The Supreme Court has directed the Union government, in Rachana Gangu v. Union of India (2026), to frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination.
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About the Vaccine Injury Compensation Mechanism
- Definition: A policy framework that provides financial compensation to individuals who suffer serious adverse effects following immunisation, usually through a no-fault system that does not require proof of negligence by the State or manufacturer.
- Objective: To ensure timely and equitable redress for vaccine-related injuries while maintaining public confidence in national immunisation programmes.
Reasons for the requirement of a Vaccine Injury Compensation Mechanism
- Rare but real adverse effects: Serious adverse events such as anaphylaxis, thrombosis with thrombocytopenia syndrome (TTS), vaccine-associated paralytic polio, and encephalopathy have been documented despite vaccines being overwhelmingly safe.
- Scale of vaccination: India administered over 219 crore COVID-19 vaccine doses, making even rare adverse reactions significant in absolute numbers.
- Recorded Adverse Events Following Immunisation (AEFI) cases: The government’s recent affidavit in court recorded 92,114 Adverse Events Following Immunisation (AEFI) cases, including 89,332 minor, 2,782 serious or severe AEFIs, and 1,171 deaths.
- Social contract argument: Citizens accepted vaccination partly as a civic duty and therefore, the State must assume responsibility for rare harms arising from public health programmes.
- Limitations of Existing Legal Remedies:
- Tort Law Constraints: Tort claims require proof of negligence by the manufacturer or the State.
- However, many vaccine injuries arise from individual immune responses rather than fault, leaving victims without a viable cause of action.
- Consumer Protection Act, 2019 Limitations: Claims are difficult when vaccines are provided free of cost, as the existence of a ‘consumer’ relationship is disputed and consumer forums lack expertise in pharmacovigilance assessment.
- Inadequacy of Public Interest Litigation (PIL): PILs can direct policy formulation but cannot establish or administer an individual compensation mechanism, resulting in the absence of a uniform redressal system.
Constitutional and Legal Basis
- Article 21 (Right to Life): The Constitution does not merely permit the State to run vaccination programmes, but creates an affirmative obligation to protect public health as part of the right to life under Article 21, which includes the right to health.
- Doctrine of Legitimate Expectation: When the State mandates or strongly promotes interventions for collective welfare, it has a corresponding obligation to compensate individuals who suffer harm as a result of such measures.
- The “doctrine of legitimate expectation” supports this, as citizens who comply with State health directives may legitimately expect not to be abandoned if compliance causes injury.
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Significance of Establishing a Vaccine Injury Compensation Mechanism in India
- Building Public Trust: Strengthens confidence in vaccination programmes through transparency, accountability, and assurance of support in rare cases of harm.
- Promoting Equity and Social Justice: Ensures fair compensation for affected individuals, particularly poorer citizens who cannot easily access complex legal remedies.
- Facilitating Future Immunisation Drives: Encourages wider participation in upcoming vaccination programmes, such as India’s large-scale HPV vaccination initiative.
International Practices
- United States: Vaccine Injury Compensation Program with a dedicated “vaccine court.”
- United Kingdom: Vaccine Damage Payment Scheme with lump-sum payments.
- Other countries: Japan, Germany, New Zealand, the Nordic countries, Taiwan have no-fault compensation frameworks.
Way Forward
- Vaccine Injury Compensation Act: A statutory framework enacted by Parliament rather than an executive circular.
- Vaccine Injury Table: Presumptive causation list linking specific conditions to vaccines within defined time windows.
- Independent tribunal: Quasi-judicial body with medical and legal experts to adjudicate claims.
- Dedicated compensation fund: Jointly financed by the government and vaccine manufacturers through a levy system.
- Stronger AEFI surveillance: Transparent, disaggregated reporting and public dashboards for monitoring vaccine safety
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Conclusion
A robust vaccine injury compensation framework would balance the imperatives of collective public health protection with individual justice, ensuring that the costs of rare adverse events are not borne by affected individuals alone.
17 Apr 2026
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