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India Speed-Up For Phase I Trial Approvals Draws Criticism

This article was originally published in PharmAsia News

Executive Summary

India's effort to step up its approval process for Phase I trials has drawn warnings from critics that the lack of expertise could be a problem. Currently, India allows only drug makers who have developed their drugs in the country to conduct early-stage trials. The government is trying to reduce its approval time for those trials, drawing criticism from some experts. The Indian drug industry is pressuring the government to reduce its approval time to 30 days, similar to the practice in Western countries. (Click here for more

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