Experiments on animals set to become easier

New Delhi: The Centre has proposed a major regulatory overhaul of animal experimentation, seeking to reduce the Maneka Gandhi-era central oversight to fast-track approvals for academic and research bodies as well as the pharma and biomedical industry.

The draft proposes a radical shift, allowing registered institutional ethics panels to approve the bulk of experiments, instead of requiring clearance from the Central Control and Supervision of Experiments on Animals (CCSEA) committee.

The draft also proposes a new, globally attuned four-tier clearance based on the "severity" of pain caused to animals, instead of the currently prevalent physical size-based classification. Central oversight will essentially be restricted to the top-tier "severe" pain experiments, as per the proposed rules.

Simplifying rules

The draft rules seek to simplify, consolidate and supersede two older rulebooks - The Experiments on Animals (Control and Supervision) Rules, 1968, and The Breeding of and Experiments on Animals (Control & Supervision) Rules, 1998 - the latter brought in when then Union minister Maneka Gandhi chaired the Central CCSEA, then known as CPCSEA.

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The 1998 rules gave the committee debatable powers, such as compulsory registration of biomedical research facilities, new ethical norms, provisions for unannounced inspections, ban on animal dissections in schools, etc, which sparked considerable backlash.

AFTER CONCERNS

Now, the draft rules attempt to undo some of that with a deregulation and ease-of-doing-business approach, triggered after top scientific and biomedical institutes and industry set-ups reportedly red-flagged delays in obtaining approvals from CCSEA even for smaller-scale experimentation.

Currently, the Institutional Animals Ethics Committees (IAEC) is empowered to approve only experiments involving "small animals" like rodents, mice, birds and rabbits. Experiments involving larger animals like dogs, goats, pigs, cattle and monkeys are required to be taken to CCSEA for approvals.

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The draft Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules, 2026 - issued by the Ministry of Fisheries, Animal Husbandry and Dairying - now propose a new "risk-based" classification of experiments to determine if a particular animal experiment requires CCSEA authorisation or can be addressed at the institutional level through registered IAECs.

The four-tier "risk-based" classification - mild, moderate, severe and non-recovery - is based on the "degree of pain, suffering, distress or lasting harm" expected to be experienced by the animal.

IAEC will be permitted, as per the draft rules, to approve experiments only where the animal may suffer no more than "mild" or "moderate" levels of pain or impairment.

The "mild" category includes observational/behavioural studies, superficial experiments, short-term solitary caging, administration of anaesthesia, etc. The "moderate" experiments may include minor invasive techniques, induction of tumours, creation of genetically altered animals through surgical experiments and so on.

IAEC will have to ensure a three-stage reporting to CCSEA and submit minutes within 15 days. It will have to hold regular meetings with a quorum of six members, including the main nominee and socially aware nominee. High-containment laboratories will also be subject to mandatory annual audits, digital data logging, euthanisation registers and other norms.

The new regime embeds replacement, reduction and refinement - aimed at minimising discomfort to animals - under Rule 3, making them enforceable and syncing with global best practices. The proposed rules formally define domestic and foreign 'contract research' and 'collaborative research', giving legal clarity to the biotechnology and pharma industry.