Government notifies new rules for drugs and clinical trials
Health Ministry has notified New Drugs and Clinical Trials Rules, 2019 to promote clinical research by reducing the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country. New rules will ensure patient safety, as they would be enlisted for trials with informed consent. The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
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