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by sayum
11 March 2026 10:09 AM
"Non-disclosure of serious adverse events deprived citizens of information crucial to make an informed decision", While directing the Centre to frame a no-fault COVID-19 vaccine compensation policy, the Supreme Court of India made significant observations on the constitutional dimensions of informed consent in a State-led mass vaccination programme, noting that the government's public communication and administrative measures had created what petitioners described as an "atmosphere of effective compulsion" — stripping citizens of meaningful choice over a medical intervention that carried known, if rare, risks of death and serious injury.
The bench of Justices Vikram Nath and Sandeep Mehta, while not adjudicating individual claims of rights violations, acknowledged that the structural failure to disclose known adverse effects and the absence of any redress mechanism raised serious constitutional concerns under Articles 14, 19(1)(a) and 21 of the Constitution.
Background of the Case
The petitioners in Rachana Gangu v. Union of India — parents who lost two daughters aged 18 and 20 to post-vaccination complications including Cerebral Venous Sinus Thrombosis and Multisystem Inflammatory Syndrome — had argued before the Supreme Court not merely that their children died, but that they died without having been told the truth about the risks they were taking. Their case, joined by several connected petitions from Kerala involving deaths from intracranial haemorrhage, Thrombosis with Thrombocytopenia Syndrome, auto-immune encephalitis and paralysis, raised a wider systemic challenge: that India's entire vaccine governance regime during the pandemic was built on structural non-disclosure, administrative pressure, and the suppression of data that citizens had a constitutional right to access before consenting to vaccination.
The Compulsion Argument: When "Voluntary" Vaccination Is Not Voluntary
The petitioners squarely challenged the Union government's consistent position that COVID-19 vaccination was entirely voluntary. They argued that the distinction between formal voluntariness and actual compulsion had been entirely eroded in practice. Restrictions were placed on unvaccinated individuals covering travel, access to public spaces, and access to services — creating, as the petitioners put it, an "atmosphere of effective compulsion" that left citizens with no meaningful choice but to receive the vaccine irrespective of their individual autonomy or informed consent.
The Court acknowledged this submission as a serious constitutional grievance. The right to bodily integrity is a recognised facet of the right to life under Article 21, and the Court's jurisprudence has consistently held that meaningful consent to any medical intervention requires truthful risk communication. The petitioners argued that this was precisely what was denied: the Drug Controller General of India had publicly stated on January 4, 2021, that the vaccines were "110% safe," a declaration which, the petitioners contended, "contributed to a false sense of absolute safety and fundamentally undermined informed consent."
Suppression of Adverse Event Data: A Structural Violation
The petitioners placed before the Court a body of scientific evidence showing that by March-April 2021, approximately 18 European countries had suspended or restricted the administration of AstraZeneca — of which Covishield is a version — limiting its use to older age groups following multiple vaccine-induced deaths linked to blood clotting disorders known as VITT and TTS. The Indian government, they argued, despite having exclusive possession of all data essential for decision-making, neither published causality assessments in accessible form nor maintained a publicly available portal disclosing serious adverse events, in clear violation of the directions issued by this very Court in Jacob Puliyel v. Union of India.
This, the petitioners submitted, was not mere administrative failure — it was a constitutional violation. The government's control over AEFI data combined with the non-disclosure of serious adverse events "deprived citizens of information crucial to make an informed decision," engaging the right to information under Article 19(1)(a) as well as the right to life and health under Article 21. The denial of access to medical records in individual AEFI cases, the absence of diagnostic protocols, and the non-publication of causality assessments were all cited as compounding this structural violation. For the families of those who died or were disabled, the petitioners submitted, the absence of a compensation framework was not merely a policy gap — it was the final indignity in a sequence of constitutional wrongs.
The Government's Defence and the Court's Response
The Union of India maintained that its AEFI surveillance system was administered by leading scientific and medical experts at both State and National levels, that causality assessments were made public on the Ministry of Health and Family Welfare website, and that posters disclosing risks were displayed at vaccination centres in English and Hindi. It submitted that the rate of TTS events in India was 0.001 per one lakh doses — an "extremely rare occurrence" — and that allowing an independent review would "plant a seed of doubt in the existing regulatory system and harm public interest." It also relied on ICMR and AIIMS studies which had established no direct linkage between COVID-19 vaccines and sudden deaths.
The Court, while accepting the scientific findings of ICMR and AIIMS and reiterating that it was "neither adjudicating upon vaccine efficacy nor sitting in scientific review over the regulatory approval process," made a pointed constitutional observation: "The Constitution does not view the right to life solely through the lens of fault." Even accepting that the vaccination programme was lawfully approved and scientifically sound, the absence of a structured redress mechanism for the rare but acknowledged cases of grave harm raised constitutional concerns that could not be dismissed by pointing to the rarity of adverse events or the adequacy of scientific surveillance.
Article 21 Extends Beyond Fault: The Positive Obligation of the State
The Court held that Article 21 embodies a positive obligation of the State to ensure that "where grave harm is alleged to have occurred in the course of a State-led public health intervention, affected families are not left without any accessible mechanism of redress." This obligation, the Court emphasised, flows not from any finding of negligence or illegality but from the State's very decision to undertake a mass intervention in the exercise of its public health duty. "The vaccination program undertaken during the pandemic was itself an expression of these constitutional commitments," the Court observed, but "it cannot be brushed aside that the same vaccines also led to loss of life."
Invoking the Directive Principles under Articles 41 and 47, the Court held that the State's duty to provide public assistance in cases of sickness and disablement, and its primary duty to improve public health, are not aspirational platitudes but constitutional anchors for a welfare-state response. Drawing on the Bhopal Gas Tragedy jurisprudence — where the Court had described it as "a compelling duty, both judicial and humane, to secure immediate relief to the victims" — the bench reiterated that the judiciary's constitutional duty to safeguard fundamental rights cannot be eclipsed by the separation of powers when those rights are violated by executive action or, as in this case, by executive inaction.
The Court's observations on informed consent, administrative compulsion, and the constitutional dimensions of AEFI data disclosure, while stopping short of specific findings on individual rights violations, lay a significant jurisprudential foundation. The direction to frame a no-fault compensation policy was itself premised on the acknowledgment that requiring affected families to prove negligence in individual proceedings would impose an "onerous burden" inconsistent with Article 14's guarantee of equality. The Court made clear that the State's responsibility in a mass immunisation programme is not discharged by surveillance alone — it must extend to transparent risk communication before vaccination and fair, accessible redress after it.
Date of Decision: March 10, 2026