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<p class="abstract"><strong><span lang="EN-US">Background: </span></strong>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.</p><p class="abstract"><strong>Methods:</strong> 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.</p><p class="abstract"><strong>Results:</strong> Total 1799 Trials Approved. 2007 had lowest approvals with 3 clinical trials &amp; 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.</p><p class="abstract"><strong>Conclusion:</strong> The present study highlights the impact of these new regulations on Clinical Trials registered for approval of DCGI.</p>

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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>