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India’s Clinical Trial Overhaul

Amid allegations of malpractice and poor oversight, the country’s healthcare industry is determined to make clinical trials safer and more effective.

Cristina Luiggi

It is estimated that more than 600 patients died during clinical trials in India in 2010. Currently, the country has no system in place to compensate those injured or killed during trials and there is little oversight to ensure that those who enroll have given their informed consent and have been properly lectured on the treatment risks, Nature reported. As a result, the country’s health officials have called for urgent reforms to the clinical trial process.

“People were saying they were being used as guinea pigs,” Nandini Kumar, former deputy director-general of the Indian Council of Medical Research, told Nature.

Among the proposed reforms is the establishment of a compensation system for the families of patients that died and those who have been harmed, tougher rules for committees that approve trials, special courts to hear malpractice claims, and a staff and resource boost to India’s drug regulation agency—the...

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