Analysis of randomized clinical trials leading to new drug approvals in India and USA

Abstract

<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>

Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020

“…The unethical behaviour of few pharmaceutical agencies with regards to medical trials was also detected [ 5 ]. Since India has a sizeable native population, Indian pharmaceutical industries focus on new drug discovery and development for cost-effective trials, which would help to increase the number of clinical trials in India [ 6 , 7 ]. However, it is reported that some trials were conducted in an unethical manner without any regulations and do not hold any ethical approval [ 8 , 9 ].…”

An analysis of clinical trials registered with CTRI in India from 2007 to 2015

“…6 Due to the of presence large treatment-native population and cost-effective trials, the Indian pharmaceutical industries focused on new drug discovery and development which resulted in an increase in the number of clinical trials done in India. 7,8 But such trials were conducted without regulations and necessary ethics approval. To ensure transparency, accountability and accessibility of clinical trials, it is mandatory to register clinical trials in India at Clinical Trial Registry -India (CTRI) website www.ctri.nic.in, hosted by National Institute of Medical Statistics (NIMS).…”