What Happened
- In Rachana Gangu v. Union of India (2026 INSC 218), a bench of Justices Vikram Nath and Sandeep Mehta directed the Union of India to formulate and place in the public domain a "no-fault compensation framework" for serious Adverse Events Following Immunisation (AEFI) from Covid-19 vaccines.
- The Court found that India does not have a uniform or structured policy mechanism to provide redress for vaccine adverse effects, calling this gap one that "cannot be lightly overlooked, particularly when vaccination programmes are undertaken as public health measures under the aegis and authority of the State itself."
- Under the directed framework, citizens would not need to prove negligence or fault on the part of vaccine manufacturers or government — compensation would be available on proof of the adverse event itself.
- The Court clarified that formulating the no-fault framework shall not be construed as an admission of liability by the Union or any authority, and does not bar other legal remedies.
- The Union was also directed to continue robust AEFI surveillance and place relevant data in the public domain transparently and in a timely manner.
Static Topic Bridges
No-Fault Compensation in Public Health: Concept and Global Precedents
No-fault compensation schemes for vaccine injuries are designed to remove the burden of proving medical negligence from claimants — a burden that is practically difficult to discharge given the complexity of establishing causation between a vaccine and an adverse health outcome. Countries with established no-fault vaccine compensation programmes include the United States (National Childhood Vaccine Injury Act, 1986, which created the National Vaccine Injury Compensation Program — VICP), the United Kingdom (Vaccine Damage Payments Act, 1979), and most Scandinavian countries. The rationale is based on social contract theory: the state promotes mass vaccination for herd immunity and collective public health benefit; individuals who suffer rare adverse events as part of this collective effort deserve state-backed compensation without litigation. Prior to this Supreme Court direction, India lacked a statutory no-fault compensation scheme for vaccine injuries, with claimants limited to consumer courts, civil suits, or writ petitions — all of which require proof of negligence or deficiency of service.
- USA's VICP has paid over $5 billion in compensation since 1989 for vaccine injuries and deaths. [Unverified: exact current cumulative figure]
- India's Drugs and Cosmetics Act, 1940 governs the approval and regulation of vaccines but does not contain a specific compensation mechanism for immunisation injuries.
- AEFI (Adverse Event Following Immunisation) is the technical term; not all AEFIs are causally linked to the vaccine — they may be coincidental events temporally associated with vaccination.
- WHO's AEFI classification includes: vaccine product-related reactions, vaccine quality defect-related reactions, immunisation error-related reactions, immunisation anxiety-related reactions, and coincidental events.
Connection to this news: The Supreme Court's direction fills a critical regulatory gap in India's public health architecture, requiring the government to establish a defined, transparent framework for AEFI compensation — moving India toward international best practices in vaccine governance.
Constitutional Right to Health and State Liability in Public Health Programmes
The right to health has been read into Article 21 (Right to Life) by the Supreme Court in a series of judgments, including Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996), which held that the state has an obligation to provide medical treatment to citizens. In the context of mandatory or state-encouraged vaccination campaigns, the Court's reasoning in the present case extends this principle: if the state encourages or mandates vaccination for public health, it bears a corresponding duty of care toward those who suffer serious adverse consequences. The Directive Principle in Article 47 additionally places on the State a duty to raise the level of nutrition and the standard of living and to improve public health.
- Article 21 — Right to Life encompasses the right to health (Paschim Banga Khet Mazdoor Samity case, 1996).
- Article 47 (DPSP) — State shall endeavour to raise the level of nutrition and the standard of living and to improve public health.
- Article 39A — Equal justice and free legal aid (relevant for ensuring compensation access to poor victims).
- Doctrine of Strict Liability vs. No-Fault: no-fault compensation does not require proving the manufacturer acted below standard of care; strict liability imposes liability without fault for abnormally dangerous activities.
Connection to this news: The Supreme Court grounded its direction in the state's constitutional duty of care arising from Article 21, holding that when citizens participate in a state-sponsored mass vaccination programme, the state cannot be indifferent to serious harm suffered as a consequence.
India's Covid-19 Vaccination Programme and AEFI Monitoring
India's Covid-19 vaccination programme — one of the largest in world history — administered over 220 crore vaccine doses, primarily Covishield (AstraZeneca-Oxford/Serum Institute of India), Covaxin (Bharat Biotech/ICMR), and later Corbevax, ZyCov-D, and Covovax. AEFI surveillance was conducted through a national AEFI reporting system under the Ministry of Health and Family Welfare, with district-, state-, and national-level AEFI committees reviewing serious events. Despite this infrastructure, the Court found the existing system inadequate for providing binding compensation to serious AEFI victims, particularly those with causally linked severe outcomes such as vaccine-induced immune thrombocytopenia and thrombosis (VITT) associated with some adenovector vaccines. [Unverified: specific VITT case numbers in India reported under the national AEFI system.]
- India administered over 220 crore Covid-19 vaccine doses (Covishield, Covaxin, Corbevax, ZyCov-D, Covovax).
- AEFI monitoring: National AEFI Committee under MoHFW reviews serious/severe adverse events.
- Covishield: manufactured by Serum Institute of India; based on ChAdOx1 (adenovirus vector) platform.
- Covaxin: developed by Bharat Biotech with ICMR; whole virion inactivated virus platform.
- VITT (Vaccine-induced Immune Thrombocytopenia and Thrombosis) — rare but serious adverse event linked to adenovector vaccines globally.
Connection to this news: The Court's direction to publish AEFI data transparently alongside creating a compensation framework addresses a dual gap: India must both compensate affected individuals and build public trust by openly accounting for vaccine adverse events.
Key Facts & Data
- Case: Rachana Gangu v. Union of India (2026 INSC 218) — bench of Justices Vikram Nath and Sandeep Mehta.
- Direction: Formulate no-fault compensation framework for serious AEFI from Covid-19 vaccines; Ministry of Health and Family Welfare to implement.
- India administered over 220 crore Covid-19 vaccine doses during the pandemic.
- No-fault principle: compensation without proving negligence or fault — burden of proof shifts to establishing causal adverse event only.
- Court: Framework shall not be construed as admission of liability by Union or manufacturers.
- Comparative: USA's VICP (1986), UK's Vaccine Damage Payments Act (1979) — established global precedents.
- Constitutional anchors: Article 21 (Right to Health), Article 47 (DPSP — public health duty).
- AEFI = Adverse Event Following Immunisation; classified by WHO into 5 categories.