Through May 2014, 76 trials have been approved, which is more than triple the number of trials approved through May 2013, when only 24 trials approved.
The year is on pace to top 2013 as a whole, when a total of 107 trials were approved, but it is unlikely to get back to the pace of 2012, when 262 trials were approved.
The mix of CROs conducting trials on the subcontinent also seems to be shifting between 2012 and today. In 2012, Quintiles led the way with 10 different trial approvals, while data from 2013 and 2014 list only one trial approval for the world’s largest CRO.
PPD, which followed Quintiles in 2012 with five trial approvals, is also only listed as conducting one trial in 2014 – a Phase III study for AstraZeneca for ceftazidime/avibactam to treat urinary tract infections. Similarly, Parexel is only listed as conducting one trial in 2013 and 2014 – a Phase IIIb/IV study of exenatide as a treatment for Type II diabetes.
Other, more local Indian CROs seem to have picked up the slack for the multi-national CROs, with Max Neeman, which had six trials approved in 2012, and MSN Laboratories seeing a couple of trial approvals each.
Other CROs are also now looking at India as a potential growth driver. CRO Theorem recently partnered with Excel Life Sciences to conduct more trials on the subcontinent.
Theorem SVP Marc Hoffman told us: “Theorem has carefully and cautiously monitored the state of clinical research in India and the changes over the last two years in DCGI Regulations and Guidance…Theorem has always sought to bring best-in-class solution to every challenge and this is no different... India represents a huge and under-served market and we are well-positioned to take advantage of this.”
Regulations
The revelation of an uptick in trial approvals this year comes just a week after India’s CDSCO (Central Drugs Standards Control Organization) issued a raft of new regulations. Among those, CDSCO is saying investigators can only work on a maximum of three trials simultaneously, and that trials must be properly designed with placebo controls.
The regulator also recently laid out a new compensation formula for patients killed or injured in a trial.
But the most recent Union Budget attempts to remove an exemption on a 12.3% service task that previously kept the cost of trials down. Indian Parliament has yet to decide on whether it will keep that exemption.