Key Developments
The Supreme Court ruled that the State must not evade responsibility for deaths or serious injuries alleged to have occurred after COVID‑19 vaccination. A bench of Justice Vikram Nath and Justice Sandeep Mehta directed the Union Government to devise a no‑fault compensation policy for serious adverse events.
Background of the Petitions
The case originated from the writ petition Rachana Gangu v Union of India, filed by families claiming deaths or severe medical conditions post‑vaccination. Similar petitions were pending in the Kerala High Court, which also asked for a compensation framework. The Union Government challenged the interim direction, leading the Supreme Court to consolidate the matters.
Petitioners' Contentions
- Structural gaps in India’s vaccine governance, especially in transparency, informed consent, and post‑vaccination surveillance.
- Although vaccination was formally voluntary, travel and public‑space restrictions effectively made it compulsory.
- International studies linking the AstraZeneca platform (used for Covishield) to rare clotting disorders were not adequately disclosed.
- Absence of an effective redressal mechanism for families of deceased vaccine recipients.
Union Government’s Response
- Vaccines were approved after rigorous scrutiny by the CDSCO and expert committees.
- India already operates an AEFI framework.
- Incidence of serious complications like thrombotic thrombocytopenia syndrome is extremely rare.
- Victims could pursue civil or consumer‑court remedies for negligence.
Court’s Analysis & Reasoning
The Court clarified that it was not questioning vaccine efficacy or the regulatory approval process (the 2021 Jacob Puliyel decision upheld the approvals). Instead, it examined whether the lack of a uniform redressal mechanism violated the constitutional guarantee of Article 21. The judgment emphasized that the right to life is not merely fault‑based; the State has a positive obligation to ensure accessible relief for citizens harmed during a State‑led public health intervention.
Relying on comparative law, the Court noted that countries like the United Kingdom, Australia and Japan have established no‑fault vaccine injury compensation schemes, enabling swift relief without protracted litigation.
Directions Issued
- The Ministry of Health and Family Welfare must frame and publish a no‑fault compensation policy for serious adverse events following COVID‑19 vaccination.
- Existing AEFI monitoring mechanisms shall continue, with periodic public disclosure of data.
- No separate court‑appointed expert body is required; current AEFI committees are sufficient.
- The policy does not constitute an admission of liability; aggrieved parties may still pursue other legal remedies.
Exam Relevance
This judgment is pivotal for GS 2 (Polity) as it interprets the positive dimension of Article 21. It also touches upon GS 3 (Economy) through the design of a compensation scheme, and GS 4 (Ethics) by highlighting the State’s moral responsibility during a public health crisis. Aspirants should link this case to the broader discourse on health governance, disaster management, and the balance between individual rights and collective welfare.
Way Forward
Implementation will require:
- Drafting clear eligibility criteria and quantum of compensation.
- Strengthening the AEFI reporting network for timely data collection.
- Ensuring transparency so that citizens are aware of the compensation process.
- Periodic review to align the scheme with evolving scientific evidence.
Effective execution will reinforce public trust in vaccination drives and set a precedent for handling adverse events in future mass‑health interventions.
