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What India’s draft lab animal rules say, rule by rule

By Animal Writes ·

On the Gazette of India published draft rules, G.S.R. 864(E), to replace the 1968 and 1998 rules on experiments on animals. The Committee for Control and Supervision of Experiments on Animals (CCSEA) invites objections and suggestions within thirty days. This is what the main rules say.

Rule 11: who approves an experiment

Rule 11(3) says experiments classed as mild or moderate, “including such experiments on all animals”, go to the establishment’s own Institutional Animals Ethics Committee (IAEC) for decision, and “shall not be referred to the Committee”. Rule 11(2) sends only severe and non-recovery experiments on animals above rodents and rabbits to CCSEA, which must decide within thirty working days.

For mild and moderate experiments on animals above rabbits, Rule 11(4) makes the IAEC report to CCSEA at three stages: start, interim progress and completion. The draft does not say who approves severe experiments on rodents and rabbits.

Rule 21(2): where animals come from

Animals must come from CCSEA-registered breeders or traders (Rule 21(1)). If a kind of livestock or farm animal above rabbits, or fish or birds, is not available from them, Rule 21(2) allows buying from “non-registered establishments or open market” with the IAEC’s prior approval, records and a quarantine set by CCSEA guidelines.

Rule 5: strays, wild animals and protected species

Stray and feral animals of domestic species “shall not be used”, but “the competent authorities may grant exemptions” where there is an essential need and scientific justification (Rule 5(3)). The draft does not define “competent authority”. Wild-caught animals need an exemption from the relevant department (Rule 5(2)). Species protected under the Wildlife (Protection) Amendment Act, 2022 can be used only for listed purposes, with justification and permission (Rule 5(1)).

Rule 6: primates

Primates can be used for serious human disease, basic research or preserving the species, where no other species will do (Rule 6(1)). Primates listed in the Wildlife (Protection) Amendment Act, 2022 “shall not be used” (Rule 6(2)). Rule 5(1)(c) says the protected-species rule “shall not apply to any species of non-human primates”, which leaves the position unclear.

Rule 2(i): what counts as a lab

An “establishment” includes “a place that is not wholly enclosed or covered and mobile facilities”.

Rule 7 and Annexure I: the pain scale

Each experiment is classed as non-recovery, mild, moderate or severe. Annexure I lists food withdrawal for under 24 hours in adult rats and short-term solitary caging of sociable rats and mice as mild, and 48-hour food withdrawal and stimuli the animal cannot escape as moderate. Rule 7(2) bars experiments with severe pain “likely to be long period” that “cannot be ameliorated”.

Rules 4(6) and 11(11): teaching

Higher education and professional training are permitted purposes. An IAEC can approve repetitive or curriculum-based teaching for up to five years.

Rule 25: penalties

CCSEA can suspend or revoke an establishment’s registration after a deficiency notice. The fine in Section 20 of the Prevention of Cruelty to Animals Act stays at up to ₹200; rules cannot change it.

Objections can be sent to CCSEA until . Write and send yours in two minutes.

Read the full draft in our Library.

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