Medical companies have complained before that a cumbersome bureaucracy and lack of legal clarity makes getting clinical trials approved in India a slow and difficult process. A high profile case brought to the Supreme Court has made the process even slower.
Two groups of activists filed cases last year stating that drug companies and CROs have been illegally conducting trials on poor people without their knowledge or consent. The cases have gained much notoriety and are being heard in India’s Supreme Court. The activist groups have asked the Court to suspend all trials for new chemical entities.
The clinical trial process in India was already slow. Now these cases have made the process even slower. The approval time for initiating drug trials in India is typically 6-8 months. Contrast that with the 28 days it takes in Europe and Canada. The trial has made government officials nervous and reluctant to approve new clinical trials. Companies seeking new clinical trials in India will face more questions and a longer process. As a result, some global drug companies are turning elsewhere for their clinical trials.