| 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] |
