With most drug candidates failing in humans, India’s draft rules bet on the wrong science in animal lab testing

The past decade has seen a shift in drug, vaccine and chemical testing, with regulations and research favouring emerging technologies based on human biology over animal testing.

But Committee for Control and Supervision of Experiments on Animals' (CCSEA) draft Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules 2026, risks dialling back progress that has been achieved towards advancing human-relevant, non-animal approaches in India.

Also read: India leads on non-animal testing and its draft lab animal rules threaten to undo that


The move towards human-based testing is driven by the fact that only 1-2 out of 10 drug candidates discovered in the lab succeed in human clinical trials. One reason for this 'valley of death' between basic research and clinical translation is the inability of animal-based preclinical tests to reliably predict human responses.

This has spurred countries and regulators to develop modern, human-relevant models. These systems include organoids, which are few-mm-sized complex cellular structures that mimic certain aspects of human organs; organs-on-chip, microfluidic chips lined with human cells; reprogrammed stem cells; 3D-printed organs; and advanced computational models. Their adoption is being incentivised through policies and funding.

Last year, the US National Institutes of Health (NIH) announced new initiatives to prioritise human-based technologies. In terms of funding, the US has launched a $400 mn funding programme to advance new approach methodologies (NAMs). China has launched its own programme to do the same. In India, MoHFW released New Drugs and Clinical Trials (Amendment) Rules 2023, which allow the use of human biology-based test methods to test the safety and efficacy of new drugs.

Both Indian Pharmacopoeia Commission and BIS have set up working groups for human-based non-animal methods to incorporate these methods into national standards. ICMR and Biotechnology Industry Research Assistance Council (Birac) have funded several NAMs projects across labs and startups.

But the draft rules risk reversing the progress India has made. While the rules state that 'replacement and reduction' are a core purpose, a clear mandate that NAMs should be considered first, and that justification needs to be provided when they are not used, is missing.

While its predecessor, Breeding of and Experiments on Animals (Control and Supervision) Rules 1998, stated that NAMs shall be used 'wherever possible', it also did not define NAMs, say, who decides what is 'possible', or require any proof. The draft also does not require national reporting of how many animals are used, by species, purpose or severity. What isn't measured or reviewed may not be replaced.

The new draft rules, instead, increase the scope of animal use by allowing the use of animals protected under Wildlife Protection Act, as well as wild, stray and feral animals of domestic species, if justified. But the use of protected species and wild animals in experimentation cannot be viewed from the point of scientific justification alone, as it can have a widespread impact on ecology and the environment.

Studies have shown that experiments can yield different, even contradictory, results when conducted in the lab and in field settings due to genetic and physiological differences. Unknown genetic and medical backgrounds of wild and stray species further add to scientific variability, and one may require a much larger number of individual animals to counter this disadvantage. Also, sourcing animals from the wild for human contact or use adds to zoonotic risk.

The draft rules expand the definition of an 'establishment' to include places 'not wholly enclosed or covered' and mobile facilities. While emerging technologies demand specialised laboratory infrastructure and stringent controls, this broader definition risks diluting standards for animal experimentation, increasing biosecurity risks and undermining efforts to build scientifically rigorous research infrastructure.

While much of the draft closely follows the EU directive on severity classification and animal use, it omits key provisions that promote alternatives: state support for developing and validating them, a reference laboratory for validation, and a bar on animal procedures where a recognised non-animal method exists.

India has considerable strengths in pharma, biotech, IT, AI, and engineering and scientific talent, backed by progressive government policies. The draft rules can accelerate change by restoring the 'NAM-first' justification clause, requiring documented searches for alternatives in research protocols, publishing annual statistics on animal use and setting up a national NAM validation centre.

India cannot lead the post-animal era of biomedicine with rules written for the last one. The draft rules should put 3Rs - replacement, reduction, refinement - at their heart. While they invoke the 3Rs, they give insufficient weight to replacement: substituting animal experiments with scientifically valid alternatives. Restore it as a priority, or India risks surrendering a frontier it is well placed to lead.

(Mishra is director, Tata Institute for Genetics and Society (TIGS), Bengaluru. Parvatam is senior programme director, research and toxicology, Humane World for Animals India)