Kolkata: The Centre’s draft rules governing animal experimentation have raised concerns among animal rights groups, which warn that the proposed changes could weaken independent oversight, increase the scope for self-regulation and make it easier for laboratories to conduct experiments on animals. While officials maintain that the amendments are aimed at simplifying approvals for research institutions, pharmaceutical companies and the biomedical industry, critics argue that the changes could undermine existing safeguards for laboratory animals. A crucial change to animal experimentation, proposed in the draft, is that mild and moderate experiments could be approved by an institution’s own ethics committee rather than going to the central regulator.
Animal rights activist and former Union minister Maneka Gandhi, in an interview to HT, said this would transfer significant decision-making powers to the very institutions seeking permission to conduct the experiments.
Explaining the implications of the proposed change, Gandhi who has worked on animal experimentation regulation for decades said the shift would remove an important layer of independent scrutiny. Under the existing framework, experiments involving animals larger than rats are subject to central regulatory oversight, providing an external check on whether a proposed experiment is necessary.
Under the draft rules, however, institutions could approve a substantial proportion of experiments through their own ethics committees. She argued that researchers, their colleagues and departmental heads would effectively be responsible for approving experiments conducted by their own institutions, creating a potential conflict of interest.
The concern is particularly significant because mild and moderate experiments account for a large share of animal experimentation, she said, warning that the proposed system could accelerate approvals and potentially lead to an increase in the number of animals used in laboratories.
The draft also classifies experiments as mild, moderate, severe and non-recovery, with the classification determining the level of scrutiny required. Critics have questioned whether institutions conducting the research should also be responsible for deciding the severity category of their experiments.
According to Gandhi, this arrangement could encourage experiments to be placed in lower-severity categories, allowing them to avoid independent regulatory review. The interview cited examples of procedures classified as mild or moderate, including short-term food deprivation, keeping social animals in isolation and subjecting animals to distress. Testing herbal products and established drugs, as well as procedures described as having “known and reversible effects”, were also highlighted as areas of concern.
She argued that the classification system could leave considerable discretion in the hands of institutions seeking approval, weakening the effectiveness of safeguards intended to protect animals from unnecessary suffering.
Another major concern relates to the proposed exceptions allowing laboratories to obtain animals from open markets and unregistered sources, as well as, under certain circumstances, use stray, feral, wild and protected animals with permission from a competent authority.
Gandhi warned that relaxing sourcing requirements could undermine traceability, which is one of the primary purposes of using registered animal breeders. Allowing laboratories to procure cattle, goats, birds and fish from unregistered sources could create demand that encourages the capture or collection of animals from poorly monitored channels.
The proposed exceptions have also raised concerns about whether community dogs, lost pets and animals taken from the wild could end up in laboratories. She questioned the absence of a clear definition of the “competent authority” responsible for permitting the use of such animals.
Arguing that the exceptions should be removed, she said laboratories should not be permitted to conduct experiments if they cannot obtain animals from registered sources.
She said India should accelerate the transition towards non-animal testing methods, pointing to changes in the country’s drug-testing framework that have allowed certain non-animal methods to be accepted. Such approaches, she argued, can in some cases predict human responses more effectively than animal models.
The proposed rules should require researchers to demonstrate that no validated alternative is available before using animals, she said. The government should also establish a national body to validate and promote alternative testing methods, allocate funding for their development and introduce timelines to phase out animal experiments in areas where reliable alternatives already exist.
Merely including replacement as a guiding principle in the rules would not be sufficient without mandatory requirements and mechanisms to enforce compliance, she added.
Calling for a comprehensive overhaul of the draft, she said the proposed framework should be reconsidered rather than amended in its current form. A fresh set of rules should be developed through consultations involving independent scientists, animal welfare organisations and legal experts.
The new framework, she argued, should strengthen existing legal protections for animals instead of diluting them in the name of simplifying regulatory procedures.
The central concern, therefore, is whether the proposed changes can streamline research approvals without compromising independent oversight, animal welfare and the accountability of institutions conducting experiments.
