Clinical Trials in India Still at Peril Due to Regulatory Burdens 
[Posted on: Thursday, August 11, 2016]

This week, the Indian regulators announced reversal of a rule from 2 years ago that restricted an investigator from participating in more than 3 clinical trials at a given time. This is a very minor change that has little practical impact on the status of clinical trials in India. The clinical trial industry in India has been in a dismal state for the last 5 years. There are only 35 Phase I clinical trials in India registered on clinicaltrials.gov, of which only 2 are not sponsored by the Indian government agencies or non-profits. There are 143 Phase 2 or Phase 3 clinical trials ongoing in India per clinicaltrials.gov, with only 61 or about 40% of those being industry-sponsored interventional clinical trials. In context of the size of Indian population and the potential need for new drugs, these numbers are abysmal. Since the hay days of 2007-2008 when there were more than 1000 clinical trials in India, the country has struggled due to over-regulation based on short-term social perspectives and political pressures. The condition of the clinical trial enterprise in India situation highlights several lessons for all emerging markets that look to promote their locations for clinical trials. The Indian clinical trial industry was on a promising trajectory in 2006-2008. Indian regulators had made major changes to the clinical trial rules in 2005 that made initiating sites in India very easy provided the trial was already approved by regulators such as the US FDA and EMA. India was promoted to be an ideal location for multinational clinical trials by virtue of its excellent English-speaking work-force, and large treatment-naïve patient population, along with business-friendly open market. The Indian clinical trial industry grew at an unprecedented rate between 2006-2009 with an explosion of new trials, several new CROs, and multiple new investigators. Experts predicted Indian clinical trial industry will keep growing and account for significant percent of global clinical trials.  However, the regulatory body in India, CDSCO, did not have the resources or training to adequately regulate its clinical trial industry. In 2010, there were a few complaints of unethical practices by certain investigators and CROs which caused a political firestorm leading to the CDSCO announcing a moratorium on all clinical trial approvals and a hold on all ongoing clinical trials. Since then the Indian regulators have released one after another disastrous plans. New committees were created to advise the regulators, laws were passed to compensate participants who got hurt while participating in clinical trials, whether or not it was drug related, informed consent was made onerous with additional requirements to make audio and video recordings of the informed consent process, requirements for certification of IRBs was made mandatory, and removal of the time-line for review of clinical trial applications made planning a trial almost impossible. There are only 6 clinical trial applications under review by the regulators currently. The clinical trial guidelines for India are bare bones and highly disorganized. The clinical trial infrastructure meanwhile collapsed for lack for business, sponsors withdrew ongoing studies and decided to exclude India from all global clinical trials, and the regulators exhibited neither the desire nor need for supporting a critical industry in the country. These series of bad decisions have crippled the clinical trial industry in India with few hopes of reversal in the near future. It needs more than allowing its investigators to take on more than three trials for the clinical trials to be relevant again in India.