“We are losing out,” says Tata Memorial Hospital’s Dr Mohan Das Mallath, concerned about the uncertainty over research in the country.
“It reminds me of my days as a medical student (in the early 1980s), when the drugs we used were entirely developed outside the country,” he says, referring to the present slowdown in drug trials conducted in the country.
Losing ground
Drug companies are required to test their medicines on humans for safety and efficacy before they launch in the marketplace. And the number of such trials has dipped from over 500 in 2010 to 270 in 2011, say clinical researchers.
Clinical trials have not met the heady projections of $1.5 billion by 2010, and the size of the local drug trial segment stands at $400 million. As India loses out, countries such as South Korea, Malaysia and China are gaining ground.
The fear of clinical trials going awry, locals being used as “guinea pigs”, long approval timelines, and uncertainty in the regulatory environment are slowing the process, say researchers and industry-watchers.
Local doctors had begun to participate in global medicine trials. But uncertainty is threatening to set the clock back, says Dr Mallath, Director at Tata Memorial’s Centre for Cancer Epidemiology.
International sponsors of trials are hesitant, fearing that the rules may change midway through a trial; small biotech companies cannot withstand such costs, he adds.
Despite its advantages, India has fallen behind, says Mr Bart Janssens, Partner in consultant company BCG. China has overtaken India in terms of share of new trials — it rose from a 1:1 China-to-India ratio in 2008 to a 2:1 ratio in 2011, he says.
Ethical issues
A clinical research ecosystem is important for innovation and to make new drugs accessible to Indian patients, he says. On issues being raised about patients being involved in trials without their consent, he observes: the question is whether there is a systemic problem or if the stakeholders have behaved in a manner they should not have.
Better enforcement of the law will bring back confidence, observes Dr Arun Bhatt, President of ClinInvent Research. Korea, for instance, is accrediting doctors who undertake trials, leaving no scope for ambiguity, he points out.