Constitutional Mandate for No‑Fault Compensation for Serious AEFI in State‑Led Vaccination Programmes
1. Introduction
Rachana Gangu v. Union Of India (2026 INSC 218, decided on 10-03-2026) arose from multiple proceedings
alleging deaths and severe injuries following COVID-19 vaccination—most prominently an Article 32 petition by parents
who lost two young daughters after vaccination, and several writ petitions pending before the High Court of Kerala.
A key procedural trigger was an interim order of the Kerala High Court in Sayeeda K.A. v. Union of India & Ors.
directing the Union to formulate a policy to identify AEFI cases and compensate families.
The Supreme Court heard: (i) the lead Article 32 writ petition (Rachana Gangu & Anr. v. Union of India & Ors.);
(ii) the challenge to the Kerala High Court’s interim directions; and (iii) transfer petitions to consolidate similar matters.
The Court framed the dispute not as a scientific adjudication on vaccine safety, but as a constitutional question of
institutional redress for grave harm alleged to have occurred in a State-led mass immunisation programme.
Key Issues
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Whether the absence of a uniform compensation policy for death/injury following COVID-19 vaccination violates
the Right to Life under the Constitution.
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If yes, whether the Supreme Court can direct the executive to frame such a policy.
2. Summary of the Judgment
The Supreme Court held that while it will not enter into scientific causality determinations in writ jurisdiction or create
a parallel expert body (given the existing National/State AEFI Committees), the absence of a structured, accessible
compensation framework for serious AEFI in the context of a State-led vaccination programme raises constitutional concerns.
The Court therefore issued a decisive institutional direction:
the Union of India, through the Ministry of Health and Family Welfare, must expeditiously formulate and place in the public domain an appropriate no-fault compensation framework for serious adverse events following COVID-19 vaccination.
Operative Directions (as crystallised by The Court)
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The Union of India shall frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination.
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Existing AEFI monitoring mechanisms shall continue, with AEFI-related data periodically placed in the public domain,
consistent with Jacob Puliyel v. Union of India.
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No separate court-appointed expert body is required.
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The judgment does not preclude other legal remedies; the no-fault framework is not an admission of liability/fault.
3. Analysis
A. Precedents Cited
1) Union Carbide Corpn. v. Union of India, (1 989) 3 SCC 38
Invoked to underscore that in extraordinary mass-harm situations, constitutional courts may catalyse relief without
impermissibly crossing into forbidden terrain. The Court referenced the Bhopal tragedy context to highlight that
institutional response to large-scale suffering is not alien to Indian constitutional adjudication, and that courts can
ensure immediate relief orientation while respecting domain boundaries.
Cited as part of The Court’s Article 21 “right to health” lineage. It supports the proposition that health and bodily integrity
are integral to life and dignity, enabling The Court to frame vaccine-injury redress as a constitutional welfare question—not
merely a private tort dispute.
Used to reiterate the established principle that the right to health is integral to Article 21 and that the Government has
a constitutional obligation to provide health facilities. The Court extends this “positive obligation” reasoning into the
pandemic vaccination context—arguing the State’s duty does not logically end at administering vaccines.
Reinforces that the State cannot disclaim obligations to provide medical facilities. This precedent strengthens The Court’s
normative foundation: constitutional health duties are not optional, and institutional arrangements must meaningfully
operationalise the right to life.
5) Distribution of Essential Supplies and Services During Pandemic, In re, 2021 SCC OnLine SC 372
Relied on to articulate the pandemic-era judicial posture: courts must recognise executive expertise in managing a public
health crisis yet remain vigilant against arbitrariness. This supported a restrained but real form of intervention—
i.e., directing the creation of a policy framework while avoiding scientific micro-management.
Cited (via the pandemic “In re” decision) for the proportionality-based review of pandemic policies, emphasising that
executive latitude is not a constitutional blank cheque. Here, the principle is transposed: a policy vacuum affecting
life and dignity can also trigger constitutional scrutiny.
This was the judgment’s central anchor on vaccine approval and AEFI surveillance. The Court quoted Jacob Puliyel to:
- Reject broad-brush claims that vaccine approvals were granted unlawfully or hastily.
- Affirm the existence of established AEFI monitoring and causality assessment mechanisms.
- Reinforce transparency duties—especially direction “144.8” requiring an accessible virtual platform for reporting suspected AEFIs and public accessibility of reports (with confidentiality safeguards).
In the present case, Jacob Puliyel served a dual function: it justified judicial restraint against setting up a new expert board,
and simultaneously supported a judicial mandate for transparency and participatory reporting—now supplemented by the
additional institutional layer of no-fault compensation.
Used as a precedent for directing executive authorities to frame guidelines for ex-gratia assistance in a mass-death context.
It enabled The Court to position the present direction (a no-fault AEFI compensation framework) as a legitimate constitutional
response to an exceptional public health calamity—while recognising policy design as primarily executive.
B. Legal Reasoning
1) Reframing the dispute: from individual causation to systemic redress
The Court carefully separated two questions:
(i) whether vaccines caused particular deaths (a scientific inquiry), and
(ii) whether the State must create an accessible remedy architecture when serious harm is alleged in a State-led vaccination programme.
It declined to conduct individual causality determinations in writ jurisdiction, but held that constitutional scrutiny remains
alive where a policy vacuum leaves affected families without a uniform pathway of relief.
2) Article 21 as a source of positive, institutional obligations
The Court reaffirmed that Article 21 is not merely a negative restraint against unlawful deprivation of life. It includes
the right to health and bodily integrity and imposes a positive duty on the State. In The Court’s reasoning,
when the State undertakes a massive public health intervention, the right to health “automatically extend[s]” to an obligation
of institutional support for grave outcomes, “no matter how rare”.
3) Why fault-based litigation is an inadequate sole remedy in vaccine injury cases
The Union argued victims could approach civil courts/consumer fora for negligence-based claims. The Court did not deny the
availability of those remedies, but held they are ill-suited as the only pathway because:
- Scientific attribution/correlation can be complex and contested.
- Requiring proof of negligence imposes an onerous burden on grieving families.
- Mass, fragmented litigation risks inconsistent outcomes and unequal access, raising Article 14 concerns.
4) No-fault compensation as a constitutional-welfare instrument
The Court invoked domestic analogies (notably Section 164 of Motor Vehicles Act, 1988) to demonstrate that Indian law already
recognises fixed, no-fault liability in categories requiring swift relief. It also surveyed international models (Australia, the
United Kingdom, WHO/COVAX, Japan) to show that vaccine injury compensation schemes are a common welfare-state response.
Crucially, The Court’s move is doctrinal: it constitutionalises the need to explore a no-fault framework for serious AEFIs in the
COVID-19 vaccination context, without converting the judgment into a finding of wrongdoing by the State.
5) Separation of powers: restrained intervention, not policy-making
The Court acknowledged that policy design lies with the executive, but held that separation of powers cannot eclipse the
judiciary’s constitutional duty when fundamental rights are compromised by executive action or inaction. The remedy was therefore
“calibrated”: a direction to formulate and publish a framework, while leaving the content, criteria, and operational details to
executive expertise.
6) Transparency and participatory reporting: reinforcing Jacob Puliyel
Addressing allegations of opacity, The Court reiterated the Union’s duty to ensure efficient AEFI surveillance and to place
relevant data in the public domain “in a transparent and timely manner,” aligning with the earlier direction in Jacob Puliyel v. Union of India.
7) Refusal to create a parallel expert body
The Court declined the request for an independent court-appointed board, finding the existing National and State AEFI Committees
adequate absent material showing they are non-functional or incapable. This reflects institutional respect for specialised
scientific mechanisms and avoids judicial duplication of technical decision-making.
C. Impact
1) A new constitutional baseline for mass public health interventions
The judgment establishes that where the State conducts a large-scale vaccination programme, Article 21 may require more than
surveillance and messaging: it may require a structured, accessible compensation framework for serious AEFIs, grounded in welfare
and dignity rather than fault.
2) Shift from ad hoc ex gratia to an institutionalised “no-fault” model
By ordering a no-fault compensation policy (not merely discretionary ex gratia), The Court elevates compensation from a matter of
benevolence to a rights-sensitive governance obligation—while still allowing the executive to define eligibility, quantum, and process.
3) Litigation and administrative practice
- Future courts may rely on this reasoning to scrutinise policy vacuums affecting health-related dignity, even when causation is scientifically contested.
- Administrative bodies will likely need to integrate AEFI surveillance outputs with compensation decision pipelines.
- Transparency duties around AEFI reporting platforms and publication of data are reinforced and may be more actively enforced.
4) Keeping private remedies intact
The Court’s clarification preserves tort/consumer claims, signalling a “both-and” model: no-fault baseline support plus the
possibility of fault-based damages where legally established.
4. Complex Concepts Simplified
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AEFI (Adverse Event Following Immunization): Any medical problem that happens after vaccination. Importantly, it may be coincidental and not necessarily caused by the vaccine.
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Causality assessment: A scientific process to decide whether the vaccine likely caused the event, based on evidence, timing, alternative explanations, and known side-effect profiles.
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No-fault compensation: Compensation that does not require the claimant to prove negligence or wrongdoing. It focuses on quick, fair support when serious harm occurs in a socially necessary programme.
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Writ jurisdiction limits (scientific questions): Constitutional courts can protect rights and require fair procedures, but typically avoid deciding specialised medical causation questions case-by-case.
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Separation of powers (calibrated remedies): Courts generally do not draft policies; however, they may direct the executive to create a policy when its absence undermines constitutional rights.
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Article 14 concern (equality): If relief depends only on who can afford prolonged litigation or which forum decides differently, similarly placed families may be treated unequally.
5. Conclusion
Rachana Gangu v. Union Of India marks a significant development in Indian public health constitutionalism:
it holds that in the exceptional context of a State-led mass vaccination programme, Article 21’s right to health and dignity
supports a constitutional expectation of institutional redress for serious AEFIs through a no-fault compensation framework.
At the same time, The Court maintained doctrinal discipline: it refused to become a scientific fact-finder, declined to create
a parallel expert board, and preserved the availability of private-law remedies. The precedent’s core takeaway is the
reconciliation it forges—judicial restraint in science, coupled with judicial insistence on rights-adequate governance.