- Draft rules, open for public comment until November 5, would let institutional ethics committees approve “mild” and “moderate” experiments on animals which currently need central approval under prevailing regulations.
- Animal rights groups say the rules weaken protections, citing a conflict of interest in approvals and subjective severity categories.
- The draft rules also open the door to using wild and stray animals in experiments, as well as sourcing livestock from open markets.
The draft Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules, 2026 issued by the government on September 30, 2026 has drawn sharp criticism from animal rights groups across the country, including PETA, which said they could “significantly weaken existing animal protections.” The draft rules are open to public comments till November 5, 2026.
The draft rules propose basing approvals for experiments on the expected severity of harm to the animal, departing from existing regulations — the Experiments on Animals (Control and Supervision) Rules, 1968, and the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 — which take a more centralised approach to which animals can be used for experimentation.
The draft rules allow institutional-level ethics committees to approve experiments of a “mild” and “moderate” nature, while deferring those of a “severe” nature or those from which the animal will not recover, to the central Committee for the Control and Supervision of Experiments on Animals (CCSEA). Prevailing regulations require approvals from the CCSEA for any experiments on animals above the phylogenetic level of rodents and other small animals, such as birds and rabbits.
“The draft rules list certain examples of experimentation — such as inducing tumours or solitary isolation — as being of a moderate nature. But these categorisations appear to be based on our perceptions of severity, and may not necessarily reflect whether it is mild, moderate, or severe on the animal per se,” says Surat Parvatam, Senior Program Director, Research and Toxicology, Humane World for Animals India.
The new draft rules also open the door to experimentation on wild and stray animals with permission from a “competent authority.”
In a statement, PETA India called the new draft rules “backward,” and said the government should be “strengthening the use of scientifically advanced non-animal approaches and animal-welfare protections, rather than weakening existing safeguards or creating new avenues for animal experimentation.”
What the rules propose to change
Any experimental study involving animals with a higher level of sentience than invertebrates require regulation under prevailing norms. The regulations require testing, trading, and breeding facilities to be registered with the Committee for the Control and Supervision of Experiments on Animals (CCSEA), under the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998.
Each facility must have a registered Institutional Animal Ethics Committee (IAEC) which is in charge of supervising such experiments and ensuring compliance with CCSEA guidelines. The IAECs are allowed to approve experiments for animals up to the phylogenetic level of rodents, including rats, mice, birds, and rabbits.
However, for animals of a higher phylogenetic level — such as dogs, goats, pigs, cattle, and monkeys — the IAEC can provide recommendations and must forward the proposal to the CCSEA for approval. Studies are based on the principles governed in the 1968 rules, which require they be done using a minimal number of animals and carried out “with due care and humanity”.
The new draft rules propose empowering the IAECs to approve experiments on all animals, as long as they are of a “mild” or “moderate” nature. Mild experiments are likely to cause short-term mild pain, suffering or distress, while moderate ones could cause moderate impairment of the well-being or general condition of the animals, as per the draft.
The CCSEA approval would be required only if experiments are of a “severe” nature, or from which the animal will not recover, and are performed on animals above the phylogenetic level of rodents or lagomorphs (hare-shaped mammals). Severe experiments could cause severe pain or impairment, or long-lasting suffering and distress, while “non-recovery” experiments “are performed entirely under general anaesthesia from which the animal shall not recover consciousness”, the draft rules say.
“A core mandate of the CCSEA is to oversee that unnecessary animal experimentation is not conducted. Outsourcing this decision-making to the IAECs introduces a conflict of interest because, as per the draft rules, five out of nine IAEC committee members are from the approving institute itself,” Parvatam says.
“An experiment should never be approved merely because an institution considers it useful or convenient. The availability of alternatives, the necessity of using animals, the severity of the procedure and the suffering involved must be taken seriously, says an objection letter drafted by the Rapid Response, a network of people who work with animals. It adds that where a suitable alternative exists, “animals should not be made to suffer simply because an institution chooses to proceed with animal testing”.
The introduction of the draft rules comes amid efforts from other arms of the government to diversify pre-clinical trial studies. In 2023, for example, the government passed its New Drugs and Clinical Trials (Amendment) Rules, 2023, which explicitly allow for organ-on-chip and new approach methods (NAMs) in drug safety and efficacy studies, neither of which require the use of animals in testing and experimentation.
Using wild and stray animals
The new draft rules do not strictly prohibit the use of wild or stray animals in experiments, saying, instead, that animals taken from the wild shall “not be used in experiments unless the Competent authority of the relevant department grants exemptions based on scientific justification”.
Stray and feral animals of domestic species too shall not be used except if “there is an essential need for studies concerning the health and welfare of the animals” or a scientific justification for their use. For livestock and other farm animals that cannot be procured from registered breeders, labs may procure them “from non-registered establishments or open markets with prior approval of IAEC,” the draft rules say, opening the door to commercial trade for experimentation.
“Lab-bred animals are used in experiments because of their genetic consistency. If animals are sourced from stray or wild populations, we don’t know their medical history or genetic background. How are you going to interpret the scientific data that emerges from the use of such animals?” Parvatam points out.
In 2022, the CCSEA issued a circular which allowed the use of stray dogs in clinical vaccine trials. The circular was withdrawn in October 2023 “till further orders.” CCSEA member secretary S.K. Dutta told The Hindu at the time that the order had been withdrawn because “it was not formulated how the vaccine trials will be done.”
Demand for animal experiments on the rise
The draft rules appear to follow a growing demand for pre-clinical trials in India. As of 2022, more than 2,300 facilities were registered with the CCSEA for conducting animal experiments using small and large animals.
A market research report by Grand View Research estimated the market for Contract Research Organizations (CROs) which conduct preclinical animal trials to be $183.3 million in 2023. It projected an annual compound growth rate of 11.4% between 2024 to 2030.
The report attributes the market growth to the increasing trends of outsourcing and R&D in clinical trials worldwide, rising technological advancements, the presence of a significant patient base, a substantial number of hospitals, and low operating expenses due to accessible and skilled human resources.
Banner image: A mouse in a laboratory. Representative image via Pixabay.
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