The Committee for Control and Supervision of Experiments on Animals recently published the Draft Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules, 2026. These rules lay down the laws for using animals in experimentation, including guidelines for reduction and replacement of animals, their breeding, care, accommodation and import, and regulations for breeders and users.These rules supersede the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998, and apply to all forms of basic and translational research across the sectors of drugs, food and feed and other substances or products.While the new rules aim to establish measures to protect animals used for scientific or educational purposes, several gaps have instead emerged that not only stretch the ethical boundaries of conducting research, but also compromise scientific credibility, reliability and reproducibility.Wildlife too can now be used for experimentsStarting from defining the infrastructure where laboratory animals are bred, housed, traded or used for experiment, the current rules include places that are “wholly enclosed or covered and mobile facilities”. This revised definition may thus include covered or open sheds without fully enclosed walls, vehicles, trailers or mobile units – all of which raise serious concerns regarding temperature, sanitation, secure biological and hazardous containment and waste disposal, ultimately compromising not just scientific research but also public health and safety.Animals protected under the Wildlife (Protection) Amendment Act, 2022 may also be used for research according to the draft rules, if justification can be provided that the experiment cannot be achieved using species other than the endangered species. However, protected species often belong to small, fragmented or declining populations, already facing conservation threats.Also read: Beware: Businesses Are Killing Biodiversity And This Threatens People And Economies, Says UN ReportThis underlines the critical need to view the use of protected animals not just through the lens of scientific objectives, but also to assess its widespread conservation and ecological consequences. For example, the population size of keystone species is known to have disproportionate impact on stability and resilience of ecosystems.There is a now a provision that allows the use of wild animals, stray and feral species, and animals from unregistered breeders, if justification can be provided for their use. However, scientific research is built on the pillars of reliability and reproducibility. Using animals from the wild, stray animals or unregistered breeders provide an unknown canvas of medical history, genetic mutations and background – virtually rendering this research unusable to arrive at any scientific conclusion.It has also been documented that the capture of animals from the wild is highly stressful for them and carries an elevated risk of injury and suffering during capture and transport, again impacting the biology and scientific integrity of research stemming from the use of such animals.Conflicts of interest, ethical concernsThe earlier law required all animal experimentation to be reviewed and approved by the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory body established under the Prevention of Cruelty to Animals Act, 1960 (PCA), to regulate animal experimentation.However, the new rules classify animal experimentation into “mild”, “moderate” and “severe” (irrespective of their phylogenetic status), and transfers the approval of “mild” and “moderate” categories to the Institutional Animal Ethics Committee (IAEC). This committee includes five out of the nine members from the same establishment that is applying for the approval of animal experiment – raising valid concerns regarding conflict of interest.The ‘Annexure’ file of the draft rules provides limited scenarios for “mild”, “moderate” and “severe” categories and includes several questionable compartmentalisations. For example, short-term deprivation of social partners, solitary caging of sociable strains, exposure to noxious stimuli, withdrawal of food for 48 hours, induction of tumours, irritation and chemotherapy are categorised into the “mild” or “moderate” categories.Also read: What Moral Philosophy Teaches Us About Eliminating Drug Tests on Animals in IndiaThis would mean that establishments could receive approval to perform experiments on similar use cases across the phylogenetic spectrum, including dogs, pigs, goats and non-human primates from IAEC, raising significant ethical concerns.Globally, the United States, the United Kingdom, the European Union, China and others are phasing out animal studies, releasing roadmaps and dedicated investment to transition towards human biology-based New Approach Methods (NAMs).The US has established a $400 million funding programme to advance these technologies, and China recently launched the Pilot Programme for Advancing Research and Application of New Methods (NAMs) (Pioneer Programme) to promote the research and application of NAMs.Last year, National Institutes of Health (NIH, US), reaffirmed its commitment to develop NAMs by announcing that it would stop funding proposals that exclusively rely on animal models.File photo: Scientist and study director Jennifer Molignano uses an electronic pipette to prepare culture medium, a dark pink fluid that provides nutrition to living human skin tissue, as she sets up a demonstration of experiments at a MatTek Corporation lab, in Ashland, Mass., on January 15, 2020. Photo: AP/Steven Senne.Undermining India’s progressAs the world continues to prioritise and incentivise 21st-century science that is human-relevant and precise, India has an opportunity to develop the skills, infrastructure and technology that will make it a key global player in the field of human-relevant NAMs.Several initiatives exist in India, including the New Drugs and Clinical Trials (Amendment) Rules, 2023, which allows the use of human biology-based test methods to test drug safety and efficacy; the ICMR’s funding towards 109 research NAM projects across 71 labs/institutes; the formation of NAM working groups at Indian Pharmacopeia Commission and Bureau of Indian Standards to develop National Standards for NAMs in India.However, the Draft PCA Rules 2026 undermine the progress India has made in the last few years. CCSEA was constituted under the PCA to prevent unnecessary animal experimentation. However, these rules increase the scope of animal use, disincentivise the use of human-relevant models and push against global harmonisation and modernisation of scientific research and testing.This would undermine the credibility of scientific research and weaken the ethical safeguards that must underlie all scientific experimentation involving animals.The Draft Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules, 2026, is open for public comments until November 5, 2026.Dr. Surat Parvatam is a senior program director of research and toxicology department at Humane World for Animals India. She holds a PhD in Cell Biology from the Tata Institute of Fundamental Research, Mumbai, and has led policy and research initiatives promoting human-relevant technologies in India. Her current work focuses on regulatory reforms to reduce animal testing, and she is also a science writer covering science policy, the environment and research.