India's government is struggling to crack down on loosely regulated clinical trials that have killed hundreds of patients around the country, and while it's unclear if its efforts have made the process safer, they've certainly slowed things down.
As The Hindu reports, India's Central Drugs Standard Control Organization (CDSCO) has approved only 12 clinical trials in 2013, paltry compared to last year's 262 and 2010's peak of 500. The CDSCO is paying close attention to the applications put before it after the Supreme Court chided regulators for failing to rein in trials "causing havoc to human life" in the country.
But at least part of the sluggish start to the year is due to a drastic drop in applications, Drug Controller General G.N. Singh told The Hindu, as sponsors and CROs may be looking elsewhere to conduct trials thanks to India's renewed focus on regulation. But a slip in India's share of the global clinical trials industry hardly outweighs the government's duty to protect its citizens, Singh said.
"The safety and well-being of Indian subjects participating in clinical trials is the foremost in our minds," he told the newspaper. "This is why the government has tightened the norms putting the onus of safety of participants on firms conducting the trials. It is for the first time that such norms have been put in place."
The decline in demand for Indian trials is just what opponents of regulatory reform feared when the debate began, warning that slower approval times for clinical trials would make outsourcing to the country more costly, leading sponsors and CROs to take their business to other countries.
Under India's tighter trial laws, studies must be held in a GMP-compliant facility, approved by an ethics committee, registered with regulators and subject to random inspection.
- read The Hindu story