Challenges and prospects for clinical trials in India: A regulatory perspective

At the behest of the Hon’ble Supreme Court of India,1 the regulatory landscape for clinical research in India witnessed an overhaul in early 2013, resulting in a flurry of mainstream media articles wrongly referring to  the aforementioned order as a ban on clinical research in India. While it is true that the number of ongoing and upcoming trials dipped from that point onwards, but this was more to do with the wait-and-watch policy of sponsors2 of clinical trials, citing the supposedly stricter requirements while conducting them that were put forth. The foremost was that of providing for examination of serious adverse events and procedures for compensation in case of clinical trial-related injury or death. The second was the audiovisual recording of the informed consent process. The third was the arbitrary cap on the number of trials an investigator could simultaneously undertake. The fourth was the requirement of a minimum threshold of public medical institutions (with predefined standards) to be chosen as clinical trial sites3 . The fifth was about inspection and monitoring of clinical trials, and finally about registration requirements for EC.