In 2012, 436 people died during clinical trials in India, a number nearly unchanged from the previous year despite an increase in governmental scrutiny.
The Health Ministry is yet to determine how many of the deaths can be attributed to drugs alone, but the finally tally is nearly identical to 2011's 438 clinical trial deaths, which fell from 2010's 668, according to DNA India. In 2011, 16 deaths were directly caused by trials, preceded by 22 in 2010.
In the case of study-related death, the ministry requires study conductors to pay for medical care and disburse compensation to the patient's family. The amount of that compensation, though, is decided by the company holding the trial, something India's Central Drugs Standard Control Organization has proposed to change.
Under pending reforms put forth this month, sponsors and CROs would be required to pay out an amount determined by the Drug Controller General of India within 30 days of injury or death in a clinical trial, and if they don't, CDSCO can cancel a trial and ban a company from conducting studies in the country.
The rest of CDSCO's proposed changes are designed to bring India's clinical trial regulations up to speed with most of the world.
Under Indian law, there are no minimum clinical standards for trials, so any physician can conduct a legal trial at any private clinic. If approved, CDSCO's rules would make it so that every trial must be held in a GMP compliant facility, approved by an ethics committee, registered with regulators and run transparently. Serious adverse events would have to be reported within 10 days, and all trial sites would be subject to random inspections.
- read the the DNA India story