Animal testing remains an important element of pharmaceutical research, vaccine development, and medical science in India. However, the proposed revision of regulations governing laboratory experiments has sparked a discussion on a fundamental question: can India optimize scientific research without weakening animal protection?
The draft Rules on Prevention of Cruelty to Animals (Control and Supervision of Experiments, Breeding, and Trade of Laboratory Animals) for 2026, released by the Committee for Control and Supervision of Animal Experiments (CCSEA), outlines changes in experiment classification and approval. Although it introduces a severity-based system for assessing animal suffering, animal welfare groups have expressed concerns regarding reduced regulatory oversight, the use of certain animal species, and potential conflicts of interest during institutional approval.
The discussion is also taking place against the backdrop of scientific advancements that offer alternatives to animal testing, including human cell research, organoids, organ-on-a-chip technology, and computer modeling. The question arises whether India's regulatory framework is keeping pace with these developments.
The proposed rules include several key aspects. Firstly, there is classification by severity: experiments are divided into four levels depending on expected pain or distress: Mild, Moderate, Severe, and Non-recoverable. Secondly, decentralized approval is provided: the institution's internal Animal Ethics Committee (IAEC) can directly approve mild and moderate experiments across all species. The central CCSEA retains the right to approve procedures classified as severe and non-recoverable, especially concerning animals above rodents and rabbits.
Thirdly, the 'Three Rs' principles—Replacement, Reduction, and Refinement—are being implemented. These principles mandate the use of alternatives wherever possible, limiting the number of animals to the scientifically necessary minimum, and improving procedures and care to minimize suffering. The proposed structure also establishes requirements for the registration of institutions, institutional ethics committees, veterinary supervision, trained personnel, and animal care facilities. Experiments may be conducted for specific purposes, such as basic and applied research, drug and food safety testing, disease research, environmental protection, and species conservation.
The experimental use of animals is not limited to pharmaceutical companies. Dr. Surat, Senior Director of the Research and Toxicology Program at Humane World for Animals India, noted that such studies are conducted in pharmaceutical and biotechnology companies, medical research institutions, universities, veterinary colleges, and government laboratories.
Animals are used in vaccine development and batch testing, food and feed safety assessment, disease research, and studying the efficacy of potential treatments. Tests can assess short-term and long-term toxicity, skin and eye irritation, carcinogenicity, and reproductive toxicity. Among the most commonly used laboratory animals are mice and rats, followed by rabbits, guinea pigs, fish, and birds; non-human primates are also used in some areas.
Nevertheless, quantifying the scale of animal experimentation in India is difficult. Dr. Surat reported that while between 100 and over 115 million animals are used annually in experiments and research worldwide, India lacks official national statistics or a transparent public database tracking annual animal usage, mortality, and registered violations.
Dr. Ramnuj Panda, founder and managing director of Gocarin, called for the creation of a centralized reporting system that would record the species of animals used, the severity of experiments, animal deaths, and welfare complaints.
Animal experimentation in India is governed by the Prevention of Cruelty to Animals Act of 1960. This act empowers the CCSEA to regulate experiments and ensure that animals are not subjected to unnecessary pain or suffering. Section 17 obligates the committee to guarantee the absence of unnecessary pain or suffering before, during, or after experiments. Section 18 permits inspections of facilities and verification of relevant records. Section 19 grants the committee the power to prohibit experiments if rules are violated, subject to established procedure.
The proposed rules will change the distribution of approval responsibilities, particularly concerning experiments related to mild and moderate levels of suffering.
One of the main issues raised by animal welfare organizations relates to provisions allowing certain experiments involving protected wild animals, wild-caught animals, and stray or domestic animals, provided certain conditions and permits are met. PETA India pointed to these provisions, arguing that capturing, handling, transporting, and housing animals not bred for laboratory use can cause stress and disrupt their natural behavior. The organization also questioned the scientific validity of using animals whose health status, genetic background, and environmental history may be unknown.
The organization expressed concern about the potential impact of laboratory use on domestic dogs and cats. It also referenced the CCSEA Circular of 2022, which permitted the use of stray dogs in some vaccine trials. This circular was withdrawn in 2023. Dr. Nupur Jain, Science and Research Policy Advisor at PETA India, stated: 'India must move towards modern, human-relevant science, not toward easing animal testing.'
PETA also argued that the severity level of the experiment, rather than the size or species of the animal, should determine the level of regulatory control.
Beyond animal use, the shift to institutional approval has raised questions about independence and potential conflicts of interest. Dr. Surat noted that five out of nine members of the IAEC belong to the same institution requesting approval for the experiment, raising concerns about how independent research proposals might be assessed.
There is a risk that institutions may approve mild and moderate experiments involving a wider range of species without prior CCSEA permission. This underscores the particular importance of the role of independent members, veterinary supervision, and clear scientific justification. Panda stated that simplifying approvals should not come at the expense of animal welfare. He called for significant involvement of independent members in IAEC decisions, mandatory veterinary supervision, documented scientific justification, and external reviews for high-suffering experiments.
The draft mandates inspections by designated nominees, including a socially aware member, at least twice a year. Separately, CCSEA inspector teams can audit facilities to confirm compliance. Dr. Surat added that facilities also undergo physical checks upon initial registration and every five years, and large animal research facilities require annual interim inspections.
Another issue is whether India could become a location for outsourcing animal research. Dr. Rukmini Jonnalagadda, founder and chief scientist of ULQA Scientific in Hyderabad, cited a 2026 investigation by the Irish publication The Journal, which found that Irish universities were commissioning animal experiments in foreign laboratories, including in India. Galway University disclosed payments of 102,174 euros to the Indian organization Presude Lifesciences for overseas research. The Irish Health Products Regulatory Authority confirmed that it has no regulatory role in animal experiments conducted abroad. The investigation does not establish that Indian research violated local rules, but it raises questions about how institutions commissioning overseas research assess and control animal welfare standards.
Animal models can provide valuable scientific information; however, interspecies differences can limit the accuracy of predicting human responses. Animals and humans may metabolize chemicals differently and possess different genetic, metabolic, immune, and physiological characteristics. Panda emphasized that animal research should not be considered proof that a drug or treatment will be safe for humans.
The clinical trial example of TGN1412 in 2006 is often cited—an antibody that showed safety in preclinical testing on non-human primates. During the first human trial, all six healthy volunteers who received the antibody developed severe immune reactions. Dr. Surat also pointed to gene therapy research for X-linked myotubular myopathy. Although the treatment showed promising results in dogs, human clinical trials were associated with serious liver complications and deaths. He also mentioned safety issues with Sarepta Therapeutics' Elevidys gene therapy for Duchenne muscular dystrophy, which received a warning letter from the U.S. Food and Drug Administration (FDA) due to severe liver damage. These cases do not mean that animal research lacks scientific value; they highlight the limitations of relying on animal studies as the sole predictor of human safety, especially with complex diseases and treatments.
New Approach Methodologies (NAMs) include cell assays, three-dimensional tissue cultures, organoids, organ-on-a-chip systems, and computer models. These methods allow researchers to study aspects of human biology without relying on live animals at every stage of testing. Organoids are miniature structures grown from cells that mimic specific features of human organs, while organ-on-a-chip systems replicate selected organ functions. Computer models can also help predict how substances might behave in the human body.
However, these methods cannot yet reproduce every interaction between organs, the immune system, and other biological processes in a whole organism. Therefore, they are used in conjunction with animal models in areas where complex biological interactions remain difficult to replicate.
India has taken some steps toward recognizing alternatives. Amendments to the Drugs and Clinical Trials Rules of 2023 recognized methods such as cell assays, organ chips, microphysiological systems, and computer modeling for relevant regulatory purposes. The government's response to parliament in 2026 highlighted support for 109 non-animal testing projects by the Indian Council of Medical Research across 71 institutions and laboratories. Nevertheless, experts believe that broader adoption requires investment in infrastructure, training, validation, and collaboration between researchers and regulators.
Dr. Surat argued that the draft rules must do more than just classify experiments by severity. India should consider stronger provisions to promote the development and validation of alternatives, including a requirement that animal procedures not be performed where a recognized non-animal method is available. The draft could be strengthened by requiring researchers to document the search for alternatives before applying for approval, publishing annual statistics on animal use, and establishing a national center for validating non-animal testing methods. Dr. Surat also pointed to ambiguity in defining a 'humane endpoint' in the draft—the point at which an experiment must be stopped to prevent further suffering. The expert believes the rules should establish a clear and actionable response when an animal reaches this stage. Panda stated that experiments involving prolonged suffering must be strictly controlled, with veterinary monitoring, adequate analgesia, and clearly defined humane endpoints. He added that the transition from routine animal testing...
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