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India Aims To Improve Review, Regulation Of Clinical Research, Compensation

“Following criticism over a spate of patient deaths from adverse events during clinical trials, India has begun tightening up rules for clinical research and compensation as well as expanding its pool of medical experts,” SciDev.Net reports. A health ministry official said the ministry would submit to Parliament amendments to existing laws with the aim of strengthening the approval process for clinical trials, according to the news service. In addition, the Central Drugs Standard Control Organisation (CDSCO) is expanding its pool of experts, “has asked ethics committees for tougher inspection regimes,” and in August “issued guidelines on compensation to be paid in case of clinical trials-related death or injury,” the news service notes. According to SciDev.Net, “These steps follow the report of a parliamentary committee, in May 2012, which found that a large number of imported drugs had been cleared without trials,” “includ[ing] drugs that had failed to be cleared for use in the parent countries” (Sreelata, 9/12).

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