Lawsuits mount as India pushes trial reforms

For years, India's poor have been recruited into clinical trials with the promise of life-saving treatment, often without proper consent or education on side effects. Now, as the country works to tighten its regulations, more and more families are suing for retribution, The Economic Times reports.

Among scores of legal petitions is that of the Pathaks from Madhya Pradesh, the newspaper reports. They claim their 72-year-old uncle was administered Eisai's Atopaxar for a heart problem, unaware that the drug was designed to treat anxiety. The trial left him with severe dementia, the family told The Economic Times, and he never would have entered the study had he known it wasn't cleared for his illness.

The spike in litigation comes as India's Supreme Court moves to crack down on the country's lax regulations for clinical trials. After cases of unethical trials and unpaid compensations reached the court early this year, justices demanded the Central Drugs Standard Control Organization come up with a plan to make the country's clinical outsourcing industry safer.

Under current law, any physician can conduct a trial with almost no oversight, and 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.

The country is in the process of implementing stricter regulations, requiring studies to be held in a GMP-compliant facility, approved by an ethics committee, registered with regulators and subject to random inspection.

In the run-up to reform, many in India's clinical research industry worried that tougher laws would sap up demand for trials in the country, and, at least in the short term, they appear to be correct. As of April, CDSCO had approved only 12 clinical trials, far below last year's 262 and 2010's peak of 500, and the Drug Controller General said the sluggish rate was only partially due to regulators taking a closer look at applications.

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