The Supreme Court has directed the Union Government to formulate and publish a no-fault compensation policy for individuals who suffered serious adverse events following COVID-19 vaccination, holding that the absence of such a framework raises constitutional concerns under the right to life and health guaranteed by Article 21 of the Constitution.
The Court emphasized that while vaccination programs were undertaken in extraordinary circumstances to protect public health, families alleging grave harm cannot be left without an accessible institutional mechanism for redress.
Case Details
- Case Title: Rachana Gangu & Anr. v. Union of India & Ors.
- Court: Supreme Court of India
- Bench: Justice Vikram Nath and Justice Sandeep Mehta
- Date of Judgment: 10 March 2026
- Citation: 2026 INSC 218
- Case Type: Writ Petition (Civil) No. 1220 of 2021 with connected matters
Background of the Petitions
The proceedings originated from petitions filed by families who alleged that their relatives died or suffered severe medical complications after receiving COVID-19 vaccines. The lead petition was filed by parents whose two daughters died after receiving their first vaccine doses.
One daughter developed Cerebral Venous Sinus Thrombosis (CVST) and passed away on 19 June 2021, while the other died on 10 July 2021 after developing Multisystem Inflammatory Syndrome.
Several other petitions from the Kerala High Court were also transferred to the Supreme Court as they raised similar issues relating to compensation for alleged vaccine-related injuries or deaths. These included cases involving intracranial bleeding, thrombocytopenia, autoimmune encephalitis, thrombosis with thrombocytopenia syndrome, and paralysis allegedly following vaccination.
One petition concerned a pregnant woman who died after receiving the vaccine; another involved a young woman who died from intracranial bleeding shortly after vaccination despite having no prior neurological illness. In another case, the petitioner’s husband developed paralysis after vaccination, with a neurologist’s report attributing the condition to the Covishield vaccine.
These cases were heard together to examine whether India lacked a structured compensation system for serious adverse events following immunization (AEFI).
Petitioners’ Arguments
The petitioners argued that the government failed to ensure transparency, informed consent, and effective post-vaccination surveillance, thereby violating fundamental rights under Articles 14, 19(1)(a), and 21 of the Constitution.
They contended that vaccination, though officially voluntary, was effectively compulsory because unvaccinated individuals faced restrictions on travel and access to public spaces and services. According to them, this created pressure on citizens to take vaccines without adequate disclosure of potential risks.
The petitioners further pointed out that international concerns had emerged regarding the AstraZeneca vaccine, of which Covishield is a version, linking it to vaccine-induced thrombotic thrombocytopenia (VITT). They argued that several countries restricted its use, while India allegedly failed to disclose complete adverse-event data.
Another key allegation was that the Drug Controller General of India had publicly stated that the vaccines were “110% safe,” which petitioners claimed created a false sense of absolute safety and undermined informed consent.
The petitioners ultimately sought the constitution of an independent expert medical board, transparent publication of AEFI data, and a compensation scheme for affected families.
Union Government’s Defence
The Union of India strongly opposed the petitions and maintained that the COVID-19 vaccines were approved through a rigorous statutory regulatory process involving multiple expert bodies, including the Central Drugs Standard Control Organisation (CDSCO), the National Technical Advisory Group on Immunization (NTAGI), and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
The government argued that the AEFI monitoring system in India is administered by expert committees at the state and national levels and allows reporting by individuals, doctors, and health officials through mechanisms such as the CoWIN portal.
It also submitted that thromboembolic events linked to vaccines were extremely rare, stating that the reporting rate in India was 0.001 per one lakh doses, making such events statistically negligible.
Further, the government contended that compensation claims for alleged vaccine injuries could be pursued through civil courts or consumer forums under negligence law. It emphasized that vaccine manufacturers in India do not enjoy legal immunity from such claims.
Issues Before the Supreme Court
The Court framed two primary questions for determination:
- Whether the absence of a uniform policy for compensation in cases of death or injury following COVID-19 vaccination violates the constitutional right to life.
- Whether the Court can direct the government to formulate such a policy.
Right to Health Under Article 21
The Court reiterated that the right to life under Article 21 includes the right to health and bodily integrity. It noted that constitutional jurisprudence has long recognized the State’s duty to safeguard public health and ensure access to healthcare.
Referring to earlier precedents, the Court observed:
“It is now settled law that right to health is integral to the right to life. Government has a constitutional obligation to provide health facilities.”
The Court emphasized that constitutional courts must exercise restraint in scientific and policy matters, but they cannot ignore situations where individuals suffer grave harm during State-led public health programs.
Court Clarifies It Is Not Reviewing Vaccine Safety
The Supreme Court clarified that the case was not about the scientific validity or safety of vaccines. It referred to its earlier decision in Jacob Puliyel v. Union of India, which upheld the regulatory approval process for COVID-19 vaccines.
The Court quoted from that judgment:
“We do not agree with the submission on behalf of the petitioner that emergency approvals to the vaccines were given in haste, without properly reviewing the data from clinical trials.”
It also noted that studies conducted by the Indian Council of Medical Research (ICMR) and the National Centre for Disease Control concluded that there was no direct link between vaccines and sudden deaths, and that vaccines were generally safe with extremely rare side effects.
Constitutional Duty of the State
Despite recognizing the safety and importance of vaccines, the Court stressed that the State cannot remain indifferent when families claim harm during a nationwide vaccination program.
In a key observation, the Court stated:
“The Constitution does not conceive of the State as a distant spectator to human suffering, but as an active guardian of welfare and dignity.”
The Court held that the absence of a uniform compensation mechanism creates a gap in the State’s welfare obligations.
Need for a No-Fault Compensation Framework
The Court noted that requiring affected families to prove negligence in civil courts would impose an excessive burden because vaccine injury claims often involve complex scientific causation.
It observed:
“To insist upon proof of negligence and fault in each case would impose an onerous burden upon affected families and would not be the best solution to those left affected.”
The judgment highlighted that many countries, including the United Kingdom, Japan, and Australia, have adopted no-fault vaccine injury compensation schemes that provide financial assistance without requiring proof of negligence.
Supreme Court’s Directions
After considering the constitutional issues, the Court issued the following directions:
- The Union Government must formulate and publish a no-fault compensation policy for serious adverse events following COVID-19 vaccination.
- Existing mechanisms for monitoring adverse events following immunization must continue.
- Relevant AEFI data must be placed in the public domain in a transparent and timely manner.
- No separate court-appointed expert body will be constituted, as the existing national and state AEFI committees are sufficient.
- The judgment does not prevent individuals from pursuing other legal remedies.
The Court also clarified that framing a compensation scheme does not amount to an admission of liability or fault by the government.
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