In a significant move towards drug development, the government of India recently passed an amendment to the New Drugs and Clinical Trial Rules (2023). This aims to streamline the process of drug development without the use of animals for the drug testing process.
The amendment emphasizes the importance of reducing, refining and replacing animal testing with alternative methods. It encourages researchers to explore alternative approaches, such as in silico (computer simulation) models and in vitro (test tube) studies, to minimize animal involvement.
Moreover, the amendment places a strong emphasis on the ethical treatment of animals during trials. It mandates that researchers provide a detailed justification for using animals, outlining the potential benefits of the research and the steps taken to minimize animal suffering. The rules also require researchers to adhere to internationally accepted guidelines on animal welfare.
This measure is expected to contribute to the advancement of scientific understanding and the development of safer and more effective drugs.
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