The Indian Supreme Court yesterday ordered the central government to issue regulations mandating videotaped informed consent of all participants in any clinical trial conducted on Indian soil, as well as additional cost-benefit analyses of potential drugs before trials can proceed.
The precedent-setting directive comes as the two-judge panel continues to hear arguments on a petition filed in January 2012 alleging that multinational drug companies and Indian collaborators are using underprivileged Indians as guinea pigs in clinical trials. In July, the court ordered a temporary halt to 162 clinical trials then under way in India. Yesterday, it permitted five trials to resume and referred the other 157 to a new government advisory committee for more detailed scrutiny. The court asked the committee to compare the likely benefits of the trial drugs to treatments already on the Indian market while keeping in mind the nation’s medical needs, according to a report in The Times of India.
Observers say the court’s directives will impose a heavy burden on clinical researchers. “The intent is correct, but the path chosen by the court is tough,” says Maharaj Kishan Bhan, a vaccine researcher and former secretary of the Department of Biotechnology. While videotaping informed consent would provide additional accountability, Bhan says, “the right balance has to be struck between how much more additional burden needs to be loaded on researchers vis-à-vis requirements of ensuring better patient safety.”