New Delhi: The Supreme Court Tuesday ruled that a State’s “positive obligation” to safeguard the right to health necessitated an institutional mechanism for redressal of situations where citizens suffer adverse effects, even leading to deaths, following Covid-19 vaccination.
Hearing petitions by families who claimed they lost loved ones to rare post-vaccination complications, the court moved beyond the traditional “fault-based” liability model for awarding compensations.
Instead, the court determined that the Right to Life under Article 21 requires the government to support citizens who suffer grave, albeit rare, outcomes from national health interventions, and directing the Union to formulate a no-fault compensation framework for serious Adverse Events Following Immunisation (AEFI).
“The executive, which has been democratically elected by the people of the country and is accountable for its actions to them, is vested with the competence and authority to draft policies,” held the bench of Justices Vikram Nath and Sandeep Mehta.
“But at the same time, 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, as in this case,” the bench said.
In such circumstances, the constitutional duty of this court to safeguard the rights of citizens cannot be eclipsed, it said.
One of the petitions before the court was filed by the parents of two young girls who died within a month of receiving COVID-19 vaccination in 2021.
While no clear cause and effect link was established, the petition sought the constitution of an independent medical board of experts to inquire into such deaths, the formulation of protocols for early detection and treatment of AEFIs, and the grant of compensation.
Eight other petitions were filed by the spouses of pregnant women and the immediate family members of people who passed away within days of taking the vaccine with no history of any medical inconvenience.
Contentions in court
The core argument put up by the bereaved families highlighted the central government’s “failure to ensure transparency, informed consent and postvaccination surveillance, thereby constituting a violation of Article 21 of the Constitution”.
They alleged that deaths “caused after the administration of COVID 19 vaccines exposed structural defects in India’s vaccine governance regime”.
By March-April 2021, around 18 European countries had suspended or restricted the administration of AstraZeneca vaccine, of which Covishield is the Indian-manufactured version, limiting its usage to older age groups due to multiple vaccine-induced deaths, the families argued.
They also alleged that the government “despite having exclusive possession of facts essential for decision making, did not either publish causality assessments or maintain a publicly accessible portal”, which they said was a clear violation of the expectation recorded by this court in Jacob Puliyel v. Union of India.
They specifically contended that the Drugs Controller General of India publicly stated on 4 January 2021 that the vaccines were “110% safe”, which, according to the petitioners, “contributed to a false sense of absolute safety and undermined informed consent”.
On the other hand, the central government asserted that the COVID-19 vaccines underwent a rigorous and statutory regulatory approval process involving multiple layers of expert review by bodies such as the Central Drugs Standard Control Organisation (CDSCO), National Technical Advisory Group on Immunization (NTAGI) (NTAGI), and National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
The government maintained that a robust and transparent AEFI surveillance system is already operational, allowing for the reporting of adverse events via the CoWIN portal and conducting scientific causality assessments through specialised committees.
It argued that serious complications like Thromboembolic events (TTS, formation of dangerous blood clots in the body) are “extremely rare” in India, with a reporting rate of only 0.001 per lakh dosages, and claimed that the existing monitoring mechanism is adequate, while warning that an independent review would undermine public trust.
Furthermore on technical grounds, the government contended that compensation claims do not fall under writ jurisdiction because individuals have existing legal pathways, such as consumer courts, to pursue damages for negligence, particularly since Indian vaccine manufacturers do not have legal immunity.
Finally, the government said its own scientific assessments found no direct link between the vaccines and the deaths cited by petitioners, and insisted that any future framework for relief should not be viewed as an admission of fault or liability.
Science & fundamental rights
The court acknowledged that while it must exercise restraint in technical domains like vaccine approval, it cannot ignore the “deeper grievance” of families left without a uniform remedy.
The judgment emphasised that the State is not a “distant spectator to human suffering, but as an active guardian of welfare and dignity”.
Writing for the bench, Justice Vikram Nath noted, “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 (of) those affected families who have lost their near and dear ones.”
The absence of any structured framework to address serious adverse events raises constitutional concerns warranting an institutional response, the court added.
A central pillar of the court’s reasoning was the inadequacy of existing legal pathways, such as consumer courts or civil suits, which require proof of negligence.
The SC observed that vaccine injury claims involve complex scientific attribution that imposes an “onerous burden” on families. By insisting on a no-fault model, the court aimed to prevent a “multiplicity of individual proceedings” that risk inconsistent outcomes and unequal access to relief, thereby upholding the guarantee of equality under Article 14.
The principle of no-fault liability, the court noted, is already recognised in Indian law under the Motor Vehicles Act for cases where swift relief is required without prolonged inquiry into fault.
To justify the need for this mechanism, the Supreme Court pointed to international precedents where governments acknowledged the necessity of dedicated compensation mechanisms.
Countries like Australia (COVID-19 Vaccine Claims Scheme Policy 2021), the United Kingdom, and Japan have established structured frameworks covering medical expenses, loss of earnings, and funeral costs.
The court highlighted that even the WHO’s COVAX initiative provided lump-sum compensation for adverse events, emphasising that India’s lack of a uniform policy was a gap that “cannot be lightly overlooked”.
“In such a situation, 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,” wrote Justice Nath.
The absence of a coherent framework, therefore, calls for timely intervention, lest the rights of such persons remain only theoretical and without meaningful enforcement, the bench said.
Directives to Centre
While the court refused to appoint a new independent medical board to examine if that the existing National and State AEFI Committees are adequate, it issued strict directives for the future.
The central government, through the Ministry of Health and Family Welfare, must “expeditiously formulate and place in the public domain an appropriate no-fault compensation framework” specifically for serious AEFIs arising from COVID-19 vaccination, the court directed.
Furthermore, the court reiterated the need for transparency, ordering that surveillance data and reports of suspected adverse events be made publicly accessible on virtual platforms for scientific awareness and trust.
“No separate court-appointed expert body is considered necessary in view of the existing mechanisms for scientific assessment of adverse events following immunisation”, it noted.
The court concluded by clarifying that the formulation of this no-fault framework “shall not be construed as an admission of liability or fault on the part of the Union of India”. Instead, it is a welfare-state response aimed at providing an “expeditious and fair avenue of relief” for those who bore the weight of a collective societal necessity.
(Edited by Ajeet Tiwari)
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