A) ABSTRACT / HEADNOTE
The decision in Rachana Gangu v. Union of India marked a significant constitutional development concerning vaccine injury compensation and the State’s welfare obligations during public health emergencies. The Supreme Court examined whether the absence of a structured compensation mechanism for persons allegedly suffering serious adverse effects after COVID-19 vaccination violated the guarantee of life and dignity under Article 21 of the Constitution of India. The Court declined to interfere with the scientific framework governing vaccine approval and adverse event monitoring. It accepted the validity of the existing vaccination regime and reiterated the findings earlier recorded in Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533. However, the Court simultaneously acknowledged that the absence of a uniform institutional redress mechanism left affected families without accessible relief.
The judgment expanded the constitutional understanding of the right to health. The Court held that a welfare State cannot remain indifferent when grave injuries allegedly occur during a State-led immunisation programme. It recognised that ordinary civil remedies based on negligence were inadequate in the context of mass vaccination programmes involving complex scientific causation. Drawing support from comparative constitutional practices and international vaccine compensation schemes, the Court directed the Union Government to formulate a no-fault compensation framework for serious adverse events following COVID-19 vaccination. The ruling balanced judicial restraint in scientific matters with constitutional accountability in protecting dignity, equality, and welfare. The judgment therefore strengthened India’s constitutional jurisprudence on public health governance, State responsibility, and social justice during emergencies.
Keywords:
COVID-19 Vaccination, Article 21, Right to Health, No-Fault Compensation, Vaccine Injury, Adverse Event Following Immunization (AEFI), Public Health Law, Constitutional Governance
B) CASE DETAILS
i) Judgment Cause Title
Rachana Gangu & Anr. v. Union of India & Ors.
ii) Case Number
Writ Petition (Civil) No. 1220 of 2021
With Civil Appeal arising out of SLP(C) No. 16452 of 2023
And Transfer Petition (Civil) No. 1716 of 2023
And Transfer Petition (Civil) Nos. 2289-2294 of 2024
iii) Judgment Date
10 March 2026
iv) Court
Supreme Court of India
v) Quorum
Justice Vikram Nath
Justice Sandeep Mehta
vi) Author
Justice Vikram Nath
vii) Citation
2026 INSC 218
viii) Legal Provisions Involved
Article 14 of the Constitution of India
Article 19(1)(a) of the Constitution of India
Article 21 of the Constitution of India
Article 32 of the Constitution of India
Article 41 of the Constitution of India
Article 47 of the Constitution of India
Section 164 of the Motor Vehicles Act, 1988
Drugs and Cosmetics Act, 1940
ix) Judgments Overruled by the Case
None
x) Law Subjects Involved
Constitutional Law
Public Health Law
Administrative Law
Human Rights Law
Medical Law
Tort Law
Welfare Jurisprudence
C) INTRODUCTION AND BACKGROUND OF JUDGEMENT
The litigation emerged from the devastating consequences of the COVID-19 pandemic and the nationwide vaccination programme implemented by the Union Government. Several petitioners approached constitutional courts alleging that family members suffered fatal or severe medical complications shortly after receiving COVID-19 vaccines. The petitions did not merely challenge individual medical events. They questioned the broader constitutional adequacy of India’s vaccine governance structure. The petitioners argued that despite extensive governmental control over vaccination, there existed no meaningful compensation mechanism for families alleging vaccine-related injuries or deaths. The Court treated these concerns as involving the intersection of public health policy, constitutional welfare obligations, and human dignity.
The Court noted that the petitions arose in extraordinary historical circumstances. The nationwide vaccination programme constituted one of the largest public health exercises in India’s history. Millions of citizens received vaccines under an urgent emergency response framework. During this process, concerns surfaced globally regarding rare but severe side effects associated with certain vaccines, particularly thrombosis and thrombocytopenia syndromes linked with AstraZeneca vaccines and their local variants. The petitioners contended that the State failed to adequately disclose risks, ensure transparency, and establish mechanisms for timely relief. The litigation therefore transcended private disputes and evolved into a constitutional examination of whether the State’s obligations under Article 21 required institutional support for persons allegedly injured during a State-sponsored immunisation drive.
The Court carefully distinguished between scientific review and constitutional review. It clarified that it would not reassess vaccine efficacy or interfere with expert regulatory approvals. Instead, the constitutional inquiry focused upon whether the State could constitutionally leave affected families without accessible redressal mechanisms. The judgment reflected a delicate judicial balance. It preserved deference toward scientific expertise while simultaneously recognising constitutional duties arising from public health interventions. This dual approach became the central foundation of the Court’s reasoning.
D) FACTS OF THE CASE
The lead petition involved the tragic deaths of two daughters of the petitioners after receiving COVID-19 vaccinations. One daughter reportedly developed Cerebral Venous Sinus Thrombosis (CVST) after vaccination and later died. The second daughter allegedly developed Multisystem Inflammatory Syndrome and also died following inoculation. Similar petitions from Kerala involved deaths and severe injuries allegedly linked to vaccination. These included cases involving thrombocytopenia, intracranial bleeding, paralysis, autoimmune encephalitis, and thrombotic disorders following administration of Covishield vaccines.
The Kerala High Court, while considering one such petition in Sayeeda K.A. v. Union of India, directed authorities to formulate a policy for identifying AEFI cases and compensating families of deceased persons. The Union Government challenged this interim order before the Supreme Court through special leave proceedings. Simultaneously, several transfer petitions were filed to consolidate similar matters pending before the Kerala High Court. Consequently, the Supreme Court treated the writ petition under Article 32 as the lead matter for resolving all connected disputes.
The petitioners alleged violations of Articles 14, 19(1)(a), and 21. They argued that the vaccination campaign was not genuinely voluntary because governmental restrictions pressured citizens into vaccination. They further alleged suppression of adverse event data, inadequate disclosure of risks, and failure to maintain transparency regarding causality assessments. Particular emphasis was placed on international reports linking AstraZeneca vaccines with rare clotting disorders. The petitioners claimed that despite awareness of these risks, the State continued promoting vaccines without adequate warning mechanisms.
The Union Government defended the vaccination regime by emphasising the robust statutory approval framework under the Drugs and Cosmetics Act, 1940. It highlighted the involvement of expert bodies including the CDSCO, NTAGI, and NEGVAC. The Government further argued that India already possessed a comprehensive AEFI monitoring structure involving scientific experts. It contended that vaccine-related injuries required scientific causation assessments unsuitable for writ jurisdiction. According to the Government, affected persons could pursue ordinary remedies before consumer courts or civil forums.
E) LEGAL ISSUES RAISED
i. Whether absence of a uniform compensation policy for vaccine-related deaths and injuries violated Article 21 of the Constitution?
ii. Whether the Supreme Court could direct the Union Government to formulate a no-fault compensation framework?
iii. Whether existing AEFI monitoring mechanisms were constitutionally adequate?
iv. Whether constitutional courts should interfere in scientific and regulatory vaccine determinations?
F) PETITIONER / APPELLANT’S ARGUMENTS
The petitioners argued that the State violated constitutional guarantees by conducting a nationwide vaccination programme without ensuring adequate safeguards for affected citizens. They contended that vaccination was effectively compulsory because restrictions on travel and access to services pressured citizens into inoculation. Therefore, the State assumed a corresponding obligation to compensate persons suffering grave consequences. The petitioners invoked Article 21 and argued that bodily autonomy and informed consent were undermined through misleading assurances regarding vaccine safety. They specifically criticised public statements declaring vaccines “110% safe.”
The petitioners further argued that the Government failed to maintain transparency concerning adverse event data. They relied heavily upon international developments where several European nations restricted AstraZeneca vaccines after reports of thrombosis and thrombocytopenia syndromes. According to them, Indian authorities withheld crucial information necessary for informed decision-making. They alleged that the Government failed to establish publicly accessible causality assessment databases despite directions issued in Jacob Puliyel v. Union of India. This alleged opacity violated Article 19(1)(a), which includes the right to receive information.
The petitioners also contended that ordinary negligence-based litigation could not provide effective remedies in vaccine injury cases. Scientific causation is inherently difficult to establish. Most affected families lacked financial or technical resources to engage in prolonged litigation. Therefore, constitutional courts had a duty to ensure accessible and equitable relief. They relied upon welfare principles embedded in Articles 41 and 47 and argued that public health programmes impose reciprocal obligations upon the State. The petitioners ultimately sought an independent expert committee and a comprehensive compensation framework.
G) RESPONDENT’S ARGUMENTS
The Union Government strongly defended the vaccination programme and argued that all approvals complied with statutory and scientific procedures. It relied extensively upon Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533, where the Supreme Court had already upheld the legality of vaccine approvals. The respondents argued that expert bodies including CDSCO, NTAGI, and NEGVAC scrutinised all scientific data before granting approvals. Therefore, the Court should avoid substituting judicial opinion for scientific expertise.
The respondents further submitted that India possessed a well-established AEFI surveillance system functioning for over a decade. They explained that serious adverse events were investigated by State and National AEFI Committees comprising medical experts. Additional specialists including neurologists and cardiologists were included due to the pandemic’s unique nature. The Government also emphasised that causality assessment reports were publicly available on the Ministry of Health website. Posters and advisories explaining risks and benefits were displayed at vaccination centres nationwide.
The Government additionally argued that thrombosis-related adverse events remained extremely rare in India. Statistical evidence indicated that TTS occurrences constituted only 0.001 cases per lakh doses administered. According to the respondents, allowing independent judicially supervised inquiries would undermine public confidence in vaccination systems and damage public health interests. Finally, the Government contended that compensation claims belonged within ordinary civil or consumer law mechanisms rather than writ jurisdiction. Manufacturers enjoyed no immunity in India. Therefore, affected individuals could pursue negligence claims before appropriate forums.
H) RELATED LEGAL PROVISIONS
i. Article 21 of the Constitution of India
The Court treated Article 21 as encompassing the right to health, dignity, bodily integrity, and access to institutional welfare protections. Reliance was placed upon Parmanand Katara v. Union of India, (1995) 3 SCC 248, State of Punjab v. Mohinder Singh Chawla, (1997) 2 SCC 83, and State of Punjab v. Ram Lubhaya Bagga, (1998) 4 SCC 117. These decisions established that healthcare obligations form part of constitutional governance.
ii. Article 14 of the Constitution
The Court observed that forcing families into fragmented negligence litigation could create inconsistent outcomes and unequal access to remedies. Absence of structured relief therefore implicated equality concerns.
iii. Article 41 and Article 47
The judgment significantly relied upon Directive Principles of State Policy. Article 41 contemplates public assistance during sickness and disablement. Article 47 imposes duties concerning public health improvement. The Court used these provisions to strengthen welfare-based constitutional interpretation.
iv. Section 164 of the Motor Vehicles Act, 1988
The Court drew analogy from statutory no-fault liability principles. Section 164 imposes compensation obligations irrespective of fault. The Court used this framework to justify vaccine compensation schemes.
I) PRECEDENTS ANALYSED BY COURT IN THIS CASE
i. Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533
The Court reaffirmed that vaccine approvals complied with statutory procedures. The judgment also recognised existing AEFI surveillance systems and emphasised transparency regarding adverse event data. The present case relied heavily upon Jacob Puliyel to avoid reopening scientific disputes.
ii. Union Carbide Corporation v. Union of India, (1989) 3 SCC 38
The Court referred to the Bhopal Gas Tragedy judgment to highlight constitutional compassion and institutional responsibility toward victims of mass harm. The precedent reinforced the judiciary’s humanitarian role during catastrophic events.
iii. Distribution of Essential Supplies and Services During Pandemic, In re, 2021 SCC OnLine SC 372
The Court cited this case to reaffirm that executive actions during emergencies remain subject to constitutional scrutiny. Public health emergencies cannot justify arbitrary governance.
iv. Gujarat Mazdoor Sabha v. State of Gujarat, AIR 2020 SC 4601
This precedent established that pandemic-related policies must satisfy proportionality standards. The Court used it to balance executive discretion with constitutional accountability.
v. Gaurav Kumar Bansal v. Union of India, W.P.(C) No. 539/2021
The Court relied upon this decision concerning ex-gratia compensation for COVID-19 deaths. It demonstrated that constitutional courts may direct policy formulation where absence of relief mechanisms threatens dignity and welfare.
J) JUDGEMENT
a. RATIO DECIDENDI
The Supreme Court held that although scientific causation assessments fall within executive and expert domains, the Constitution imposes positive welfare obligations upon the State where harm allegedly arises during a State-led public health intervention. The Court recognised that absence of any structured compensation mechanism for serious vaccine-related injuries violated constitutional expectations under Article 21. It therefore directed the Union Government to formulate a no-fault compensation framework for serious adverse events following COVID-19 vaccination.
The Court clarified that no-fault compensation does not amount to admission of negligence. Instead, it reflects constitutional solidarity and welfare obligations in exceptional circumstances. The judgment balanced judicial restraint regarding scientific matters with constitutional intervention concerning institutional welfare mechanisms.
b. OBITER DICTA
The Court observed that constitutional governance requires transparency in public health administration. It reiterated earlier directions requiring accessible reporting mechanisms for adverse events and public dissemination of causality assessments. The Court also acknowledged comparative international practices recognising vaccine injury compensation schemes.
c. GUIDELINES
i. The Union Government shall frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination.
ii. Existing AEFI monitoring mechanisms shall continue functioning.
iii. Relevant adverse event data shall be periodically placed in the public domain.
iv. No separate court-appointed expert body is required.
v. Aggrieved persons remain free to pursue alternative legal remedies.
K) CONCLUSION & COMMENTS
The judgment represents a transformative development in Indian public health constitutionalism. The Court consciously avoided entering scientific controversies concerning vaccine efficacy. Yet it simultaneously refused to permit constitutional invisibility of affected families. The recognition that welfare obligations survive even absent proof of fault constitutes the most important contribution of this decision. The Court effectively constitutionalised the concept of no-fault vaccine compensation within India’s welfare jurisprudence.
The ruling also demonstrates the gradual evolution of Article 21 from a negative liberty guarantee into a framework imposing affirmative duties upon the State. Earlier health rights cases primarily focused upon access to treatment and emergency care. This judgment extends constitutional protection into the domain of institutional compensation for harms arising during public welfare programmes. The reasoning aligns Indian jurisprudence with comparative international practices while retaining constitutional specificity grounded in Directive Principles.
Another important dimension concerns separation of powers. The Court exercised calibrated restraint by refusing independent scientific inquiries or judicial substitution of medical expertise. Simultaneously, it affirmed that constitutional courts may intervene where absence of policy frameworks undermines dignity and equality. This balance strengthens democratic accountability without judicial overreach.
The judgment may influence future litigation involving mass public health programmes, pharmaceutical regulation, disaster compensation, and welfare obligations during emergencies. It reinforces the constitutional principle that citizens participating in collective public welfare initiatives cannot be abandoned when grave harm allegedly results. The decision therefore deepens the constitutional relationship between public health governance and human dignity in India.
L) REFERENCES
a. Important Cases Referred
- Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533
- Union Carbide Corporation v. Union of India, (1989) 3 SCC 38
- Parmanand Katara v. Union of India, (1995) 3 SCC 248
- State of Punjab v. Mohinder Singh Chawla, (1997) 2 SCC 83
- State of Punjab v. Ram Lubhaya Bagga, (1998) 4 SCC 117
- Distribution of Essential Supplies and Services During Pandemic, In re, 2021 SCC OnLine SC 372
- Gujarat Mazdoor Sabha v. State of Gujarat, AIR 2020 SC 4601
- Gaurav Kumar Bansal v. Union of India, W.P.(C) No. 539/2021
b. Important Statutes Referred
- Constitution of India
- Drugs and Cosmetics Act, 1940
- Motor Vehicles Act, 1988
- World Health Organization Guidelines on Adverse Events Following Immunization.
