Bad publicity has added to the woes of an industry worried by regulatory uncertainty

The Indian clinical trial industry is beset by uncertainty. Campaigners have petitioned the courts claiming that drug companies are exploiting poor people and this has led to more than 100 trials being put on hold. Moreover, earlier this year the government amended drug laws to tighten regulatory mechanisms, provoking the US National Institutes of Health to suspend trial enrolment in the country. Under the new regulatory regime, only five trials have been approved so far.

The Indian clinical trial industry’s market was expected to soar to $1 billion (£630 million) by 2016. But now experts doubt that industry will hit this milestone in the next three years. V Mohan, a diabetes specialist based in Chennai who has been involved in several trials related to diabetes-related drugs, says: ‘The recent negative attention is likely to affect clinical trials in the country. Unfortunately, this will be a big loss for India.’ Industry experts agree. Suneela Thatte, president of the Indian Society for Clinical Research, admits there has been a slowdown. ‘While we’d like to work towards a robust regulatory mechanism, it should not happen at the cost of the normal work of the industry,’ she says.  

Some researchers are already beginning to experience the effects of the fallout. Rupam Borgohain, a neurologist and professor at Nizam’s Institute of Medical Sciences, says: ‘The negative coverage in the media brings a bad name to research, and the work of academics involved with ethical clinical trials gets affected.’ Over the years, Borgohain has been involved with several clinical trials for drugs for diabetic neuropathy and Parkinson’s disease, and his trials have been sponsored by big-name firms such as GlaxoSmithKline. He says of the slowdown: ‘One of the reasons definitely is the economic downturn, but the media attention over the last couple of years has also played a major role, too.’

Borgohain is normally very busy with trials, but currently is not working on any. He laments that this is a great loss to science. ‘Working on global clinical trials brought us face-to-face with investigators from all over the world. These interactions provided a great learning experience for the indigenous researchers,’ he says. Additionally, fees paid by the sponsors in exchange for the work helped Borgohain buy equipment for the hospital.

Vinay Goyal, a neurologist at the All India Institute of Medical Sciences, who has supervised trials at the institute, is in a similar situation to Borgohain. He says the only way around this problem is to have a central authority that gives approvals for trials. ‘Right now there are several nodal points for the approval process, each with a different set of requirements,’ he says. ‘It makes the approval process cumbersome – it can take three months to one year for a trial to be approved.’

Thatte, however, is still optimistic. ‘Pharma companies need to test drugs in all representative populations where they will be used, so India will not be written off from their clinical research programme anytime soon,’ she says. ‘But right now they are in a wait and watch mode, and will make a call once there is more clarity on regulations.’