Supreme Court Directs India to Frame a No-Fault COVID-19 Vaccine Compensation Policy

India administered over 220 crore doses of COVID-19 vaccines between January 2021 and 2023, one of the largest immunisation drives in human history. For the vast majority of recipients, the experience was uneventful. For a small but documented number, it was not.

In March 2026, the Supreme Court of India took formal note of what it described as the absence of any "uniform or structured policy mechanism" to provide redress to individuals who suffered serious adverse effects following COVID-19 vaccination. In Rachna Gangu and Anr. v. Union of India, a bench of Justices Vikram Nath and Sandeep Mehta directed the Ministry of Health and Family Welfare to formulate a no-fault compensation framework for serious Adverse Events Following Immunisation, commonly referred to as AEFI, arising from COVID-19 vaccines administered during the national immunisation programme.

The Court also directed that AEFI-related data be placed in the public domain on a periodic basis.

What Is a No-Fault Compensation Framework and Why Does It Matter

A no-fault compensation scheme, in the context of vaccine injury, is a mechanism through which an individual who suffers a serious adverse event following vaccination can receive financial relief without being required to prove that the vaccine manufacturer or the administering authority was negligent or at fault.

In conventional tort law, a person seeking compensation for injury must establish that another party was responsible, that their conduct fell below an acceptable standard of care, and that this conduct directly caused the harm suffered. In the context of vaccine-related injury, this burden is exceptionally difficult to discharge. Proving that a specific vaccine caused a specific adverse outcome, to the standard required in civil litigation, often demands highly specialised medical evidence, costly expert testimony, and extended legal proceedings, outcomes that are beyond the practical reach of most affected individuals.

No-fault schemes address this gap by separating the question of entitlement to relief from the question of fault. An eligible claimant need only establish that they received the vaccine and that they suffered a recognised adverse event within a specified time window. The scheme then provides a defined compensation without requiring the individual to sue the manufacturer or the State.

This model has been adopted in a number of countries with advanced vaccine programmes. The United States operates the National Childhood Vaccine Injury Act programme through the Court of Federal Claims. The United Kingdom has a Vaccine Damage Payment Scheme. Several European Union member states maintain comparable mechanisms. India has no equivalent national framework at present, which is precisely what the Supreme Court has now directed the government to create.

The Rachna Gangu Case: How It Reached the Supreme Court

The petition in Rachna Gangu and Anr. v. Union of India was filed on behalf of individuals who suffered serious adverse events following the administration of COVID-19 vaccines under India's national vaccination programme. The petitioners sought recognition of their injuries and access to compensation, arguing that the State had an obligation to provide relief to those harmed in the course of a government-mandated or government-promoted public health intervention.

India's COVID-19 vaccination programme was one of the most extensive administrative exercises in the country's post-independence history. The programme, conducted under the National Expert Group on Vaccine Administration for COVID-19 and later the COVID-19 Working Group of the National Technical Advisory Group on Immunisation, involved multiple approved vaccines including Covishield, Covaxin, and later Corbevax and others.

The Government of India consistently maintained the safety profile of the approved vaccines. However, as with all vaccines, a proportion of recipients experienced adverse events, ranging from mild reactions to rare but serious outcomes including thrombosis with thrombocytopenia syndrome, neurological complications, and in some cases, death.

The petitioners argued that the absence of a structured compensation mechanism left seriously injured individuals without a meaningful legal remedy, forcing them to pursue complex and expensive litigation as their only recourse.

The Supreme Court's Findings and Directions

The bench of Justices Vikram Nath and Sandeep Mehta, after hearing the matter, made two principal observations and issued corresponding directions.

First, the Court recorded that India does not appear to have in place any uniform or structured policy mechanism to provide redress to individuals who suffer adverse effects following vaccination. This finding was not a criticism of the vaccines themselves or of the vaccination programme, but a factual observation about the absence of an administrative compensation infrastructure for the small proportion of recipients who experience serious harm.

Second, the Court noted the importance of transparency in public health data. It directed that AEFI-related data be placed in the public domain on a periodic basis, so that the incidence of adverse events following immunisation is accessible to researchers, medical professionals, and the public.

On the basis of these findings, the Court directed the Ministry of Health and Family Welfare to formulate a no-fault compensation policy for serious AEFI cases arising from COVID-19 vaccines. The Court used the word "expeditiously," indicating that the government is expected to move with reasonable urgency in creating the framework.

The Court did not prescribe the specific structure or quantum of compensation, leaving those determinations to the government. It also did not assign liability to the Union Government for past adverse events, but established a constitutional and policy obligation to create a prospective mechanism.

India's Existing AEFI Monitoring System

India does have a system for monitoring and investigating adverse events following immunisation, but it is a public health surveillance mechanism rather than a compensation framework.

The National AEFI Committee, constituted under the Ministry of Health and Family Welfare, is responsible for causality assessment of serious and severe adverse events reported from the national immunisation programme. State AEFI Committees conduct preliminary assessments before referring cases to the national level. The process involves a clinical review of each reported case and a causality classification using the World Health Organisation's standard methodology.

The categories of causality under the WHO classification include "consistent causal association," "indeterminate," "inconsistent causal association," and "unclassifiable." A finding of consistent causal association means that the available evidence confirms a causal relationship between the vaccine and the adverse event.

However, a causality finding from the AEFI Committee does not by itself translate into compensation. There is no statutory entitlement to relief that flows from an AEFI causality assessment. The committee's findings are medical and epidemiological in nature, not legal determinations of liability.

It is this gap between the surveillance system and an actual compensation mechanism that the Supreme Court has directed the government to close.

The Global Context: How Other Countries Handle Vaccine Injury

The Supreme Court's direction places India in a policy conversation that most major vaccine-producing and vaccine-administering nations resolved decades ago.

The United States established its National Vaccine Injury Compensation Programme in 1986, creating a dedicated administrative tribunal, the Vaccine Court, through which claimants can seek compensation without suing vaccine manufacturers directly. The programme operates on a vaccine injury table that lists recognised adverse events and presumptive causation timeframes.

The United Kingdom's Vaccine Damage Payment Scheme provides a one-time payment to individuals who are severely disabled as a result of vaccination against specified diseases. The payment is structured as a statutory benefit rather than compensation for loss, and does not require proof of negligence.

Japan suspended the use of certain COVID-19 vaccines for a period following reports of adverse events, and operates a relief system under its Pharmaceuticals and Medical Devices Act that provides compensation for drug and vaccine injuries based on a causality assessment.

India's vaccination programme operated at a scale comparable to or exceeding all of these countries. The Supreme Court's direction to establish a no-fault framework brings India's policy framework into closer alignment with the approach taken by countries that have long recognised vaccine injury compensation as an element of a complete public health infrastructure.

What the Government Is Now Required to Do

The Union Government, specifically the Ministry of Health and Family Welfare, is now under a judicial direction to formulate a no-fault compensation policy for COVID-19 vaccine adverse events. The Court's use of the word "expeditiously" indicates that this is not a direction to be treated as open-ended.

The government will need to address several questions in designing the framework:

• Which vaccines and which adverse events will be covered

• What causality standard will be applied to determine eligibility

• What compensation amounts or categories will be available

• What administrative process claimants will follow to apply

• How the AEFI Committee's findings will interact with compensation decisions

• Whether the framework will cover only future adverse events or also address past cases

The matter remains pending before the Supreme Court, which is expected to monitor compliance with its direction and hear further submissions as the government's policy response takes shape.