India's Central Drugs Standard Control Organization has released its proposed clinical trial reforms, and while most fall in line with industry expectations, ACRO says the suggested rules on patient compensation are vague and problematic.
Under the proposal, trial runners are required to pay patients if the treatment does not reach its "intended therapeutic effect," and ACRO spokesman John Lewis told Outsourcing-Pharma that the provision misunderstands the entire purpose of conducting clinical studies.
And the demand comes with teeth: If a sponsor or CRO doesn't pay out an amount determined by the Drug Controller General of India within 30 days, CDSCO can cancel a trial and ban a company from conducting studies in the country. With such high stakes, the country owes the industry a closer look at whether its compensation proposal is reasonable, Lewis said.
The rest of the regulations come as no surprise. CDSCO wants to make it so that every trial must be held in a GMP facility, approved by an ethics committee, registered with regulators and transparent. Serious adverse events would have to be reported within 10 days, and all trial sites would be subject to random inspections from CDSCO.
CDSCO's proposal responds to a demand from the Supreme Court to come up with a way to clean up India's clinical trial problems, and, if implemented, the 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.
Beyond the humanitarian concerns, many in India's government worry that, unless they clean up their regulatory act, major drugmakers and CROs will ditch the country in favor of on-the-rise trial sites like South Korea and Taiwan, which offer similar arbitrage opportunities without the boatload of bad press generated by India's industry.
- read the Outsourcing-Pharma story
- check out CDSCO's proposal (pdf)
Special Report: Top Emerging CRO Markets