Accelerated Reliance on Digital Animal Replacement Tech

While Europe is talking about non-animal replacement tests to be used for drug development and research purposes, US FDA is acting upon it with a detailed roadmap aimed at rapidly reducing animal testing in preclinical safety assessments. These developments clearly provide huge opportunities for global companies that are developing alternative methods such as organoids, 3D bioprinting, digital animal replacement technology, computer simulation, to name a few. But where does India stand in this regard, and how skilled are we to make this shift?

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On April 29, the National Institutes of Health (NIH) in the US announced the adoption of a new initiative to expand innovative, human-based science while reducing animal use in research. In particular, the NIH intends to establish the Office of Research Innovation, Validation, and Application (ORIVA) to develop, validate, and scale the use of non-animal approaches across the agency’s biomedical research portfolio and serve as a hub for interagency coordination and regulatory translation for public health protection.

Developing and using cutting-edge non-animal research models very well aligns with the US Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals.

Simultaneously, the European Medicines Agency (EMA) has released a revised draft paper that outlines non-animal replacement tests manufacturers can use to eliminate the use of animals in pharmaceutical testing. Further, the European Commission has confirmed plans to finalise its ‘Save Cruelty Free Cosmetics’ roadmap by early 2026, setting the stage for a gradual transition toward non-animal testing in chemical safety assessments.

Where does India stand in this scenario? Although an amendment to the New Drugs and Clinical Trial Rules (2023), passed by the Government of India in 2023, aimed to replace the use of animals in research, especially in drug testing, not much progress has been made so far. Indian regulatory bodies are still working out ways to strengthen the use of non-animal testing methods in laboratories across the country, as they are aware that completely eliminating animal models may not be a feasible process.