Frame No-Fault Compensation Policy For Adverse Events Due To COVID-19 Vaccination : Supreme Court Directs Centre

The Supreme Court on Tuesday directed the Union of India, through the Ministry of Health and Family Welfare, to frame a no-fault compensation policy for individuals who suffer serious adverse events following COVID-19 vaccination.

A Bench of Justice Vikram Nath and Justice Sandeep Mehta passed the direction while clarifying that the existing mechanism for monitoring Adverse Events Following Immunization (AEFI) shall continue to operate.

The Court further directed that relevant data regarding such adverse events should be periodically placed in the public domain, in accordance with the observations made earlier in the 2021 judgment in the Dr. Jacob Puliyel case.

At the same time, the Court clarified that no separate court-appointed expert body is required for examining vaccine-related adverse events, noting that the existing surveillance and monitoring framework will continue.

Importantly, the Bench clarified that the formulation of a no-fault compensation framework shall not be construed as an admission of liability or fault on the part of the Union Government or any other authority.

The Court also observed that the direction to create such a policy will not preclude affected persons from pursuing any other remedies available under law.

The Court delivered the judgment in a writ petition filed by Rachna Gangu and Venugopalan Govindan, who alleged that their daughters died due to adverse effects caused by the Covid vaccine.

The petitioners sought compensation from the Union Government for the deaths allegedly caused due to Covid-19 vaccines. They also sought constitution of an expert committee to inquire into the adverse effects of Covid vaccination.

Another petition was filed by the Union Government against an interim order passed by the Kerala High Court in a petition filed by Sayeeda KA (who alleged that her husband died due to vaccination) to formulate a policy for compensation.

In 2022, the Union Government had filed a counter-affidavit in the matter, arguing that it was not liable to compensate as vaccination was a voluntary act undertaken by persons who took an informed decision on the basis of the risks notified.

After extensive arguments on November 13 last year, Justice Nath had said that the Court would consider all submissions and decide on the amendment application (seeking an independent inquiry into vaccine-related adverse events and alleging systemic suppression of data during the COVID-19 vaccination drive) as well as the larger issues raised. "We will decide if a committee is to be formed, what directions to be issued...we will examine everything in great detail," Justice Nath said, reserving orders.

Senior Advocate Colin Gonsalves and Advocate Prashant Bhushan appeared for the petitioners.

Additional Solicitor General Aishwarya Bhati represented the Union.

Also from the judgment - Govt Data Shows COVID Vaccines Led To Some Deaths; State Cannot Shrug Off Responsibility: Supreme Court

Headnote

Constitution of India – Article 21 – Right to Life and Health – COVID-19 Vaccination – Adverse Events Following Immunization (AEFI) – Compensation Policy – The Supreme Court directed the Union of India to formulate a "no-fault" compensation framework for serious adverse events or deaths resulting from COVID-19 vaccinations - held that while the state-led vaccination program was a vital public health intervention, the State bears a positive obligation under Article 21 to ensure that families suffering grave harm are not left without an accessible mechanism for redress.

Constitution of India – Articles 14 and 21 – Judicial Review of Executive Policy – Separation of Powers – While acknowledging the executive's competence in drafting health policies, Supreme Court maintained that the separation of powers cannot prevent judicial intervention when fundamental rights are violated due to the absence of a structured relief framework in exceptional circumstances.

No-Fault Liability – Principle and International Precedent – Supreme Court emphasized that requiring proof of negligence through civil courts or consumer fora imposes an "onerous burden" on families in complex scientific matters - Relying on the principle of no-fault liability (similar to Section 164 of the Motor Vehicles Act, 1988), Supreme Court noted that global jurisdictions, including Australia, the UK, and Japan, have implemented dedicated COVID-19 vaccine injury compensation schemes - Supreme Court declined to appoint an independent medical board, finding the existing National and State AEFI Committees adequate for scientific assessment - it reaffirmed the state's duty to maintain transparent surveillance and ensure AEFI data is accessible in the public domain. [Relied on Jacob Puliyel v. Union of India (2022 SCC OnLine SC 533); In re: Distribution of Essential Supplies and Services During Pandemic (2021 SCC OnLine SC 372); Gaurav Kumar Bansal v. Union of India (W.P.(C) No. 539/2021); Paras 27-37]

Case Title: Rachana Gangu & Anr v. Union of India & Ors. – WP(C) No. 1220/2021, UNION OF INDIA v. SAYEEDA K.A. & ORS | SLP (C) No(s). 16452/2023 (and connected matters)