As I have blogged about extensively on this site here, here, and here, amongst dozens of other articles and interviews I have done on this topic, clinical trial regulations in India have tightened to the point where Pharmaceutical Sponsors and CRO’s are conducting their trials elsewhere, mostly China and other Asian countries, although regulations are starting to tighten up there as well.
According to a story in one of India’s largest publications earlier this month, from January to April of 2013, only 12 trials were granted approval (meaning ability to actually begin conducting the trials) by the DCGI (think Indian FDA) as opposed to hundreds of trials being approved under the same timeframe in years past. I believe it’s safe to say that the Indian clinical trial “gold rush” is officially over, and while the clinical research industry will eventually stabilize in that country, it’s bragging rights as clinical trial outsourcing capital of the world exist no longer.
Some of the new regulations implemented by the Indian Supreme Court are to establish minimum compensation levels for any trial participant that experiences a serious adverse event or death, and establishing independent ethics committees such as those which exist in the United States and Europe that are comprised of members not associated with the outcomes of the trials. While this does not seem like too much to ask, most Pharma and CRO companies have already moved on to other outsourcing countries such as China for conducting their trials cheaper and quicker. One can only hope that they learn there lessons from the Indian experiences.
