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A streamlining effort
May 2019
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NEW DELHI—A new ruling from the Indian government states that drugs that are approved for use in certain developed markets will be automatically allowed in India so long as the trials included Indian participants, according to an article by Teena Thacker of Mint. In addition, under the Drugs and Clinical Trials Rules, 2019, local clinical trials can be waived for drugs approved and marketed in the following areas: the European Union, the U.K., the U.S., Australia, Canada and Japan. Mint also noted that the Indian government has eliminated a clause that states that the trial sponsor must pay 60 percent of compensation up front should a patient experience permanent disability or die. The new rules state that a sponsor will pay the total amount should it be established that the injury was the result of the clinical trial.

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