​Duty of care: On vaccine injury compensation programmes

The Supreme Court of India’s directive in Rachana Gangu to the Ministry of Health and Family Welfare to design a no-fault compensation scheme for serious adverse events following immunisation (AEFI) arising from India’s COVID-19 vaccination campaign marks a shift from a fault-based liability system to a no-fault one in state-run public health programmes. The case arose from writ petitions filed in various courts by families claiming that their relatives had died or suffered serious injury after receiving COVID-19 vaccines. Rachana Gangu was over the deaths, in 2021, of two women aged 18 and 20, allegedly from vaccine-induced immune thrombotic thrombocytopenia (VITT), a rare complication of the Covishield vaccine. Affected families contended that India had no dedicated mechanism to compensate those harmed in a state-run programme. For several years, the government resisted establishing a compensation policy because it held that vaccination was voluntary, serious AEFI rates were extremely low, and aggrieved citizens could sue vaccine manufacturers in civil court — a position the Court has since rejected as being impractical for ordinary individuals. The new ruling also builds on Jacob Puliyel (2022), in which the Court rejected challenges to emergency vaccine approvals but emphasised the need to make AEFI data publicly available.

In 2024, a few years after scientists had established the same concern in medical literature, AstraZeneca acknowledged in a U.K. court document that Covishield could, in rare instances, cause VITT. Since most Indians were vaccinated with Covishield, the admission further undermined the government’s position that links between the vaccine and certain deaths were unproven or coincidental. Despite operating one of the world’s largest immunisation efforts, India has historically lacked a dedicated national vaccine injury compensation programme. Many countries, including the U.S. and the U.K., have such vaccine injury compensation programmes where claimants need not prove negligence, but only a plausible link to vaccination. Even the global COVAX facility established a no-fault mechanism for 92 low- and middle-income countries. During the pandemic, the government had reported over 1,100 deaths following vaccination across 219 crore doses administered. The Court ruled that for a welfare state, these represent individual human lives and that the absence of a formal policy left affected families in a legal vacuum. It has also been clear that its directive is not based on adjudicating whether the vaccines caused specific injuries or deaths nor does it replace all fault-based liabilities in public health. However, it sets an important precedent for future vaccination drives, including the new one for HPV, affirming the state’s duty of care when endorsing medical interventions for the public good.