State's Article 21 obligation necessitates a no-fault compensation framework for serious adverse events following COVID-19 immunization.

The proceedings originated from a Writ Petition under Article 32 filed by parents of young individuals who allegedly died due to complications (such as Cerebral Venous Sinus Thrombosis and Multisystem Inflammatory Syndrome) following COVID-19 vaccination.

Connected matters included appeals against an interim order of the Kerala High Court which had directed the Government to formulate a compensation policy for Adverse Events Following Immunization (AEFI).

Petitioners alleged that the Union Government failed to ensure informed consent, transparency in data, and adequate surveillance, thereby violating the right to life.

The Union of India maintained that vaccines underwent rigorous regulatory approval, an AEFI surveillance system was functional, and that aggrieved parties should pursue private remedies in consumer or civil courts rather than through writ jurisdiction.

Whether the absence of a uniform policy governing compensation in cases of death or injury following administration of COVID-19 vaccination results in a violation of the Right to Life protected under the Constitution?

Whether the Court can direct the respondents to frame a policy regarding no-fault compensation for AEFI?

The Court primarily applied Article 21 of the Constitution of India, interpreting the "Right to Health" as an integral facet of the "Right to Life".

It relied on State of Punjab v. Mohinder Singh Chawla, establishing the State's constitutional obligation to provide health facilities.

It relied on Union Carbide Corpn. v. Union of India, regarding the court’s duty to secure immediate relief for victims of tragedies.

The Court referred to Jacob Puliyel v. Union of India, which upheld the vaccine approval process but emphasized the State's duty to monitor and report AEFIs.

Furthermore, it invoked the principle of "No-Fault Liability," analogous to Section 164 of the Motor Vehicles Act, 1988, where relief is provided without the requirement of proving negligence.

The Court reasoned that while it would not interfere with scientific determinations of vaccine efficacy or causality—matters best left to domain experts—the State’s welfare obligations under Articles 21, 41, and 47 necessitate an equitable redressal mechanism for harms arising from national health interventions.

The Court observed that the existing AEFI monitoring system is functional, yet relying solely on tort-based litigation (civil or consumer courts) is inadequate for a mass immunization program because the burden of proving negligence is too high for grieving families.

By examining international precedents in Australia, the UK, and Japan, the Court determined that a "no-fault" framework is a standard feature of a welfare state.

Therefore, the Court concluded that the State cannot "shrug its responsibility" when rare but grave outcomes occur during a State-led public health drive.

It directed the Union of India, through the Ministry of Health and Family Welfare, to expeditiously formulate and place in the public domain a "no-fault compensation framework" for serious AEFI arising from COVID-19 vaccinations.

The Court declined to appoint an independent expert board, finding existing AEFI Committees sufficient.

The Court clarified that this framework does not constitute an admission of fault by the Union nor does it preclude victims from seeking other legal remedies.