Rachana Gangu & Anrv.Union of India & Ors

Synopsis

This landmark judgment, delivered by the Supreme Court of India on March 10, 2026, addresses a constitutional challenge arising from deaths and injuries allegedly linked to COVID-19 vaccination. The petitioners, representing families who lost loved ones following vaccination, sought directions for compensation, independent inquiry, and formulation of protocols for adverse events following immunization (AEFI). The core legal issue was whether the absence of a uniform compensation policy for vaccine-related injuries or deaths violates the right to life under Article 21 of the Constitution. The Supreme Court, while declining to conduct individual scientific inquiries or constitute a parallel expert body, held that the State's constitutional obligation to protect health includes a duty to provide a structured redressal mechanism. It directed the Union of India to formulate a "no-fault compensation" framework for serious AEFI cases arising from COVID-19 vaccination, drawing upon international precedents and the positive obligations inherent in Article 21.

1. Basic Information of the Judgment

Case Title: Rachana Gangu & Anr. v. Union of India & Ors. (with connected matters)

Citation: 2026 INSC 218 (Reportable)

Court: Supreme Court of India

Jurisdiction: Civil Original Jurisdiction (Writ Petition under Article 32)

Case Numbers: Writ Petition (Civil) No. 1220 of 2021; with SLP(C) No. 16452/2023; T.P.(C) No. 1716/2023; T.P.(C) Nos. 2289-2294/2024

Coram: Justice Vikram Nath and Justice Sandeep Mehta

Nature of Bench: Division Bench

Date of Judgment: March 10, 2026

2. Legal Framework and Relevant Provisions

• Constitutional Provisions:
  Article 21: Right to life and personal liberty – includes right to health and bodily integrity.
  Article 14: Right to equality.
  Article 19(1)(a): Right to information.
  Article 41: Directive Principle – State to provide public assistance in cases of sickness and disablement.
  Article 47: Directive Principle – State's duty to raise the level of nutrition and improve public health.

• Statutory and Regulatory Framework (Contextual):
  Drugs and Cosmetics Act, 1940, and Rules thereunder – regulatory approval of vaccines.
  National AEFI Surveillance System – operational guidelines for monitoring adverse events.
  Indian Council of Medical Research (ICMR) and National Centre for Disease Control (NCDC) studies on vaccine safety.

• Key Precedents Relied Upon:
  Jacob Puliyel v. Union of India (2022) : Upheld regulatory approval process for COVID-19 vaccines; directed transparency in AEFI data.
  Parmanand Katara v. Union of India (1989) : Right to health is a facet of right to life.
  State of Punjab v. Mohinder Singh Chawla (1997) : Government has constitutional obligation to provide health facilities.
  State of Punjab v. Ram Lubhaya Bagga (1998) : State cannot say it has no obligation to provide medical facility.
  Distribution of Essential Supplies and Services During Pandemic, In re (2021) : Special duty on executive in times of emergency; policies must be proportionate.
  Bhopal Gas Tragedy-related jurisprudence (e.g., M.C. Mehta v. Union of India) : Duty to secure immediate relief to victims.

• International Materials Referred:
  WHO definition of AEFI (adverse event following immunization).
  No-fault compensation schemes in Australia (COVID-19 Vaccine Claims Scheme Policy 2021), United Kingdom, Japan, and the COVAX Facility.

3. Relevant Facts of the Case

• The lead petitioner, Rachana Gangu, lost both her daughters (aged 18 and 20) shortly after they received COVID-19 vaccination in May-June 2021. One died of Cerebral Venous Sinus Thrombosis (CVST), the other of Multisystem Inflammatory Syndrome (MIS-C/A).

• Several other petitions from the Kerala High Court were transferred to the Supreme Court, involving similar tragedies:
  Sayeeda K.A.: Husband died within hours of vaccination; post-mortem inconclusive but possibility of heart pathology noted.
  Renjith R.: Wife (31), pregnant with twins, died of Thrombocytopenia; cause classified as AEFI.
  Jean George: Daughter (19) died of intra-cranial bleeding.
  Rajagopalan K.: Petitioner suffered limbic encephalitis post-vaccination.
  Ginu G. Kumar: Wife (37) died of intra-cerebral haemorrhage with thrombosis with thrombocytopenia syndrome (TTS), a known complication of Covishield.
  Ansaria AK: Husband suffered paralysis post-vaccination; neurologist attributed it to vaccine.
  Narayanan MV: Daughter (18) died of Thrombotic Thrombocytopenia.

• The petitioners sought: (i) constitution of an independent expert medical board to inquire into deaths, (ii) formulation of protocols for early detection and treatment of AEFI, and (iii) grant of compensation.

• The Union of India opposed, arguing: (i) vaccines underwent rigorous regulatory approval, (ii) AEFI surveillance mechanism is adequate and transparent, (iii) TTS occurrence was extremely rare in India (0.001 per lakh doses), (iv) aggrieved persons can approach consumer courts for damages, and (v) no-fault compensation is not mandated by law.

4. Issues Before the Supreme Court

• Whether the absence of a uniform policy governing compensation in cases of death or injury following COVID-19 vaccination results in violation of the Right to Life protected under Article 21 of the Constitution?

• If yes, can this Court direct the respondents to frame a policy in that regard?

5. Ratio Decidendi of the Court

The Supreme Court disposed of the writ petitions and connected matters with the following key findings and directions:

• Right to Health Includes Post-Vaccination Redressal: The Court reaffirmed that Article 21 encompasses the right to health, which imposes a positive obligation on the State to act as provider, facilitator, and regulator. In the context of a mass public health intervention like a national vaccination program, this obligation extends to providing an accessible mechanism for redress where grave harm is alleged.

• Fault-Based Remedies are Inadequate: While civil suits and consumer complaints (based on negligence) are legally available, they are ill-suited for vaccine injury claims, which involve complex scientific causation questions, lengthy proceedings, and evidentiary burdens. Relegating affected families solely to such remedies violates the constitutional guarantee of a meaningful remedy.

• No-Fault Compensation Principle: The Court drew upon the principle of no-fault liability, already recognized in Indian law (e.g., Section 164 of the Motor Vehicles Act), and international examples (Australia, UK, Japan, COVAX) where no-fault vaccine injury compensation schemes exist. The rationale is that certain categories of harm require swift relief without prolonged inquiry into fault, especially when the harm occurs in the course of a State-led public health measure.

• State's Constitutional Duty Under Articles 41 and 47: The Directive Principles mandate the State to provide public assistance in cases of sickness and disablement (Article 41) and to improve public health (Article 47). The vaccination program was an expression of these commitments. The State cannot ignore its responsibility to those who suffered grave outcomes in the course of this program, even if the adverse events are rare.

• Causality Determination Left to Experts: The Court declined to conduct individual scientific inquiries or constitute a parallel expert body, holding that the existing AEFI Committees (National and State) are adequate for causality assessment. The Court's role is not to adjudicate scientific questions but to ensure the existence of a just and fair redressal framework.

• No Admission of Liability: The Court clarified that the direction to frame a no-fault compensation framework shall not be construed as an admission of liability or fault on the part of the Union of India or any authority. It is a welfare measure based on constitutional obligations.

6. Legal Framework Established / Clarified

This judgment breaks new ground by establishing/recognizing the following principles:

• Right to a Redressal Mechanism in Public Health Interventions: For the first time, the Court has explicitly held that the right to life under Article 21, in the context of a mass public health program undertaken by the State, includes the right to a structured, accessible, and equitable redressal mechanism for those who suffer serious adverse events. The absence of such a mechanism is a constitutional violation.

• No-Fault Compensation as a Constitutional Imperative: While no-fault compensation schemes exist in various statutes, this judgment elevates the principle to a constitutional expectation in the specific context of State-led health interventions. It recognizes that the relationship between the individual and the State in such contexts cannot be viewed solely through the prism of fault-based liability.

• Harmonizing Scientific Deference with Constitutional Vigilance: The Court demonstrated how to balance deference to scientific expertise and executive policy-making (by not interfering with vaccine approval or individual causality assessments) with its constitutional duty to protect fundamental rights (by mandating a compensation framework).

• Positive Obligation Under Article 21 Extended: The judgment extends the positive obligation doctrine under Article 21 from ensuring access to healthcare (as in previous cases) to ensuring a post-harm redressal mechanism. The State must not only provide the health intervention but also stand prepared to address its unintended consequences.

7. Court's Examination and Analysis

The Supreme Court's analysis was structured and nuanced:

• Acknowledgment of Suffering: The Court began by acknowledging the unprecedented grief and hardship caused by the pandemic and the specific tragedies narrated by the petitioners. This set a humane tone for the judgment.

• Deference to Scientific and Executive Domain: The Court explicitly stated that it would not adjudicate on vaccine efficacy, regulatory approval, or individual causality. It relied on its earlier decision in Jacob Puliyel which upheld the approval process. It also accepted that the existing AEFI surveillance mechanism, with expert committees, was adequate for scientific assessment.

• Identification of the Core Constitutional Gap: The Court identified that the real grievance was not about the scientific process but about the absence of any uniform remedy for those alleging grave harm. Families were left without a clear, accessible path to redress.

• Comparative Analysis of International Schemes: The Court surveyed no-fault compensation schemes in Australia, the UK, Japan, and the COVAX Facility. This comparative analysis demonstrated that such mechanisms are a recognized feature of welfare states in the context of mass vaccination.

• Application of Constitutional Principles:
  Article 21: The right to health includes a positive obligation to provide redress.
  Articles 41 and 47: The Directive Principles illuminate the State's welfare role and support the creation of such a framework.
  Principle of Non-Arbitrariness (Article 14): Leaving affected families to fend for themselves through lengthy, complex litigation, while the State provided vaccines to all, could be seen as arbitrary and unequal treatment.

• Rejection of the "Private Remedy" Argument: The Court held that relegating vaccine injury claims to consumer courts or civil suits is inadequate because of the difficulty in proving negligence/causation and the protracted nature of such proceedings. The State's constitutional duty goes beyond merely leaving the doors of courts open.

• Clarification on No-Fault Framework: The Court directed the Union to frame a "no-fault compensation framework" specifically for serious AEFI cases arising from COVID-19 vaccination. It did not prescribe the details, leaving it to the executive, but the direction itself is a significant judicial intervention.

8. Critical Analysis and Final Outcome

• Outcome: The Supreme Court disposed of the writ petitions and connected matters with the following directions:
  The Union of India (Ministry of Health and Family Welfare) shall expeditiously formulate and place in the public domain an appropriate no-fault compensation framework to address serious adverse events following immunisation (AEFI) arising in the context of COVID-19 vaccination.
  Existing AEFI monitoring mechanisms shall continue, and relevant data shall be placed in the public domain periodically as directed in Jacob Puliyel.
  No separate court-appointed expert body is necessary.
  The judgment does not preclude individuals from pursuing other legal remedies, and the compensation framework shall not be construed as an admission of liability.

• Critical Perspectives:
  Strengths: The judgment is a landmark in public health jurisprudence. It strikes a delicate balance between deference to scientific expertise and constitutional vigilance. By not interfering with vaccine approval or individual causality, it avoids overreach. By mandating a no-fault compensation framework, it fills a critical gap in the welfare state's response to a mass health intervention.
  Humane and Progressive: The judgment is deeply humane, recognizing the suffering of families and translating that recognition into a concrete, forward-looking direction. It draws upon global best practices to inform Indian constitutional law.
  Clarity on State's Role: It clarifies that the State's role in a public health emergency is not just to provide the intervention but also to stand by those who suffer unintended consequences. This strengthens the social contract.
  Potential Challenges: The implementation of the direction will be crucial. The scope of "serious adverse events," the quantum of compensation, the claims process, and the funding mechanism will need to be defined. The Court has left these details to the executive, which is appropriate, but the effectiveness of the judgment will depend on the policy framed.
  Precedent Value: This judgment will serve as a powerful precedent for future mass health interventions (e.g., future vaccination drives, public health campaigns). It establishes that the constitutional right to health includes a right to a redressal mechanism for harms arising from State-led health programs.
  No-Fault vs. Admission of Liability: The Court's careful clarification that the framework is not an admission of liability protects the State from a flood of claims based on fault, while still enabling a welfare-based compensation system.

• Core Final Directive: The constitutional guarantee of the right to life under Article 21, read with the Directive Principles, imposes a positive obligation on the State to provide an accessible and equitable redressal mechanism for serious adverse events arising from State-led public health interventions like mass vaccination. The absence of such a mechanism is a constitutional violation. The State must, therefore, formulate a no-fault compensation framework to address such harms, without waiting for individual fault-based litigation.

(MCQs)

1. In Rachana Gangu v. Union of India, the Supreme Court directed the Union of India to frame a compensation framework based on which principle?
A) Strict liability for vaccine manufacturers
B) No-fault compensation for serious adverse events following immunization
C) Ex gratia payment as a one-time measure
D) Compensation based on proof of negligence by the State

2. Which Article of the Constitution was primarily invoked by the Court to hold that the absence of a redressal mechanism violates fundamental rights?
A) Article 14 (Right to Equality)
B) Article 19(1)(a) (Right to Information)
C) Article 21 (Right to Life)
D) Article 32 (Right to Constitutional Remedies)

3. The Court declined to constitute an independent expert body to investigate individual deaths primarily because:?
A) It lacked the funds to do so.
B) The petitioners did not request it.
C) The existing National and State AEFI Committees were deemed adequate for scientific assessment.
D) The matter was sub judice in other courts.

4. Which of the following international examples of no-fault vaccine injury compensation was NOT cited by the Court?
A) Australia's COVID-19 Vaccine Claims Scheme
B) The United Kingdom's vaccine damage payment scheme
C) The United States' National Vaccine Injury Compensation Program (NVICP)
D) Japan's no-fault compensation scheme for temporary vaccinations