Will it become easier to experiment on animals in India? The Centre’s proposed overhaul of rules governing animal experimentation may possibly reduce the number of experiments requiring central regulatory approval, while permitting the use of certain animals that are otherwise barred, subject to specified exceptions, experts said.
The new draft Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules, 2026 – issued by the Committee for Control and Supervision of Experiments on Animals (CCSEA) under the Union ministry of fisheries, animal husbandry and dairying – proposes replacing the existing frameworks established under the 1968 and 1998 rules. The changes seek to simplify approvals for research institutions, universities and pharmaceutical and biomedical industries.
Animal welfare organisations have, however, raised concerns about the proposed shift in oversight, the classification of experiments according to the severity of pain, and provisions allowing exceptions to restrictions on the sourcing and type of animals used.
Who will approve animal experiments?
The biggest change proposed in the latest draft rules is a shift from the current approval framework to one based on how severe the expected harm to animals is.
Under the present rules, institutional animal ethics committees (IAECs) can approve experiments involving smaller animals, such as rodents and rabbits, while experiments involving larger animals generally require clearance from the central committee.
{{/usCountry}}Under the present rules, institutional animal ethics committees (IAECs) can approve experiments involving smaller animals, such as rodents and rabbits, while experiments involving larger animals generally require clearance from the central committee.
{{/usCountry}}However, under Rule 11 of the draft, experiments would be classified as “mild”, “moderate”, “severe” or “non-recovery”. IAECs would be able to approve mild and moderate experiments, including those involving animals of different sizes. Experiments classified as severe or non-recovery and involving animals above the rodent and lagomorph categories would require CCSEA approval following an IAEC recommendation.
The draft also requires IAECs to report on mild and moderate experiments involving animals larger than lagomorphs at three stages: at the beginning of the study, interim progress and completion.
Experts believe the shift could allow more experiments to be approved at the institutional level without being referred to the central committee. The classification itself has become a point of contention.
The draft’s Annexure-I places short-term solitary housing of adult rats or mice, deprivation of social partners, and exposure to stimuli associated with brief, avoidable mild pain or distress in the mild category. The moderate category includes certain tumour-induction studies, modified diets expected to cause clinical abnormalities and food deprivation for 48 hours in adult rats.
Experts said these categories matter because they determine which experiments can proceed without direct CCSEA approval. Gauri Maulekhi, trustee at People for Animals (PFA), said the draft appeared “disastrous in nature”, arguing that the three ₹of animal experimentation had been introduced in vague terms even as restrictions under the previous rules were being removed.
“The draft rules allow animal research for higher education and with pain graded into stages, institutes can decide for themselves the grade. So if the institution decides it is a mild or moderate grade, then they won’t need CCSEA approval and the exceptions are fairly vague,” she said.
Can wildlife, monkeys and stray animals be used?
The draft does not impose an absolute ban on using wildlife or animals obtained from the wild. Instead, it provides conditional exceptions.
Rule 5 says animals protected under the Wildlife (Protection) Amendment Act, 2022, cannot be used in experiments, except where specified conditions are met. These include scientific justification that the objective cannot be achieved using another species and permission from the competent authorities under applicable law. The provision excludes non-human primates from this exception.
Rule 6 separately permits experiments involving non-human primates under specified conditions, including where the research concerns certain serious or potentially life-threatening human health conditions, fundamental research or species conservation, and where the objective cannot be achieved using another species.
Animals taken from the wild may be used if the competent authority grants an exemption based on scientific justification that the objective cannot be achieved using animals bred for experimentation.
Similarly, stray and feral animals of domestic species are generally excluded, but exemptions may be granted for essential studies concerning animal health and welfare or serious threats to the environment or human or animal health, provided the objective can be achieved only by using such animals.
Maulekhi questioned the breadth of these exceptions, saying the provisions could permit experiments involving monkeys and that the restrictions on using stray animals were undermined by the exceptions.
The draft also allows certain livestock and agricultural animals, fish and birds to be sourced from non-registered establishments or open markets if they are unavailable from registered breeders or traders. Such procurement would require prior IAEC approval, documentation, and veterinary-certified quarantine and stabilisation in accordance with CCSEA guidelines.
Humane World for Animals India, an NGO, has also raised concerns that these provisions could compromise both animal welfare and the reliability of research.
“The new draft guidelines, by allowing the use of wild, stray and protected animals – under weakly defined clauses – can undermine credibility of scientific research and weaken the ethical safeguards that must underlie all scientific experimentation involving animals,” said Dr Surat Parvatam, senior programme director, research and toxicology, Humane World for Animals India.
The organisation argued that animals sourced from the wild, streets or undocumented breeders may have unknown medical histories, introducing variability that can undermine experimental reproducibility.
What are the three ₹and other safeguards?
The draft explicitly incorporates the principles of replacement, reduction and refinement – commonly known as the three Rs.
Replacement requires researchers to use scientifically satisfactory alternatives that do not involve live animals wherever possible. Reduction requires using the minimum number of animals necessary to obtain scientifically valid and statistically reliable results. Refinement seeks to minimise pain, suffering and lasting harm through better housing, care, veterinary practices and humane endpoints.
The draft also requires establishments to be registered with CCSEA, mandates veterinary supervision of experiments, and provides for institutional inspections, records and reporting. It prohibits experiments involving severe pain or distress that is likely to persist for a long period and cannot be alleviated.
However, animal welfare groups have questioned whether these provisions provide sufficient safeguards when decisions on a larger number of experiments are shifted to institutional committees.
Maulekhi also flagged the removal of what she described as the lifetime funding requirement for rehabilitation, a basic anaesthesia clause and restrictions on repeating experiments whose value is already known.
These concerns warrant scrutiny against the previous rules and their applicable guidelines to establish precisely which safeguards have been removed, altered or retained.
How does this compare with global testing?
Humane World for Animals India said several countries, including the US, the UK, members of the European Union, China and Brazil, were developing pathways towards reducing or phasing out animal studies and adopting human biology-based research technologies.
The organisation argued that India’s draft appeared to move in the opposite direction by widening the circumstances in which animals can be used and reducing central oversight.
The draft rules were published for public objections and suggestions on September 30. Responses were sought within 30 days of publication.