Call to reduce laboratory animal use is not driven by ethics alone

The Draft Laboratory Animals Rules, 2026 is out of step with the technology India has already adopted and with the department that adopted it

By Shambhavi Naik and Aditi Palo

On October 6, the Ministry of Fisheries, Animal Husbandry and Dairying proposed the Draft Laboratory Animals Rules, 2026 under the Prevention of Cruelty to Animals Act, 1960, to update standards for scientific and educational experiments involving animals. This is a timely step as the older frameworks predate advances in biomedical research that now offer better models than animal-based ones. The rules recognise the need to apply the principles of replacement, reduction and refinement to using animals in experimentation and teaching. However, while the intent is correct, the actual provisions are not aligned with the 3R principles.

This misalignment points to a deeper fragmentation of the use of animal models across government departments. There are further questions about animal welfare that have been raised separately by others, but herein we make an argument that the draft is out of step with the technology India has already adopted and with the department that adopted it.

Three provisions of the draft are antithetical to the 3R principles. Its operative provisions widen access to animals at the moment when India's own health ministry has been building the route away from them. Rule 4(6) returns animals to use in teaching laboratories that stopped using them more than a decade ago. Rule 5 creates exceptions for species protected under the Wildlife (Protection) Act, and for free-ranging and feral animals. Rule 21(2) permits sourcing from establishments that are not registered.

From 2011, the University Grants Commission phased dissection out of zoology and life sciences teaching. Enrolment had grown past a million students in courses requiring animals. Most animals used for teaching purposes were caught from the wild, and frog populations had declined to alarming levels. The guidelines barred frogs of the genus Rana and elasmobranch fish from laboratory exercises outright, both being protected under the Wildlife (Protection) Act, 1972.

Rule 4(6) of the draft reopens the question, permitting the use of animals for training and education, including vocational skills development. The need for this change is unclear, particularly as new technologies make teaching aids more relatable. Enrolment has not fallen, the sourcing problem is still the same, and the threat to biodiversity is still a possibility. The benefits of using novel technologies to teach anatomy to undergraduates are unlikely to be lower than the risks of returning to animal models for training.

Rule 5 goes further on experimentation with animals, at a time when global trends are moving towards non-animal models. Rule 5(1) creates exceptions allowing species protected under the Wildlife (Protection) Act to be used in experiments, and rule 5(3) allows exemptions for free-ranging and feral animals, based on an accepted scientific justification and permission from the relevant department. Rule 5(2)(c) would allow authorities to exempt researchers from the requirement to minimise suffering in wild animals injured during capture. The push for ease of doing research does not need to come at the cost of ecological disruption, particularly when the technologies that remove the need already exist. Rule 21(2) compounds the problem by permitting procurement from establishments that are not registered, and from open markets.

The call to reduce laboratory animal use is not driven by ethics alone. Animal models remain informative across much of conventional pharmacology, and cannot be substituted in easily. But they are a poor guide where the therapy is specific to human biology, as cell and gene therapies are. Animal studies are also slow and expensive. A cohort sourced from the open market carries variation the experiment cannot account for, which weakens the statistical power of the study and, in the testing of medicines and biological products, raises a biosafety question as well.

It is therefore not surprising that India in 2014 chose to move away from animal testing, when it became the first country in South Asia to ban animal testing for cosmetics. In 2023, the New Drugs and Clinical Trials (NDCT) Rules were amended to authorise the use of non-animal models for assessing novel drug safety and efficacy, espousing the 3R principle and moving apace with technologies to reduce animal use where possible. In August 2026, the government told the Rajya Sabha that the Indian Council of Medical Research had supported 109 projects on non-animal methods across 71 institutes and laboratories.

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It is this dichotomy in approaching animal experimentation that needs reconciling. One ministry is expanding the use of non-animal models in research. The other is widening access to animals, including protected wildlife, and loosening the conditions of their use.

This dichotomy cannot be settled by either ministry alone. The responsible use of animals for training and research has to be a balance between what is ethically right and scientifically useful. Getting this balance right, particularly as technologies advance rapidly, would require a whole-of-government approach, instead of a siloed one.

Naik is Chairperson of and Palo is Research Analyst at the Advanced Biology Programme, Takshashila Institution