The Indian Supreme Court has ordered the central government to ensure that the informed consent of any patients in clinical trial be videotaped.

The clinical trial industry in India is worth at least US$500 million a year – and it is growing. Drug companies are drawn there because R&D costs are up to 60% lower. But too often the trials have exploited the poor education and poverty of the subjects. An editorial in the Indian Express lashes the companies for behaving  “in deceptive, even immoral, ways without informed consent, and with misrepresented data”.

Now the Indian Supreme Court has ordered the central government to ensure that the informed consent of any patients in clinical trial be videotaped. It also wants the government to compare the likely benefits of the trial drugs to drugs already on the Indian market while keeping in mind the nation’s medical needs, according to a report in The Times of India.

Maharaj Kishan Bhan, a former secretary of the Department of Biotechnology, was not enthusiastic about the move for better protection for the patients. “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,” he said. 

Michael Cook
Creative commons
clinical trials
human research ethics
India