Event Description Impact Notes
Deaths in HPV vaccine study 4 teenage girls die during vaccine trial [41] Foreign sponsors (Gates Foundation, PATH) blamed for using Indians as “guinea pigs” [41] A government-commissioned committee confirmed the deaths were not related to the vaccine [41]
CDSCO report Government report finds deficiency in enforcement of regulation [40] Activist protests, Supreme Court intervention, regulatory overhaul, hold on clinical trial approvals [18,19,30] “Collusion” of regulators with industry sponsors is decried in the media; it is inferred by the identification of copycat letters sent by physician experts to the regulators in support of pharmaceutical clinical trial applications
NGO petitions Requesting inquiry into the small number of trial adverse events and deaths resulting in compensation [33] Leading to Supreme Court January 2013 decision (see below)  
Supreme Court decision Petitioned by activists to investigate compensation for trial-related adverse events and deaths Regulatory overhaul; 3-month hold on clinical trial application approval [19,25]  
NIH trials in India “on hold” June 2013 announcement amid perceived regulatory and legal uncertainties [42] Reduction in the amount of clinical research [19,43]  
FDA inspections FDA issues warning letters to Ranbaxy, Wockhardt, and Jubilant Diminished confidence in Indian pharmaceutical industry Quotes from FDA inspectors:
•“submitted untrue statements of material fact” [44]
•“concerns about integrity of all data” [45]
•“innocent ignorance, surprising sloppiness, malicious malfeasance” (HRPP conference, 2013)
Quintiles closing early-phase unit Collaboration with Apollo Hospitals, Hyderabad–opened in 2010 One of only 2 early-phase units with international collaboration Closed due to “challenging external business environment”[46]
Compensation schemes Key feature of activist and judicial demands: compensation for adverse events and lack of therapeutic effect; ethics committees responsible for determining liability in clinical trials Initial compensation proposals prompt sponsor and investigator reluctance to conduct trials [18] Unresolved issues: determination of adverse-event causality; expectation of efficacy in clinical research; liability of placebo assignment; ethics committee resources and expertise to determine liability in clinical trials [38,30,47]
FDA, U.S. Food and Drug Administration; HPV, human papillomavirus; HRPP, human research protection program; NGO, non-governmental organization; NIH, U.S.
National Institutes
Table 2: Events Related to Standards of Clinical Research in India.
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