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Drugs and Clinical Trial Rules, 2019
March 29 , 2019
1951 days
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- The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules with an aim to promote clinical research in the country.
- The new rules will ensure patient safety and the ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
- Drug Controller General of India (DCGI) has waived off the clinical trial for the drugs approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US.
- Clinical trial is a research study that determines whether a new drug is both safe and effective for humans.
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