One of the increasingly contentious public health issues in India is the manner in which clinical trials are conducted for new drugs and the manner in which these new drugs are subsequently approved for use on Indian patients.
The HPV clinical trials on tribal women without their “informed consent” was a major scandal that is currently the subject of litigation before the Supreme Court. Similarly, the process by which the Drug Controller General of India (DCGI) approves new drugs for Indian patients has been the subject of much controversy. For several years now, Indian doctors have been pointing out how the DCGI has been playing loose with the law to grant approval for drugs that lack substantive clinical data and that have not been approved anywhere else in the world.
