Impact of new regulations on clinical trials in India

Abstract

<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 & 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>

Clinical trials in low and middle-income countries — Successes and challenges

“…Many of these trials were unfortunately enabled by exploitation of ignorance, poverty, and poor awareness of the human subject rights and safety issues. For instance, in India, there was an initial surge in pharmaceutical clinical trials until 2010 and a sharp fall with decreasing trend subsequently (Chawan et al, 2015). Major concerns included poor quality of informed consent, poor quality of scientific and ethical review processes, sub-optimal regulatory processes for new drugs and clinical trials, inadequate protection of the patient's rights and compensation for trial-related injury and, more importantly, lack of post-trial population access to prohibitively expensive cancer drugs which were proven effective in LMIC settings (Shapiro and Meslin, 2001).…”

Recent Advancement in Regulatory Guidelines for Clinical Trials in Usa and India

“…However, it is still in the draft stage due to change in the expert panel of CDSCO. [21] The recent amendments in schedule Y are  GSR 889E; 12 th Dec. 2014: Notification about specific provisions in respect of compensation for ineffectiveness and placebo-controlled trials [22]  GSR 11E; 6 th January 2016 is in draft stage for amendments in schedule Y…”

Sponsorship and characteristics of medical device clinical trials registered in Indian Trial Registry

“…Also, foreign sponsors who are conducting clinical trials in India are from industry (MNCs). This may be because carrying out trials in India provides a lot of advantages to sponsors such as access to huge and diverse population, high global disease burden, reduced cost (almost half compared to developed countries), more skilled investigators, less regulatory barriers compared to the US FDA and so on [32,33,34]. All these advantages are the potential factors which benefited pharmaceutical or medical device companies [1,35,36] and are driving sponsors to shift their clinical trial activity to India and India has emerged as the "clinical trial hub".…”