Self-Approval By Another Name: 2026 Draft Animal Testing Rules And PCA Act
Shreya Bajpai
1 Nov 2026 3:00 PM IST
In March 2023, the Health Ministry amended the New Drugs and Clinical Trial Rules to recognise non-animal testing methods. The Draft Rules now proposed by the Committee for Control and Supervision of Experiments on Animals (CCSEA) echo that commitment in words (Rule 3(1)). Whether that commitment is honoured, however, is left largely to the applicant's own answers on a form.
The draft brings real gains: a four-tier severity scale (Rule 7, Annexure-I), a bar on severe, long-lasting pain that cannot be ameliorated (Rule 7(2)), a co-signed euthanasia registry (Rule 15(4)(c)), three-yearly re-registration (Rule 23), and project-specific or immediate sanctions (Rule 25).
What it drops matters as much. The 2006 amendment required that animals lowest on the phylogenetic scale be considered first (Rule 9(bb)). The draft keeps a species test only for protected species and primates (Rules 5(1)(b), 6(1)(c)). It also omits the equivalent in EU Directive 2010/63/EU, Article 13(2)(b), though Rule 15(4) copies the next paragraph. For other animals, Schedule III asks why a species was chosen, but the only standard is that the approver be “satisfied” (Rule 11(6)). Nothing else secures Section 17(2)(e) of the PCA Act, which requires that larger animals be avoided where smaller ones would suffice.
The deeper problem is structural. The draft borrows the Directive's exemptions without its independent authorisation. It lets in-house committees classify severity and then approve accordingly. It leaves severe work on rodents and rabbits with no approver. And it keeps a stray-animal exemption that one circular could turn against court-sheltered dogs. Each defect can be cured by targeted amendment.
Borrowed Text, Missing Architecture
Much of the draft is lifted almost word for word from EU Directive 2010/63/EU. What was copied, and what was not, is the clearest evidence of the problem.
Copied into the draft | Left Out |
Rule 1(4)(d): The rules provide for “the evaluation and authorisation of projects” (Art. 1(1)(d)) | Articles 36-45: The Evaluation and authorisation process itself. |
Rule 2 definitions of breeder, establishment, project, trader, user (Art. 3(2)-(6)). | Article 3(7): The definition of “competent authority”. |
Exemptions for wild-caught, injured and stray animals: Rules 5(2)(a), 5(2)(c), 5(3) – (Arts. 9(2), 9(3), 11). | Article 38(2)(e): assessment of those justifications in project evaluation; Article 59: designation of who decides. |
Death as an endpoint: Rule 15(4) (Art. 13(3)) | Article 13(1)-(2): No procedure where a recognized alternative exists; use of species with the lowest capacity to suffer. |
Four-tier severity scale: rule 7, Annexure-I (Art. 15, Annex VIII) | Article 38(2)(c): severity assigned by the authority, not the establishment. |
In the Directive, the exemptions cannot operate alone. Every project needs prior authorisation after an impartial evaluation by the competent authority. That authority assigns severity, weighs harm against benefit, and assesses any justification for using wild or stray animals (Arts. 36, 38). The draft keeps the exemptions and none of this. Rule 13(2)(b) even requires projects to run “in accordance with the project authorisation”, which nothing in the draft creates.
Article 42's simplified procedure is no answer: it is optional, excludes primates, and still requires Article 38 evaluation. The Directive's in-house body only advises (Arts. 26-27), whereas Rule 11(3) gives in-house committees final approval over all mild and moderate experiments, for every purpose and species.
The missing definition compounds this. Rules 5(2)(c) and 5(3) invoke a competent authority with no anchor, where the 2006 amendment named “the authority competent under the law for the time being in force”. India need not follow the EU, but the draft's own text assumes an authorisation system it never creates.
Self-Classification and the Approval Vacuum
Severity now decides who approves an experiment, and the establishment decides severity. It classifies each case (Rule 7(1)), and the IAEC's internal veterinarian certifies the result (Rules 11(10), 16(2)). Under the Directive, the competent authority assigns severity (Art. 38(2)(c)). No Schedule records the classification, so CCSEA cannot audit the label that fixes the approval route. Vague entries such as “minor surgical experiments (with anaesthesia)” also leave room to classify downward.
That room matters. Under Rule 11(3), mild and moderate experiments on every species go to the IAEC alone and “shall not be referred” to CCSEA. CCSEA receives only post-approval reports for larger animals and minutes for rodents and rabbits (Rules 11(4), 17(5)). In-house approval of rodent work dates to 1998; extending it to dogs and other large animals departs from current procedure. Section 17(2)(a) of the PCA Act makes the institution's head responsible for experiments, but responsibility for compliance is not authority to approve.
The committee offers little resistance. The establishment picks the chair and member secretary (Rule 16(4)). A quorum of six needs only two CCSEA nominees (Rule 17(2)). Because the link nominee attends only in the main nominee's absence (Rule 17(3)), internal members outnumber nominees five to three even at full strength. There is no conflict-of-interest, recusal or voting rule.
The sharpest defect sits at the top of the scale. Rule 11(2) sends severe and non-recovery experiments to CCSEA only for animals “above the category of rodent and lagomorph”; Rule 11(3) gives the IAEC only mild and moderate work. Nothing designates an approver for severe work on rats, mice and rabbits. That gap covers routine toxicology and surgery with post-operative pain, which Annexure-I classes as severe. Either the IAEC fills it by default, so the most severe work gets the least outside scrutiny, or such work cannot lawfully proceed at all. Deleting one phrase from Rule 11(2) fixes both.
From Shelters to Lab Benches
In In Re: “City Hounded by Strays, Kids Pay Price”, the Supreme Court held that dogs picked up from restricted-access institutional premises must be sterilised, vaccinated and sheltered rather than released. The result is a growing population held under court directions.
Rule 5(3), copying Article 11 of the Directive, bars the use of stray and feral animals of domestic species. But it lets “the competent authorities” grant exemptions where, among other grounds, there is a serious threat to human or animal health and only a stray will serve. The judgment treats rabies and dog bites as such a threat; a vaccine study on sheltered dogs could cite that very finding.
Whether a sheltered dog is still a “stray” is left to an undefined authority. The Directive excludes strays partly because capture increases their distress (Recital 21), a reason stronger still for dogs already confined. In the EU, such a dog would also face Article 10's purpose-breeding rule and Article 38 evaluation. The draft copies only Article 11.
The Ministry may answer that Rule 21(1), limiting acquisition to registered sources, makes Rule 5(3) unworkable. If so, it faces a dilemma: either Rule 5(3) is inoperable and surplus, or it overrides Rule 21(1) and is dangerous. Either way, it should go.
Nor is a dormant exemption safe. Because Rule 2(j) treats any CCSEA direction as a “Guideline”, a circular naming a “competent authority” could activate Rule 5(3) without Gazette notification. In September 2022, CPCSEA told laboratories that stray dogs could be used for vaccine trials, withdrawing that only “till further orders” in October 2023. Such a circular would be challengeable under Section 17(1)'s previous-publication requirement, but the 2022 one stood for over a year.
So, what lies ahead?
The Draft Rules, 2026 need not be withdrawn wholesale; its structural gains, from severity scales to euthanasia registries, deserve preservation. Bridging the administrative gap between its scope clause and substantive text requires closing Rule 11(2)'s approval vacuum by deleting “above the category of rodent and lagomorph,” restoring CCSEA's exclusive authority over all severe and non-recovery protocols. Central prior authorisation under Rule 11(3) must likewise be restored for all large animals, including dogs, cats, primates, and livestock, regardless of severity. CCSEA must also be empowered to audit severity declarations, while IAECs require enforceable recusal and conflict-of-interest rules.
Aligning the draft with Section 17 of the PCA Act demands stripping out Rule 5(2)(c)'s executive waiver of the duty to minimise animal suffering. Vocational training under Rule 4(6) and curriculum approvals under Rule 11(11) must be strictly conditioned on recorded findings that no non-animal alternative suffices, barring animal use merely to acquire manual skill. Finally, Rule 5(3)'s stray exemption must be deleted or barred from applying to community dogs and court-sheltered animals.
References
G.S.R. 175(E), New Drugs and Clinical Trials (Amendment) Rules, 2023.
https://egazette.gov.in/WriteReadData/2023/244322.pdf
G.S.R. 864(E), Prevention of Cruelty to Animals (Control and Supervision of Experiment, Breeding and Trading of Laboratory Animals) Rules, 2026 “Draft Rules”.
Directive 2010/63/EU of the European Parliament and of the Council, of 22 September 2010 on the protection of animals used for scientific purposes, “EU Directive”.
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF
S.O.1818(E), “Breeding of and Experiments on Animals (Control and Supervision) Amendment Rules, 2006”, “2006 Amendment”. https://ccsea.gov.in/WriteReadData/userfiles/file/2006.pdf
The Prevention of Cruelty to Animal Act, 1960, “PCA Act”.
LiveLaw, “'Dog Bite Menace Rising': Supreme Court Refuses To Modify Directions To Remove Stray Dogs From Public Places” — In Re : 'City Hounded By Strays, Kids Pay Price', SMW(C) No. 5/2025, 2026 LiveLaw (SC) 515 https://www.livelaw.in/pdf_upload/2026/06/13/2026-livelaw-sc-515-in-re-city-hounded-by-strays-kids-pay-price-v-state-of-andhra-pradesh-19-may-2026-679563.pdf
“Central panel withdraws circular on conducting vaccine trials on stray dogs”, The Print, 12 October, 2023.
Author is an early-career researcher in Law and Policy and a practicing Advocate. Views are personal.
