‘Who will protect the animals?’: Maneka Gandhi slams draft rules easing lab trial approvals

India’s draft 2026 rules would change who approves experiments involving laboratory animals. The proposed system would give institutions more responsibility for authorising research conducted on their own premises. This matters because critics say internal approval could weaken independent protection for animals.

Under Rule 11, an institution’s ethics committee could approve experiments classified as mild or moderate, across animal species. The institution would also appoint the committee’s chairperson and member secretary. Experiments classified as severe would still be sent to the Committee for Control and Supervision of Experiments on Animals, or CCSEA.

The draft would replace the 1998 rules if finalised. People for Animals says the change could create a conflict of interest because laboratories would control approvals for their own research. The ministry says the rules are intended to protect animals and promote replacement, reduction, and refinement. The public has 30 days to submit objections and suggestions.

The Committee for Control and Supervision of Experiments on Animals, or CCSEA, is the central regulatory body overseeing animal experiments in India. Its role is to provide approval and central scrutiny for research involving laboratory animals. This oversight is intended to check whether proposed experiments meet regulatory and welfare requirements.

Since 1998, experiments on animals larger than rodents and rabbits have required CCSEA approval. The arrangement therefore covered experiments involving species such as dogs and primates, according to the concerns raised by People for Animals. The committee has served as an authority outside the individual institution conducting the research.

The draft 2026 rules would narrow the situations requiring CCSEA review. Mild and moderate experiments across species could be approved by an institution’s own ethics committee. Severe experiments would continue to require CCSEA approval. Critics fear this would reduce independent scrutiny, while the ministry presents the draft as a framework for protecting animals used in science and education.

The proposed change is broad because it is based on the experiment’s severity, not the animal species involved. Under Rule 11, institutional ethics committees could approve experiments classified as mild or moderate across species. That could include research involving animals larger than rodents and rabbits, such as dogs and primates.

The key mechanism is a two-level approval system. Mild and moderate experiments would be decided inside the institution conducting them. The institution would appoint the ethics committee’s chairperson and member secretary. Only experiments classified as severe would be referred to the central CCSEA for approval.

This differs from the system described as operating since 1998. Under that framework, experiments on animals larger than rodents and rabbits required CCSEA approval. People for Animals says the proposed arrangement could let institutions approve most experiments themselves. The ministry says the rules would establish protections and guide the authorisation of animal-use projects.

Independent oversight means that approval comes from a body separate from the institution conducting the experiment. If a laboratory’s own ethics committee approves its research, that separation becomes weaker. This matters because the committee would be judging work carried out by the same institution responsible for appointing key committee members.

The draft says the institution would appoint the committee’s chairperson and member secretary. People for Animals argues that this could give institutions complete control over approving experiments on their own premises. The organisation describes that arrangement as a possible conflict of interest, especially when animal welfare and institutional research goals may not align.

The likely concern is weaker scrutiny before experiments begin. The source does not establish that every internal committee would approve harmful work, but activists say accountability could be reduced. If the draft is finalised, mild and moderate experiments would generally avoid referral to CCSEA, leaving severe experiments as the category requiring central review.

The proposed sourcing rules could make animal histories harder to trace. People for Animals says laboratories might obtain animals from unregistered sellers and open markets when registered breeders are unavailable. The concern is not only where animals are bought, but whether their identities and origins can be reliably recorded.

The draft reportedly includes exemptions that could permit the use of stray and wild animals. Without a verifiable record for each animal, the organisation says it would be difficult to ensure that lost pets and community dogs do not end up in laboratories. This creates a direct animal-welfare and accountability concern.

The article does not state that these outcomes would definitely occur. It reports them as risks identified by activists in response to the proposed changes. If the rules are finalised with these provisions, reliable sourcing records would be especially important for tracking animals and preventing unsuitable or unlawfully obtained animals from entering research facilities.

Replacement, reduction, and refinement are three principles for limiting harm in animal research. Replacement means using non-animal methods instead of animals where possible. Reduction means using fewer animals while still obtaining useful results. Refinement means changing procedures, housing, care, or handling to reduce pain, distress, or suffering.

The draft refers to these principles and proposes guidelines for the replacement and reduction of animal use. It also covers refinement in breeding, accommodation, care, and use. These principles are intended to shape how projects are designed and how animals are bred, housed, treated, and euthanised.

The central issue is whether the principles will be followed in practice. People for Animals argues that weaker independent oversight could make enforcement less effective. The ministry says the proposed rules would establish measures for protecting animals used for scientific or educational purposes. The draft also provides for evaluating and authorising projects involving animals.

Governments and regulators are developing non-animal, human-relevant methods to reduce reliance on laboratory animals in drug testing. The article reports that the Union Health Ministry amended the New Drugs and Clinical Trials Rules in 2023 to allow new drugs to be tested using such methods. This signals official support for alternatives.

These methods could change research by allowing some testing to use approaches considered more relevant to humans, rather than relying on animals. The source does not list particular technologies or claim that animal testing has ended. It states that new drugs can be tested without animals under the amended rules.

This direction contrasts with concerns about making animal experiments easier to approve. People for Animals argues that regulators elsewhere are moving away from animal testing, while the draft could weaken independent oversight. If alternatives become more widely used, research could reduce animal use and align more closely with the draft’s principles of replacement, reduction, and refinement.