As many as 2,868 people have died in Indian clinical trials over the past 7 years, and sponsors and CROs have paid out compensation in just 45 of those instances, according to India's Business Standard.
Of those deaths, 89 were found to result directly from the trials, the paper reports, and the lack of regulations has made it impossible for the government to demand accountability from clinical researchers.
Under current law, sponsors are required to pay compensation for deaths that result from studies alone, but amounts are decided by study sponsors, and the law doesn't mandate a timeframe for payout. As a result, companies tend to drag their feet if they pay at all--as Business Standard notes, of the 436 trial deaths in 2012, 16 were determined to be trial-caused, and only two have been compensated.
That rule is among the many India's Central Drugs Standard Control Organization is hoping to change. In CDSCO's pending trial reforms, 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.
CDSCO also wants to mandate that every trial be held in a GMP-compliant facility, approved by an ethics committee, registered with regulators and transparent. Under its recommendations, serious adverse events would have to be reported within 10 days, and all trial sites would be subject to random inspections.
The proposed reforms are a response to demands from India's Supreme Court, which was outraged by the lack of oversight in the country's clinical research industry. If implemented, the new rules would go a long way toward clamping down on unethical studies: Under current law, there are no minimum clinical standards for trials, meaning any doctor can conduct a legal trial at any private clinic in the country with almost no oversight.
But support for stricter rules isn't unanimous. Some in India's CRO industry say strengthening regulations will just increase the cost of doing business in the country, eventually pricing out local drugmakers and making India affordable only for multinational corporations.
- read the Business Standard story