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Supreme Court Orders No-Fault Vaccine Compensation Policy
In a significant judgment that underscores the welfare obligations of the modern state, the has directed the Union Government to frame a for individuals suffering serious adverse events following COVID-19 vaccination. A bench comprising Justice Vikram Nath and Justice Sandeep Mehta issued the directive on , in petitions alleging vaccine-linked deaths. The court emphasized that this mechanism would provide swift relief without the need to establish fault, while clarifying that it does not constitute an by the government. Existing systems for monitoring will continue, with relevant data to be periodically disclosed publicly, aligning with prior judicial observations.
This ruling addresses a critical gap in India's public health framework, particularly after the unprecedented COVID-19 vaccination drive that administered over 219.86 crore doses by . With 92,114 AEFI cases reported (0.0042% of doses), including 2,782 serious instances and 1,171 deaths, the decision balances public trust in immunization programs with support for rare but severe outcomes.
Genesis of the Petitions
The matter originated from Writ Petition (Civil) No. 1220/2021, , filed by parents Rachna Gangu and Venugopalan Govindan . They alleged that their daughters died in 2021 due to severe adverse effects after receiving the first dose of Covishield vaccine. The petitioners sought compensation, constitution of an independent expert committee to probe vaccine side effects, release of autopsy and investigation reports, and guidelines for early detection and treatment of AEFI.
Parallelly, the Union Government challenged a order dated , in Union of India v. Sayeeda K.A. & Ors (SLP(C) No. 16452/2023). The High Court, hearing a plea by Sayeeda K.A. (whose husband allegedly died post-vaccination), had directed the to frame guidelines for identifying vaccine-related deaths and compensating dependents within three months. The Centre argued that COVID-19 was declared a disaster under the , but not vaccine side effects, rendering such compensation inapplicable.
These cases were tagged together, with hearings culminating in extensive arguments on
. Justice Nath reserved orders, stating,
"We will decide if a committee is to be formed, what directions to be issued...we will examine everything in great detail."
The Court's Key Directions
The bench's operative orders were precise and multifaceted:
“Union of India to frame a for serious adverse events following COVID-19 vaccination.”
The court mandated the to develop this framework, ensuring compensation on a —meaning no proof of negligence required. Critically:
“The existing mechanism for monitoring adverse events following immunisation shall continue and relevant data may be periodically placed in the public domain.”
This echoes the 2021 judgment in the Dr. Jacob Puliyel case, reinforcing transparency. The bench rejected calls for a separate court-appointed expert body, observing:
“No separate court appointed expert body is considered necessary in view of the existing mechanisms for scientific assessment of adverse events following immunisation.”
Further safeguards included: “The formulation of the shall not be construed as or fault on the part of the Union of India or any other authority.” Affected persons remain free to pursue other legal remedies: “It is clarified that the judgment shall not preclude any person from pursuing remedy available in law.”
Judicial Rationale: Welfare State and No-Fault Liability
Authored by Justice Nath, the judgment framed no-fault schemes as a hallmark of welfare-state responses. It noted India's lack of a uniform redress mechanism for vaccination injuries, especially pressing given the scale of the COVID drive:
“India does not appear to have in place any uniform or structured policy mechanism to provide redress to individuals who suffer adverse effects following vaccination. This gap cannot be lightly overlooked, particularly when vaccination programmes are undertaken as public health measures under the aegis and authority of the State itself.”
The court rejected a purely fault-based lens:
“The relationship between the individual and the State cannot be viewed through the prism of fault-based liability.”
Acknowledging the program's life-saving impact, it confronted realities: “The State went above and beyond... 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.” The Constitution, per the bench, positions the state as an
"active guardian of welfare and dignity,"
invoking
's expansive right to health.
Centre's Counter-Arguments
The government resisted via a 2022 counter-affidavit, asserting vaccination was voluntary with informed consent on risks. Vaccines followed global protocols with structured AEFI monitoring; liability lay with third-party manufacturers, not the state. Compensation under Disaster Management was limited to COVID disease deaths, not side effects. The court, however, prioritized systemic relief over individual fault inquiries.
Legal Analysis: Precedents and Principles
This ruling evolves Indian jurisprudence on state accountability in mass public health interventions. diverges from traditional (e.g., under the or negligence suits), drawing from global models like the U.S. National Vaccine Injury Compensation Program (1986), which has compensated over $5 billion without litigation. In India, it aligns with precedents like (right to emergency medical care) and (living wills), expanding to preventive health duties.
Unlike fault-based claims requiring proof of causation (challenging in pharmaco-vigilance), no-fault streamlines via administrative panels, reducing court burden. It references the Puliyel case for data transparency, potentially enabling evidence-based claims. Critically, the non-admission clause shields the Centre from class-actions or admissions in future suits, while preserving civil remedies.
Broader Implications for Legal Practice
For legal professionals, this opens new frontiers:
- and Health Law : Reinforces PILs for policy gaps; expect surges in vaccine/drug injury petitions.
- Tort and Insurance : No-fault may inspire schemes for other mass programs (e.g., TB eradication), challenging adversarial litigation.
- Public Policy : Mandates inter-ministerial coordination (Health, Law, Finance); timelines implied for implementation.
- Litigation Strategy : Lawyers can dual-track: policy claims + courts. Causation battles persist, but data disclosure aids.
- Global Context : Positions India akin to 20+ nations with vaccine schemes, enhancing WHO compliance.
Impacts ripple to pharmaco-economics: manufacturers may seek indemnity clauses; public trust rises, aiding future drives.
Looking Ahead
The Supreme Court's directive fills a void exposed by the pandemic, affirming the state's dual role as vaccinator and protector. While implementation details—eligibility, quantum, verification—await policy framing, this precedent cements no-fault as a welfare tool. Legal practitioners must monitor notifications, advising clients on hybrid remedies. Ultimately, it humanizes public health law, ensuring
"certain categories of harm require swift relief without prolonged inquiry into fault."
