State Cannot Evade Compensation Responsibility For Vaccine-Related Deaths During Mass Immunisation Programme, Article 21 Imposes Positive Obligation: Supreme Court
Kiran Raj
The Supreme Court of India Division Bench of Justice Vikram Nath and Justice Sandeep Mehta directed the Union of India to formulate a no-fault compensation framework for serious adverse events following COVID-19 vaccination, through the Ministry of Health and Family Welfare. The Court, hearing petitions from families who lost members shortly after receiving COVID-19 vaccines, held that Article 21 places a positive obligation on the State to ensure accessible redress mechanisms when grave harm arises from a State-led public health intervention, and that the absence of any structured compensation policy raises constitutional concerns warranting institutional response.
The petitions were filed by families of individuals who died or suffered serious injuries after receiving COVID-19 vaccines, seeking constitution of an independent expert medical board, protocols for early detection of adverse events following immunisation, and compensation. Similar petitions raising comparable grievances were subsequently filed before the Kerala High Court, which issued interim directions to the Ministry of Health and Family Welfare and the National Disaster Management Authority to formulate a policy for identifying adverse event cases and compensating affected families.
The petitioners contended that the vaccination programme, though officially described as voluntary, effectively operated under conditions of compulsion through travel restrictions and limited access to public services. They further alleged non-disclosure of known risks, inadequate post-vaccination surveillance, and violation of Articles 14, 19(1)(a), and 21 of the Constitution.
The Union of India maintained that vaccines underwent rigorous regulatory approval, that the existing adverse event surveillance mechanism was transparent and functional, and that aggrieved individuals could seek remedies before consumer courts or civil forums.
The Court clarified at the outset that it was not questioning vaccine efficacy, but was only examining whether there was a need for an institutional method to redress the grievances of citizens. It observed that the grievance before it was that families alleging serious harm in the course of a nationwide vaccination programme were left without any uniform mechanism for redress.
The Court recorded: "The Court therefore approaches the present proceedings with the limited objective of examining, whether in the exceptional context of a pandemic response, the absence of any structured framework to address serious adverse events raise constitutional concerns warranting an institutional response. In doing so, we reiterate that we are neither adjudicating upon the vaccine efficacy nor sitting in scientific review over the regulatory approval process. The question is confined to whether the State's welfare obligations require the exploration of an equitable mechanism of redressal for harm arisen in the course of a national public health intervention."
Stating that the right to health forms part of the right to life under Article 21, the Court observed: "Article 21 also embodies a positive obligation of the State to ensure that where grave harm is alleged to have occurred in the course of a State-led public health intervention, affected families are not left without any accessible mechanism of redress. The absence of such an institutional framework raises constitutional concerns which warrant a calibrated response."
The Court also noted that the vaccine approval process had been upheld in the earlier Jacob Puliyel decision and did not revisit that question.
On the nature of the vaccination drive as a State-led initiative, the Court stated: "The vaccination program undertaken during the pandemic was itself an expression of these constitutional commitments. The State went above and beyond in order to create a vaccination scheme and the same undoubtedly helped save many lives. But at the same time, as the government data itself suggests, it cannot be brushed aside that the same vaccines also led to loss of life. In such a situation, it is not appropriate that the State shrugs its responsibility in coming to aid to those affected families who have lost their near and dear ones."
The Court observed that "the Constitution does not conceive of the State as a distant spectator to human suffering, but as an active guardian of welfare and dignity." It referred to Article 41, which speaks of public assistance in cases of sickness and disablement, and Article 47, which declares the improvement of public health to be among the State's primary duties, as constitutional provisions illuminating the State's welfare obligations.
The Court further stated that "the relationship between the individual and the State cannot be viewed through the prism of fault-based liability," and that where the State undertakes an intervention of this scale, "the right to health under Article 21 would automatically extend to a corresponding obligation of institutional support in cases of grave outcomes, no matter how rare they are."
The Court observed that although it cannot undertake a scientific determination of causality in vaccine injury cases within writ jurisdiction, that limitation does not exhaust its constitutional inquiry. On the adequacy of existing remedies, it noted that remedies based solely on negligence, such as civil suits or consumer complaints, may be ill-suited in the context of mass immunisation programmes where scientific attribution of harm is often complex. Requiring affected families to prove fault in each case would impose an onerous burden and could lead to inconsistent outcomes, the Court stated.
The Court recorded that "the State cannot be heard to say that those who experience serious adverse consequences must fend for themselves, without any clear or accessible avenue of relief."
On the question of separation of powers, the Court stated that "this constitutionally protected separation of powers cannot in any scenario come in the way of Judiciary when the fundamental rights of its citizens are violated due to executive policies, or by lack of them."
On the no-fault compensation framework, the Court referred to similar mechanisms adopted in the United Kingdom, Australia, and Japan, where dedicated programmes provide financial assistance to individuals suffering adverse effects following vaccination, enabling swift relief without requiring lengthy litigation. It further stated that the responsibility of the State in monitoring adverse events "cannot end at surveillance alone, but must extend to providing fair compensation to those who suffered vaccine-related injury."
The Court directed: "The Union of India shall, through the Ministry of Health and Family Welfare, frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination."
"The existing mechanisms for monitoring adverse events following immunisation shall continue, and relevant data shall be periodically placed in the public domain in accordance with the observations in Jacob Puliyel."
"No separate court-appointed expert body is considered necessary in view of the existing mechanisms for scientific assessment of adverse events following immunisation."
"It is clarified that this judgment shall not preclude any person from pursuing such other remedies as may be available in law. Equally, the formulation of the no-fault framework shall not be construed as an admission of liability or fault on the part of the Union of India or any authority."
Case Title: Rachana Gangu & Anr. v. Union of India & Ors.
Neutral Citation: 2026 INSC 218
Case Number: Writ Petition (Civil) No. 1220 of 2021 with connected matters
Bench: Justice Vikram Nath and Justice Sandeep Mehta
