results revealed that there is wide gap the number of clinical trials registered in between year 2007 to 2015 and also revealed that number of clinical trials registered are increasing in order from year 2007 to year 2015.  </p><strong>Conclusions:</strong> The registrations of clinical trials improve the reliability of data generated, assist clinicians to interpret research, minimizes duplication of trials and prevents exposure of volunteers to potential risks.