India’s legal and judicial history on vaccine injury compensation is sparse, as there is no codified vaccine compensation program and relatively few reported cases prior to COVID-19. The current scenario is that individuals alleging vaccine injury or death must seek redress through civil suits or consumer courts, typically on grounds like negligence or defective product, which can be expensive, protracted, and uncertain. Legal experts note that establishing causality and fault in such cases is an extremely challenging task, often requiring extensive scientific evidence. Two cases from earlier decades illustrate the hurdles:
· In Dr. Durga Nursing Home vs. K. Dhanasekaran (2003), a petitioner in Tamil Nadu approached the consumer court after a child allegedly suffered harm due to an expired or improperly stored vaccine. The case went through district and state consumer fora. Ultimately, the nursing home was found to have deficient services (poor cold storage and lack of emergency facilities) and was made to pay compensation for the injury not because of an inherent vaccine defect, but due to negligence in administration and handling. This underscores that traditional legal recourse in India frames vaccine injury as an issue of fault or malpractice, not a no-fault accident.
· In another case in Gujarat (as referenced in legal literature), a person who suffered a permanent disability allegedly from a routine triple antigen vaccine was initially awarded compensation by a trial court, but on appeal the High Court reversed that award about 15 years later. The High Court held that the petitioner failed to conclusively establish that the vaccine caused the injury or that there was negligence, and thus the claim was dismissed. This demonstrates the onus on the claimant in the tort system to prove a direct causal link and fault, which can be a nearly insurmountable barrier in vaccine cases due to scientific complexities. By the time the case concluded, a decade and a half had passed – highlighting how time-consuming litigation can be for claimants.
Prior to the COVID-19 litigation, one significant matter concerning vaccines in the Supreme Court was a 2013 civil writ petition by the advocacy group SAMA and others, related to the human papillomavirus (HPV) vaccine trials conducted in India. That petition was filed after the deaths of seven girls during a post-licensure observational study of HPV vaccines, and it demanded, among other things, compensation for the bereaved families. As of the latest updates, that case has remained pending in the Supreme Court for years with no final decision on compensation. This again indicates the slow pace and uncertainty of seeking relief through courts.
When it comes to COVID-19 vaccines, the petitions of people like Sayeeda K.A. and Rachana Gangu are the first major legal challenges in India pressing for a structured compensation approach. There isn’t yet a binding precedent from the Supreme Court specifically holding the government liable to compensate for a vaccine’s side effects. In fact, the government’s affidavit in the Rachana Gangu case explicitly asserted that it cannot be held liable in tort for approved vaccines and that those who take the vaccine do so with an understanding of the risks, however minimal. The Supreme Court itself, in a May 2022 judgment on vaccine mandates (Jacob Puliyel vs Union of India), upheld the voluntary nature of COVID vaccination and noted that while serious AEFIs should be recorded and investigated, it did not direct any compensation mechanism at that time – likely because the issue of compensation was not squarely before it in that case. Instead, the Court in Puliyel suggested that individuals maintain the right to seek remedies in civil law for vaccine injuries, implicitly leaving the question of compensation to be handled through those conventional channels or future policy.
Given this landscape, the Kerala High Court’s 2022 order was unprecedented in India – it was perhaps the first time a court mandated the government to create a compensation policy for vaccine injuries. Although that order was stayed, it set the stage for the ongoing Supreme Court deliberation. Legal scholars have argued that the Indian legal system’s traditional approach (relying on tort litigation) is inadequate for vaccines, and they have called for a “no-fault” compensation scheme to fill this void. They point out that the tort system’s requirements of proving fault or defect are ill-suited to vaccines, where adverse outcomes are typically rare and not due to manufacturer negligence but biological chance. Indeed, even in countries with established compensation systems, causation can be hard to prove scientifically, but those countries still “continue to uphold the State’s responsibility towards people who suffer injury or death” from vaccines. This reflects an ethical stance that India’s courts are now grappling with: should the burden of uncommon vaccine harms be shifted from individuals to the state (and by extension society), given that vaccination is encouraged for the common good?
In summary, legal precedent in India offers little direct relief for vaccine injuries. Past cases show that without a dedicated scheme, claimants face protracted litigation with high uncertainty. The Supreme Court’s current engagement with the issue could, depending on its outcome, set a significant precedent – either by nudging the creation of an administrative compensation mechanism or by reaffirming that claimants must rely on existing legal processes. The hearing on this matter is a test of how Indian law will evolve to address the rights of the very small minority adversely affected by vaccines in a mass immunization drive.
