Supreme Court’s No-Fault Vaccine Compensation Directive: Public Health Law and the Duty of Care

The Supreme Court of India’s landmark directive in the case of Rachana Gangu, instructing the Ministry of Health and Family Welfare to design a no-fault compensation scheme for serious Adverse Events Following Immunisation (AEFI) arising from India’s COVID-19 vaccination campaign, represents a paradigm shift in how the Indian state conceptualises its obligations toward citizens in state-run public health programmes. The editorial analysis in The Hindu of March 14, 2026 describes this judgment as marking a movement “from a fault-based liability system to a no-fault one,” setting an important precedent for future vaccination drives including the HPV vaccine programme.

The Rachana Gangu case originated from writ petitions filed by families claiming that their relatives died or suffered serious injury after receiving COVID-19 vaccines. The specific case involves the deaths of two young women, aged 18 and 20, in 2021, allegedly from Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT), a rare but documented complication of the Covishield (Oxford-AstraZeneca) vaccine. India administered approximately 219 crore doses of COVID-19 vaccines, with Covishield constituting the vast majority, and officially reported over 1,100 deaths following vaccination.

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This issue is of direct relevance to UPSC aspirants across multiple papers — it connects GS-II (government health policies, judiciary), GS-III (science and technology, public health), and GS-IV (ethics of state-run health interventions). It also raises fundamental constitutional questions about the right to life under Article 21.

Background and Context: Five Important Key Points

  • AstraZeneca acknowledged in a UK court document in 2024 that Covishield could, in rare instances, cause Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT), a serious clotting disorder — an admission that significantly undermined the Indian government’s earlier position that causal links between the vaccine and reported deaths were unproven.
  • In the Jacob Puliyel judgment of 2022, the Supreme Court had rejected challenges to emergency vaccine approvals but had emphasised the need to make AEFI data publicly available, laying the groundwork for the Rachana Gangu ruling by establishing transparency as a state obligation.
  • The Indian government had previously resisted establishing a compensation mechanism, arguing that vaccination was voluntary, serious AEFI rates were extremely low, and aggrieved citizens could pursue civil litigation against vaccine manufacturers — a position the Court rejected as impractical for ordinary citizens.
  • The global COVAX facility established a no-fault compensation mechanism for 92 low- and middle-income countries, meaning that India — despite operating one of the world’s largest immunisation programmes — was conspicuously absent from a global standard it was otherwise committed to.
  • Countries including the United States (through the National Childhood Vaccine Injury Act, 1986 and the Countermeasures Injury Compensation Program), the United Kingdom, Germany, and Japan have established no-fault vaccine injury compensation programmes where claimants need only demonstrate a plausible causal link rather than negligence.

The VITT Complication: Science Behind the Controversy

Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) is a rare but serious adverse reaction characterised by abnormal blood clotting combined with low platelet counts. It was first described in medical literature in early 2021, shortly after the rollout of adenoviral vector vaccines, specifically Covishield and the Janssen vaccine. The mechanism involves an immune response in which antibodies bind to platelet factor 4 (PF4), activating platelets and leading to simultaneous thrombosis and thrombocytopenia.

The reported incidence of VITT varies but is generally estimated at between 1 in 50,000 to 1 in 100,000 doses of adenoviral vector vaccines. While extremely rare, given that India administered hundreds of crore doses, even a small incidence rate translates into a substantial absolute number of cases. The medical literature had established this connection well before AstraZeneca’s 2024 court acknowledgment — the Supreme Court’s ruling thus brings Indian legal and policy standards into alignment with established scientific consensus.

Constitutional Foundation: Article 21 and the State’s Duty of Care

The Supreme Court’s ruling is grounded in Article 21 of the Constitution, which guarantees the right to life and personal liberty. The Court’s jurisprudence has consistently expanded the ambit of Article 21 to include the right to health (Parmanand Katara v. Union of India, 1989), the right to a dignified life, and the right to be free from arbitrary state action that endangers life. When the state actively promotes and administers a vaccination programme — even if formal coercion is absent — it exercises a form of soft compulsion through access restrictions, social mandates, and civic duty narratives. In such circumstances, the state cannot wash its hands of responsibility for serious adverse events by characterising vaccination as merely voluntary.

The Court’s ruling in Rachana Gangu explicitly held that for a welfare state, reported deaths following vaccination “represent individual human lives” and that the absence of a formal compensation policy “left affected families in a legal vacuum.” This articulation is a significant expansion of the jurisprudence on the state’s positive obligations under Article 21 — moving from prohibiting the state from taking life arbitrarily to requiring the state to actively protect against life-endangering consequences of its own programmes.

Institutional and Governance Dimensions

India’s existing vaccine pharmacovigilance system operates through the Adverse Events Following Immunisation surveillance framework, which is coordinated by the National Adverse Events Following Immunisation Surveillance and Response Cell under the Ministry of Health. The system relies on passive surveillance — reporting by healthcare providers — and is widely acknowledged to suffer from significant underreporting, partly due to the complexity of establishing causal attribution and partly due to institutional disincentives for reporting adverse events that might create vaccine hesitancy.

The no-fault compensation scheme directed by the Supreme Court will require a robust claims processing infrastructure. The scheme must define: what constitutes a “serious adverse event” eligible for compensation; what evidentiary standard claimants must meet to demonstrate a plausible causal link; what compensation quantum is appropriate; and how the scheme will be financed — whether through government appropriation, mandatory contributions by vaccine manufacturers, or a combination.

International Comparisons and Implications for the HPV Programme

The US National Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program (VICP), which has paid out over four billion dollars to claimants since its inception. The UK’s Vaccine Damage Payment Scheme provides a one-time tax-free lump sum payment. These schemes have not undermined vaccine confidence — on the contrary, evidence suggests that transparent compensation mechanisms can actually strengthen public trust in vaccination programmes by demonstrating that the state takes adverse events seriously.

The Supreme Court’s ruling will have direct implications for India’s HPV vaccination programme for adolescent girls, which is being expanded nationally. Given that the HPV vaccine is recommended for a specific age cohort — adolescent girls — and administered through government health facilities, the state’s duty of care is directly engaged. The compensation framework developed in response to the Rachana Gangu directive must be in place before large-scale HPV vaccination reaches its full operational scale.

Way Forward

The Ministry of Health and Family Welfare should urgently establish a dedicated expert committee to design the no-fault AEFI compensation scheme, drawing on international best practices from the US, UK, and the COVAX mechanism. The scheme should adopt a reverse burden of proof standard — once a claimant demonstrates that a serious adverse event occurred within a scientifically plausible post-vaccination window, the burden should shift to the state to demonstrate that the event was entirely unrelated to vaccination. A dedicated Vaccine Injury Compensation Fund should be created, with assured annual allocations. AEFI surveillance should be shifted from passive to active monitoring, with mandatory reporting by all healthcare providers under appropriate legal protection against retaliatory liability.

Relevance for UPSC and SSC Examinations

GS Paper II: Government health policies, the role of judiciary in policy-making. GS Paper III: Science and Technology — vaccine technology, public health. GS Paper IV: Ethics of state intervention in public health, duty of care. Essay: State Accountability in Public Health Emergencies. SSC Topics: General Awareness — health policies, Supreme Court judgments. Key terms: Rachana Gangu, AEFI, VITT, Covishield, Article 21, no-fault compensation, Jacob Puliyel judgment, COVAX, HPV vaccine, National Vaccine Injury Compensation Program.

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