On March 11, 2026, a Supreme Court Bench comprising Justices Vikram Nath and Sandeep Mehta directed the Union government, through the Ministry of Health and Family Welfare, to frame a no-fault compensation policy for serious adverse events following COVID-19 vaccinations. The judgment arose from petitions seeking compensation for deaths and disabilities caused by Adverse Events Following Immunisation (AEFI) from COVID-19 vaccines. The Court’s finding was unequivocal: India does not have any uniform or structured policy mechanism to provide redress to individuals who suffer adverse effects following vaccination, and this gap “cannot be lightly overlooked, particularly when vaccination programmes are undertaken as public health measures under the aegis and authority of the State itself.”
The factual backdrop is significant. A total of 219.86 crore doses of COVID-19 vaccines were administered in India up to November 19, 2022. Of these, 92,114 AEFI cases were reported — representing 0.0042% of doses — and 1,171 deaths were reported as potentially linked to vaccination. The government had argued that these numbers were extremely low, but the Court held that even if the individual percentage is small, the absolute numbers are large enough to require a systematic compensatory framework, particularly given the compulsory or near-compulsory nature of the vaccination drive.
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For UPSC aspirants, this judgment is simultaneously a polity topic (judicial review of welfare-state obligations), a science and technology topic (vaccine regulation), and a health policy topic (public health emergency governance).
Table of Contents
Background and Context
Five Important Key Points
- India conducted the world’s largest COVID-19 vaccination drive, administering 219.86 crore doses up to November 2022, covering both the CoviShield (AstraZeneca-Oxford vaccine manufactured by Serum Institute of India) and Covaxin (developed by Bharat Biotech in partnership with ICMR) vaccines, among others.
- The Supreme Court observed that no-fault compensation schemes for vaccine injury are a recognised feature of welfare-state response globally, with the rationale that certain categories of harm require swift relief without prolonged inquiry into fault — a principle fundamentally different from tort-based liability.
- Countries including the United States (National Childhood Vaccine Injury Act, 1986, establishing the National Vaccine Injury Compensation Program), the United Kingdom, Germany, Japan, and Australia operate statutory no-fault vaccine injury compensation frameworks that pay compensation regardless of proven negligence by the manufacturer or the state.
- The Court specifically held that “the relationship between the individual and the State cannot be viewed through the prism of fault-based liability” in the context of vaccination campaigns carried out as collective societal necessities, creating a new doctrinal basis for welfare obligations.
- The Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules, 2019, regulate vaccine approval in India but contain no provision for post-approval compensation for AEFI deaths, creating the regulatory lacuna that the Supreme Court has now directed the government to fill.
Constitutional and Legal Framework
The Supreme Court’s direction is grounded in a cluster of constitutional provisions. Article 21 — the right to life and personal liberty — has been expansively interpreted by the Court since Maneka Gandhi vs Union of India (1978) to include the right to health. In Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996), the Court held that the State has an obligation to provide adequate medical facilities, and failure to do so violates Article 21. Article 47, a Directive Principle, obligates the State to raise the level of nutrition and the standard of living and to improve public health. Together, these provisions create the constitutional foundation for the Court’s reasoning that individuals who suffer harm from State-mandated vaccination programmes have a claim that cannot be reduced to proof of negligence.
The doctrine of no-fault liability itself has constitutional antecedents in Indian jurisprudence. In M.C. Mehta vs Union of India (Oleum Gas Leak case, 1987), a Constitution Bench established the principle of absolute liability — that enterprises engaged in hazardous activities are absolutely liable for harm caused, without the escape hatch of proving the exercise of reasonable care. While vaccine manufacturers are distinct from industrial enterprises, the underlying moral logic is similar: where the State compels or strongly encourages participation in an activity that carries some risk of harm, the State must stand behind the consequences.
Global Comparative Framework
The comparative dimension of this judgment deserves careful analysis. The United States’ National Childhood Vaccine Injury Act of 1986 created the Vaccine Injury Compensation Program (VICP), funded through an excise tax on vaccines, which has paid over $5 billion in compensation since its establishment. The UK has the Vaccine Damage Payment scheme. Germany’s Infection Protection Act provides statutory compensation. Japan has operated a no-fault scheme since 1976.
Common features across these schemes include: no requirement to prove manufacturer or government negligence; a published Vaccine Injury Table listing presumed compensable injuries; a specialised adjudicatory process (typically a vaccine court or tribunal); and funding through either general government revenue or a dedicated levy on vaccine manufacturers. India’s task, as directed by the Supreme Court, will be to design a scheme that is administratively feasible within India’s public health system, legally consistent with existing tort and criminal law frameworks, and financially sustainable given the scale of India’s vaccination programmes.
Policy Design Challenges
Designing India’s no-fault vaccine compensation policy presents several governance challenges. First, the question of causation: many AEFI cases are temporally but not causally related to vaccination. A compensation scheme must establish a clear and scientifically defensible Vaccine Injury Table that defines which conditions, occurring within specified timeframes after specified vaccines, will be presumed to be causally related to vaccination. Second, the question of financing: whether the scheme will be funded entirely by the government, partially by vaccine manufacturers, or through a dedicated levy requires policy decisions with significant fiscal implications. Third, the question of adjudication: whether AEFI compensation claims will be decided by a specialised tribunal, the consumer forum, or a dedicated health ombudsman requires institutional design choices. Fourth, the question of quantum: determining appropriate compensation levels for temporary disability, permanent disability, and death requires actuarial analysis.
Way Forward
The government should act swiftly on the Supreme Court’s direction by constituting a multi-stakeholder expert committee including public health specialists, legal experts, actuaries, and civil society representatives to design the compensation framework. The scheme should adopt the Vaccine Injury Table approach, drawing on the Brighton Collaboration’s global standards for AEFI causality assessment. Funding should be shared between the government and vaccine manufacturers through a dedicated cess on vaccine procurement. A specialised Health Claim Tribunal at the district level, with appellate jurisdiction vested in the High Court, would provide accessible and expert adjudication. The framework, once designed for COVID-19 vaccines, should be extended to all Government of India immunisation programme vaccines in a phased manner, starting with universal immunisation programme vaccines.
Relevance for UPSC and SSC Examinations
UPSC: GS Paper II — Government Policies in Health, Judiciary (Supreme Court Directives, Writ Jurisdiction, PIL). GS Paper III — Science and Technology (Vaccine Regulation, Biotechnology). Essay Paper — Public health as a fundamental right.
SSC: General Awareness — Indian Polity, Health Policies, Supreme Court, COVID-19 Vaccination Drive.
Key Terms: No-Fault Liability, AEFI (Adverse Events Following Immunisation), Article 21, Article 47, National Childhood Vaccine Injury Act 1986 (US), Drugs and Cosmetics Act 1940, New Drugs and Clinical Trials Rules 2019, Absolute Liability (MC Mehta case), CoviShield, Covaxin, Brighton Collaboration, Vaccine Injury Compensation Program (VICP), Universal Immunisation Programme.