RACHANA GANGU v. UNION OF INDIA
Constitutional Obligation of the State to Formulate a No-Fault Compensation Framework for Serious Adverse Events and Deaths Following COVID-19 Vaccination Under Article 21.
Court: Supreme Court of India
Citation: 2026 INSC 218
Decision Date: 10-03-2026
List of Laws
The Constitution of India, Articles 14, 19, and 21; Directive Principles of State Policy, Articles 41 and 47; The Drugs and Cosmetics Act, 1940; Administrative Law - Separation of Powers; Tort Law - Principle of No-Fault Liability; Public Health Policy and Vaccine Governance
- Facts: The petitioners are parents and family members of individuals who allegedly died or suffered grave injuries, such as Cerebral Venous Sinus Thrombosis and Thrombotic Thrombocytopenia, shortly after receiving COVID-19 vaccinations. They contended that the State failed to ensure informed consent, failed to warn about known risks like Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT), and lacked a transparent mechanism for monitoring Adverse Events Following Immunization (AEFI). The Union of India maintained that vaccinations were voluntary, the regulatory approval process was rigorous, and that existing AEFI surveillance committees were sufficient for causality assessment, noting that most deaths had no proven link to the vaccine.
- Procedural Posture: A writ petition was filed directly in the Supreme Court under Article 32. Simultaneously, several petitions were filed in the Kerala High Court, which had issued an interim order directing the government to formulate a compensation policy. The Union of India challenged that interim order via a Special Leave Petition and sought the transfer of all related High Court matters to the Supreme Court. All matters were clubbed together for a final determination.
- Issue: Does the absence of a structured, uniform policy for compensating individuals who suffer serious adverse events or death following a State-led mass immunization program violate the Right to Life and Health under Article 21? Furthermore, can the Court direct the State to frame a no-fault compensation policy?
- Holding: Yes. The Court held that the State’s obligation to safeguard the right to health includes providing an accessible redressal mechanism for grave outcomes arising from a national public health intervention. The Court directed the Union of India to formulate a no-fault compensation framework.
- Reasoning: The Court reasoned that while it would not sit in scientific review of vaccine efficacy or regulatory approvals, the Constitution does not view the Right to Life solely through the lens of fault. Under Articles 21, 41, and 47, the State has a positive obligation to provide institutional support to those harmed during a mass vaccination drive undertaken for collective societal necessity. Relying on the principle of "No-Fault Liability", the Court noted that requiring families to prove negligence in complex scientific matters is an "onerous burden" and "ill-suited" for mass programs. International precedents in Australia, the UK, and Japan further supported the necessity of an expeditious, no-fault avenue for relief to ensure the right to health remains meaningful rather than theoretical.
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