Summary
Families of persons who died or were injured after COVID-19 vaccination sought an inquiry, AEFI protocols and compensation. Without deciding causation or questioning vaccine approval, the Court held that Article 21 places a positive duty on the State: those suffering serious adverse events in a State-led mass immunisation programme should not be left only to fault-based remedies. It directed the Union to frame a no-fault compensation policy and declined to constitute an independent expert body.
Issues
- Whether the absence of a uniform policy for compensation in cases of death or injury following COVID-19 vaccination violates the right to life under Article 21.
- If so, whether the Court can direct the Union to frame such a policy.
- Whether an independent expert medical board should be constituted to examine the deaths.
Provisions considered
- Article 21, Constitution of IndiaThe right to health is part of the right to life and carries a positive State obligation. Where grave harm is alleged from a State-led public health intervention, affected families must have an accessible means of redress, regardless of fault. (¶¶ 14, 16, 20, 25, 27, 31, 34)
- Article 14, Constitution of IndiaLeaving vaccine-injury claims to many separate negligence proceedings risks inconsistent outcomes and unequal access to relief, undermining equality. (¶ 26)
- Articles 41 and 47, Constitution of IndiaDirective Principles on public assistance in sickness and disablement and on improving public health show that the State should actively protect welfare; the vaccination programme was itself an expression of these commitments. (¶¶ 24, 25)
- Section 164, Motor Vehicles Act, 1988Cited as an example that no-fault liability is known to Indian law, resting on the idea that some harms need quick relief without a lengthy inquiry into fault. (¶ 28)
- Article 32, Constitution of IndiaThe Court will not decide scientific causation in individual cases or set up a parallel expert body in writ jurisdiction. It may still require the executive to fill a policy gap that affects fundamental rights. (¶¶ 23, 33, 36)
Held
- The Court was not deciding vaccine efficacy or reviewing the regulatory approval process, which Jacob Puliyel had already found lawful, nor was it determining causation between vaccination and individual deaths, a matter for domain experts. An adverse event following immunisation does not necessarily imply a causal link. (¶¶ 17, 19, 21, 22, 23)
- Article 21 does not view the right to life only through the lens of fault. Where the State undertakes a mass public health intervention, the right to health carries a corresponding duty of institutional support for grave outcomes, however rare, and affected families must not be left without accessible redress. (¶¶ 20, 25, 27)
- Civil and consumer remedies remain available but are ill-suited as the only route to redress in a mass immunisation programme: proving negligence is an onerous burden on affected families, and many separate proceedings risk inconsistent outcomes and unequal relief, contrary to Article 14. (¶ 26)
- No-fault liability is known to Indian law, as in Section 164 of the Motor Vehicles Act, and several jurisdictions run no-fault vaccine-injury compensation schemes. India has no uniform or structured mechanism for those who suffer serious adverse effects after vaccination, and this gap calls for intervention. (¶¶ 28, 29, 30, 31)
- Policy design belongs to the executive, but separation of powers does not prevent the Court from acting when the absence of a policy affects fundamental rights. The State's responsibility, recognised in Jacob Puliyel for monitoring adverse events, extends to fair compensation for vaccine-related injury. (¶¶ 32, 33, 34)
- The existing National and State AEFI Committees are an adequate mechanism to investigate deaths and injuries. With no material showing that they do not function, the Court declined to constitute a separate expert body or order independent inquiries into individual deaths. (¶¶ 36, 38)
Result
Writ petition and connected matters disposed of with directions. The Union, through the Ministry of Health and Family Welfare, is to frame and publish a no-fault compensation policy for serious adverse events following COVID-19 vaccination. AEFI monitoring is to continue, with data periodically placed in the public domain. No court-appointed expert body is needed. Other legal remedies remain open, and framing the policy is not an admission of liability by the Union.