A draft notification proposing a change in rules covering experimentation on animals has come in for criticism, with animal welfare voices urging the Centre not to proceed with the present version of the draft, that they say dilutes the scope and role of the existing regulatory framework.

The “draft rules are inconsistent with the (Prevention of Cruelty to Animals) Act, dilute several protections currently in force, and shift control over experiments from the statutory regulator to the establishments that conduct them,” said Gauri Maulekhi, Trustee and Member Secretary, People for Animals Public Policy Foundation, in her letter to Dr Sujit Kumar Dutta, Member Secretary with the Committee for Control and Supervision of Experiments on Animals (CCSEA), and ministers helming the apex Ministry of Fisheries, Animal Husbandry and Dairying.

Animal experimentation rules affect not just the user institutions and industry, “but also the animals the Act exists to protect, the scientific community and the public,” she said, of the draft issued on September 30, with a month for public comment.  

The draft has triggered public reactions, including emails to the CCSEA and tweetathons involving individuals posting their opposition on microblogging site X (formerly Twitter).

The CCSEA draft notification comes at a time when multiple global drug regulators, including the United States Food and Drug Administration, explore more non-animal methods in drug research.  

“The most serious structural defect in the Draft Rules is that the establishment that wishes to use animals, often for commercial benefit, becomes the body that decides whether it may do so. Five of the nine IAEC (Institutional Animal Ethics Committee) members are the establishment’s own staff, and the Draft Rules permit the Chairperson to be chosen from among them,” the letter said.

The letter urged authorities to keep pace with science, and come up with a fresh draft prepared in consultation with all stakeholders - independent scientists, experts in non-animal methods, veterinarians, animal welfare organisations and other subject matter experts.

The draft rules under Section 17 of the PCA Act, 1960, seek to supersede the Experiments on Animals (Control and Supervision) Rules, 1968 and the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998, (amended in 2001 and 2006).

Electric shocks, induced tumors

Another voice calling for withdrawal of the draft rules is the People for the Ethical Treatment of Animals India (PETA India). “Wild animals taken from their natural habitats, community dogs and stray cats potentially used in laboratory experiments, and animals subjected to electric shocks, induced tumors, and other severe suffering: these are among the alarming possibilities raised by India’s proposed animal experimentation rules,” it said.

Concerned that the draft could open the doors for experimentation on wild animals and community animals, Dr Anjana Aggarwal, PETA India’s Scientist and Research Policy Advisor, said, “India’s forests must not become a source of animals for laboratories, and our community dogs and cats must never be treated as disposable experimental subjects.”

Besides, “at a time when scientists can study human organs on chips, grow human tissues in laboratories, and predict toxicity using sophisticated computer models, India must move forward, not backwards,” she said, urging the government to withdraw the draft.

Urging authorities to build on the headway they made replacing animal with non-animal teaching and training methods, Peta said, globally too, “the US Food and Drug Administration is advancing the replacement of specified animal tests with human-relevant methods; the US National Institutes of Health is increasing investment in non-animal research technologies; and the US Environmental Protection Agency continues to expand the use of non-animal methods. The European Commission has adopted a roadmap towards phasing out animal testing for chemical safety assessments, while the UK government has set out a strategy to phase out the use of animals in science in all but exceptional circumstances.”

When contacted by businessline, pharma and research industry representatives said, they did not want to comment on the said draft notification.

Narrow scope

The PFA letter said, the existing draft narrowed the scope of protection that the Act ensured. For instance, the Act defined “animal” as “any living creature other than a human being…yet the Draft Rules apply only to vertebrates,” Maulekhi said, adding that it excluded entire categories of activity, including veterinary field trials and “any practice judged to cause less harm than a needle, a judgment left in practice to the establishment,” the letter says.  

The draft places responsibility on premises instead of persons, contrary to the Act, making it difficult to prohibit or prosecute, the letter said. It “divests the committee of the control Parliament gave it,” the letter alleges, as the final authority now becomes “the establishment’s own Institutional Animal Ethics Committee …”

The draft makes obligations into guidelines, the letter said, adding that experiments on animals above rodents and lagomorphs required the Committee’s prior approval, subject only to narrow exceptions. Now, “mild and moderate experiments on dogs, cats, farm animals and primates would no longer come before the Committee,” it said, adding that safeguards allowing rejection of a protocol if a non-animal alternative is available, has also been set aside, among other things.  

Published on October 21, 2026