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New Drugs and Clinical Trial Rules (2023)
July 6 , 2023
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- An amendment to the New Drugs and Clinical Trial Rules (2023), was recently passed by the Government of India.
- It aims to replace the use of animals in research, especially in drug testing.
- The amendment authorises researchers to instead use non-animal and human-relevant methods.
- It includes technologies like 3D organoids, organs-on-chip, and advanced computational methods to test the safety and efficacy of new drugs.
- The millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.
- The “organ-on-a-chip” are AA-battery-sized chips lined with human cells connected to microchannels, to mimic blood flow inside the body.
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