From rats to monkeys, strict new rules for lab animal testing

The Centre has proposed new rules to regulate animal experiments based on the pain, distress and suffering they may cause. The draft introduces four severity categories, strengthens approval requirements for severe procedures and adopts the 3Rs principles of animal research.

Hyderabad: Experimenting on animals in scientific laboratories across multiple locations is set to come under much stricter oversight as regulatory authorities have now decided to overhaul the entire framework.

Moving away from the archaic rules that judged oversight based purely on an animal’s physical size, the updated regulations center entirely on the actual degree of pain, distress, and suffering endured by the animal during testing.

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The Committee for Control and Supervision of Experiments on Animals (CCSEA), under the Union Ministry of Fisheries, Animal Husbandry, has recently released a comprehensive draft framework—the Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules—aimed at modernising scientific accountability and closing regulatory loopholes.

Historically, India’s regulatory oversight was heavily dependent on a creature’s physical footprint, i.e., its size. Bureaucratic hurdles for experiments on large animals like dogs or monkeys were notoriously stringent. However, permissions to conduct lab experiments on smaller-sized animals like rats were always quick because the regulators did not consider the amount of pain and distress actually caused by the experiment in the laboratory.

Under the new upcoming framework, the system of permitting animal experiments will transition to a strict, case-by-case four-tier severity scale classification.

The first category involves non-recovery experiments performed entirely under general anesthesia, from which the laboratory animal does not wake up. The second category involves mild procedures that cause short-term, minimal pain or distress in the laboratory animal without significantly impairing its well-being.

The third classification consists of moderate interventions causing short-term moderate or long-lasting mild pain, and severe protocols that inflict intense, severe, or long-lasting pain and critical impairment.

While the rules empower local Institutional Animal Ethics Committees (IAECs), which are the in-house committee of the scientific laboratory, to independently greenlight mild and moderate experiments in all animal species to reduce red tape for routine studies, there are much tighter regulatory laws around high-impact testing.

Any experiment classified as severe, or any procedure involving animals higher than rodents and lagomorphs (rabbits and hares) that does not result in recovery, will mandatorily require direct clearance from the central committee.

Importantly, the new regulatory rules for animal experiments adopt the global scientific standard of the 3Rs, including Replacement, Reduction, and Refinement. This means that it is mandatory for the researchers involved in the animal experiments to actively seek alternatives to live animals, minimize the number of creatures used, and maximize pain-mitigating care through anesthetics and analgesics.

New animal experiment rules:

New pain-based metric, as oversight shifts from an animal’s size to its degree of pain and suffering during an experiment

Four tier-based severity scale categorised as non-recovery, mild, moderate and severe protocols

Ethical committee within the laboratories can independently greenlight routine mild and moderate animal studies

Centralised gatekeeping, as severe animal experiments and high-impact procedures will require permission from the central committee.

It is mandatory for lab scientists involved in animal experiments to explore humane non-animal alternatives

Scale of animal experiments in India:

Hyderabad is one of the largest pharmaceutical and biotech epicenters

There are 120 registered animal testing and research facilities in Telangana

Close to 2, 300 animal testing labs throughout the country

Globally, a total of 115 million animals are used in laboratory experiments

In US and India, vast majority of animals are rodents (mice, rats, fish)