In a significant ruling concerning public health accountability, the Supreme Court on March 10 directed the Union Government to formulate a no-fault compensation policy for individuals who suffered serious adverse events following COVID-19 vaccination.
The Court held that while vaccination during the pandemic was undertaken to protect public health, families claiming severe harm after vaccination should not be left without an accessible framework to seek redress.
A bench of Justices Vikram Nath and Sandeep Mehta delivered the judgment while deciding a batch of petitions led by Rachana Gangu & Anr. v. Union of India & Ors..
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Background of the Case
The lead petition was filed under Article 32 of the Constitution by parents who alleged that their daughters died after receiving COVID-19 vaccines. They sought directions for:
- Creation of an independent expert medical board to investigate such deaths
- Transparent reporting of adverse events following immunization (AEFI)
- Compensation to families of individuals who allegedly died after vaccination.
Similar petitions were also pending before the Kerala High Court. In one such case, the High Court had directed authorities to formulate a policy to identify AEFI cases and compensate affected families.
The Union Government challenged that interim direction before the Supreme Court, which eventually heard all related petitions together.
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Petitioners’ Arguments
Counsel for the petitioners argued that the vaccination programme suffered from lack of transparency and inadequate communication about possible side effects.
They contended that although vaccination was officially voluntary, restrictions on unvaccinated individuals created pressure on citizens to take the vaccine.
The petitioners also claimed that scientific studies had linked certain vaccines to rare blood-clotting disorders, and that the government allegedly failed to disclose complete information about adverse events.
According to them, the absence of a clear compensation mechanism for families of those who allegedly died after vaccination violated Articles 14, 19(1)(a) and 21 of the Constitution.
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Centre’s Response
The Union Government opposed the petitions and defended the vaccination programme.
It submitted that COVID-19 vaccines were approved through a rigorous regulatory process involving expert bodies such as:
- Central Drugs Standard Control Organisation (CDSCO)
- National Technical Advisory Group on Immunization (NTAGI)
- National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
The government also stated that India already has a well-established AEFI surveillance system, where serious adverse events are investigated by state and national committees of medical experts.
It further argued that individuals seeking compensation could pursue remedies through civil courts or consumer forums if negligence was involved.
Court’s Observations
The Supreme Court noted that the right to health forms an integral part of the right to life under Article 21 of the Constitution.
The bench clarified that it was not examining the scientific validity of vaccines or the regulatory approval process, which had already been upheld in earlier judgments.
However, the Court emphasised that when the State undertakes a massive public health intervention like a nationwide vaccination programme, it must also consider mechanisms to assist individuals who suffer rare but serious adverse outcomes.
“The Constitution does not conceive of the State as a distant spectator to human suffering, but as an active guardian of welfare and dignity,” the bench observed.
The Court also pointed out that forcing affected families to prove negligence in each case through lengthy litigation may impose an unreasonable burden.
Need for a No-Fault Compensation Mechanism
Referring to international practices, the Court observed that many countries operate no-fault vaccine injury compensation schemes to provide swift financial assistance without requiring proof of negligence.
Such systems, the bench noted, are meant to ensure fair and prompt relief for individuals who suffer rare vaccine-related injuries.
The Court found that India currently lacks a uniform policy framework addressing such claims in the context of COVID-19 vaccination.
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Court’s Decision
The Supreme Court disposed of the petitions with the following directions:
- The Union Government must frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination.
- Existing mechanisms for monitoring adverse events following immunisation (AEFI) will continue.
- The government must ensure transparent public disclosure of AEFI data.
- The Court declined to establish a separate expert body, holding that the current national and state AEFI committees are adequate.
- The judgment does not prevent individuals from pursuing other legal remedies available under law.
With these directions, the Supreme Court disposed of the writ petition and all connected matters.
Case Title: Rachana Gangu & Anr. v. Union of India & Ors.
Case No.: Writ Petition (Civil) No. 1220 of 2021 with connected matters
Decision Date: 10 March 2026
