The petitioners' daughters died within days of vaccination during the national drive; their years-long litigation sought accountability, disclosure of adverse-event data and compensation. The constitutional tension was real: the vaccination programme was the pandemic's lifeline, yet rare, serious adverse events following immunisation (AEFI) are a documented reality that India's framework, unlike many countries', answered with no dedicated compensation scheme.
The Key Question Before the Court
When a mass public-health programme produces rare serious injuries, must the State compensate without proof of fault — and can courts attribute individual deaths to vaccines?
The No-Fault Principle
The Court's direction adopts the architecture used by mature immunisation programmes worldwide: where a serious adverse event or death follows vaccination and fits the recognised injury framework, compensation is paid on a no-fault basis — the family need not prove negligence in design, manufacture or administration. The logic is both equitable and epidemiological: society collectively gains from mass vaccination, so society — not the unlucky family — should carry the cost of its rare casualties. The Union was directed to frame the policy accordingly.
What the Court Would Not Do
Equally deliberate was the restraint: the Court refused to legally attribute the petitioners' daughters' deaths — or any individual death — to the vaccines, leaving causation in each case to the medical and AEFI assessment machinery. A judicial declaration of vaccine-caused death, made without the science resolved, would have armed misinformation against immunisation itself; the judgment compensates vulnerability without convicting the vaccine.
What the Court Actually Ordered
- The Union is to frame a no-fault compensation policy for serious adverse effects and deaths following COVID-19 vaccination.
- No judicial attribution of individual deaths to the vaccines; causation remains for medical assessment within the framework.
Why This Judgment Matters
- It fills the oldest gap in India's immunisation law — the absence of a vaccine-injury compensation scheme.
- The no-fault design spares grieving families the impossible burden of proving negligence against the State.
- Its restraint protects public confidence in vaccination while acknowledging its rare costs.
- The framework will outlast COVID — a template for all mass immunisation programmes.
What Should Advocates Take Away From the Judgment?
For Affected Families
- Claims proceed on the injury profile and the AEFI record — preserve medical documentation; negligence need not be proved under the directed policy.
For the Union and Health Administrators
- Frame the policy with clear injury tables, timelines and an accessible claims process — the direction's value lies entirely in its administration.
Key Takeaways
- A no-fault compensation policy for serious COVID-vaccine AEFI is directed.
- Families need not prove State negligence to be compensated.
- Courts will not declare individual deaths vaccine-caused.
- The framework sets the template for future immunisation programmes.
Frequently Asked Questions
That eligibility turns on the injury and its recognised association with vaccination — not on proving anyone's negligence; the scheme pays because the harm occurred within the programme.
No — it expressly declined to attribute individual deaths to the vaccines, leaving causation to medical assessment while directing the compensation framework.
The Union, as the author of the national vaccination programme, was directed to frame the policy covering serious adverse events and deaths.
Conclusion
The judgment holds two truths without letting either destroy the other: vaccines saved the many, and the law must still answer to the few — with compensation that blames no one and abandons no one.
Practical takeaway: Vaccine-injury claims now travel through the no-fault framework — build the medical record, not a negligence case.
Read the full judgment: Rachana Gangu & Anr. v. Union of India & Ors. — (2026) 03 SC CK 1400 →
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