The clamor over India's loose clinical trial regulations has spurred the country's regulators to propose stricter standards, but some scientists say tighter rules could hamstring research and the slow down the nation's CRO industry.
While the number of trial-related deaths in India has declined of late--from 668 in 2010 to 438 in 2011--regulators have proposed instituting unannounced inspections of trial facilities and stricter guidelines for the ethics committees that approve studies, Nature reports, aiming to make trials safer and more transparent.
Furthermore, India's Central Drugs Standard Control Organization (CDSCO) wants to standardize the compensation patients or their families receive in the event of trial-related injury or death. As it stands, researchers decide how much to pay out, and, in 2010, most injured patients or grieving families received between Rs 1.5 lakh and Rs 2.5 lakh (about $2,700 and $4,500) in one-time settlements, The Times of India reported. Under the CDSCO's new proposal, the regulator would calculate a settlement amount by accounting for a patient's age, income and resultant disability.
But some scientists say that plan casts too wide a net, asking researchers to pay patients who experience adverse events while taking placebos or through drug pairings unbeknownst to the trial stewards, according to Nature. Increasing the number of payouts would also drive up insurance charges, they argue, and the costs of running trials in India could snowball and imperil the country's CRO industry, pricing out small and mid-size drugmakers and leaving only large pharmas in the marketplace.
Others say the proposed reforms don't go far enough. Falguni Sen, director of the Global Healthcare Innovation Management Center at Fordham University, said Indian CROs face a crisis of public confidence. Past scandals--like the one publicized by NBC's "Dateline" this year--have cast a shadow over the country's clinical research industry, Sen told Nature. He suggests that the country adopt strict standards and set up special courts to adjudicate cases of medical misconduct.
The Indian government is still taking public comment on the proposed reforms, and it is unknown when the legislature will vote on the issue, according to Nature.
- read the Nature report