Rachana Gangu & Anr. Vs Union of India & Ors. (Supreme Court of India)
Conclusion: When a vaccination programme was undertaken as a State-led public health intervention, the government could not evade responsibility towards families who allege deaths or serious injuries following vaccination, particularly when official data itself acknowledged that some deaths occurred after COVID-19 vaccination. Observing that the Constitution did not view the right to life solely through the prism of fault, the Court said that Article 21 imposed a positive obligation on the State to ensure that affected families were not left without any accessible mechanism for redress.
Held: Several writ petitions were filed before the Supreme Court and the Kerala High Court by families of persons who allegedly died after receiving COVID-19 vaccination. Assessee sought constitution of an independent expert medical board to investigate such deaths, disclosure of AEFI data, and formulation of a policy providing compensation to families of persons who suffered death or serious injury following vaccination. The Kerala High Court had issued interim directions requiring the Union Government to frame a compensation policy. The Union of India challenged those directions before the Supreme Court and also sought transfer of connected petitions pending before the Kerala High Court. The issue arose for consideration was whether the absence of a uniform compensation framework for deaths or injuries allegedly caused by COVID-19 vaccination violated the right to life under Article 21; whether the Court could direct the Government to frame a compensation policy in respect of adverse events following immunisation. It was held that although the approval, safety and scientific evaluation of vaccines fall primarily within the domain of expert regulatory bodies, the right to health and dignity under Article 21 imposed a positive obligation on the State to ensure that individuals who allegedly suffer serious adverse consequences during a State-led vaccination programme were not left without an accessible mechanism of redress. The Court observed that insisting upon fault-based litigation in individual cases would impose an onerous burden on affected families and could lead to inconsistent outcomes. Recognizing international practice and the welfare obligations of the State, the Court held that a no-fault compensation mechanism would provide an equitable and expeditious avenue for relief. Accordingly, the Court directed the Union of India to formulate and publish a no-fault compensation policy for serious adverse events following COVID-19 vaccination. It was further held that the existing AEFI surveillance and investigation mechanisms were adequate, and therefore no independent court-appointed expert body was required. The Court also directed continued transparency in reporting AEFI data. Writ petitions and connected matters disposed of with directions to the Union Government to frame a no-fault compensation framework for vaccine-related adverse events, without affecting other legal remedies available to affected persons.
1. Leave granted in SLP (C) No. 16452/2023.
