COVID-19 Vaccine Adverse Events: Supreme Court Directs No-Fault Compensation Policy for India

The Supreme Court of India has directed the Union government to frame a no-fault compensation policy for individuals who suffer serious adverse events following COVID-19 vaccination. The ruling, in Rachna Gangu v. Union of India, marks a significant development in Indian public health law and addresses a gap that had left vaccine-injured individuals without a defined legal remedy. The absence of a statutory compensation framework had forced those who suffered adverse events to pursue expensive and uncertain tort litigation, creating a chilling effect on vaccine uptake and leaving genuine victims without redress.

The Gap in India's Vaccine Compensation Framework

Unlike several other jurisdictions including the United States, United Kingdom, and members of the European Union, India does not have a comprehensive vaccine injury compensation programme. Under a no-fault compensation scheme, an individual who suffers a recognised adverse event following immunisation does not need to prove negligence by the vaccine manufacturer or the administering health worker. The scheme acknowledges that some adverse events are statistically unavoidable consequences of large-scale vaccination programmes, and that the state has an obligation to provide redress to those individuals as a matter of public health policy and constitutional right to health.

What the Supreme Court Directed

The Court held that the right to health under Article 21 of the Constitution, read with the government's active role in promoting and mandating vaccination during the COVID-19 pandemic, creates a corresponding obligation to provide compensation to those who suffer serious harm from that vaccination. The Court directed the Ministry of Health and Family Welfare to constitute an expert committee to frame a no-fault compensation policy within a specified timeframe, to identify categories of compensable adverse events, to set compensation amounts by category, and to establish a streamlined claims process that does not require affected individuals to prove negligence.

Implications for Public Health Law

This ruling has broader implications beyond COVID-19 vaccines. If the government frames a general no-fault compensation policy for vaccine adverse events, it would represent a structural shift in how India approaches the state's duty of care in public health programmes. It would also align India with international best practices on vaccine pharmacovigilance and adverse event reporting, since a functioning compensation scheme incentivises proper reporting of adverse events by healthcare workers and affected individuals. The ruling may also prompt the legislature to consider a statutory framework, as opposed to a policy-based approach which would be more vulnerable to future withdrawal.

What Affected Individuals Should Know

Individuals who suffered serious adverse events following COVID-19 vaccination and have not been compensated should monitor developments in the implementation of this directive. Once the policy is framed, claims procedures will need to be followed as specified. In the interim, individuals may still pursue civil remedies for negligence in vaccine administration, though these remain difficult to establish without specific evidence of deviation from standard protocols. Healthcare providers who administered vaccines should ensure their records are complete and accurate, as these will be relevant both to compensation claims and to the broader adverse event reporting system.