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New Regs

India's health ministry has developed draft rules regarding compensation for deaths and injuries related to drug trials, reports The Hindu. The guidelines include a mathematical formula to calculate such compensation, taking four factors into account: age, income, the seriousness and severity of the disease, and percent permanent disability. In addition, The Hindu notes that the guidelines also place victims into different categories based on whether they were healthy or ill when they joined the trial. "The most major flaw is that the guidelines have left children and non-earning members of the family outside the ambit of compensation. Secondly, the income parameter is problematic as most of the drug-trial victims are poor," Anand Rai, founder of the Clinical Trial Victims Association of Madhya Pradesh tells The Hindu. There is a 30-day comment period on the draft guidelines.

HT: Ed Silverman at Pharmalot

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