The Supreme Court on Tuesday (March 10) directed the Centre to formulate a “no-fault” compensation policy for individuals who suffered serious adverse effects or died after receiving Covid vaccines. The court ruled that families should not be forced to prove negligence in civil courts to claim relief for vaccine-related injuries. Instead, it held that the State’s constitutional obligation to protect public health extends to providing a structured compensation mechanism for those who suffered grave outcomes during a state-led vaccination drive.

Vaccine complications

The court was hearing a batch of petitions led by people who lost their children or spouses — all aged between 18 and 40 years — to rare complications, such as blood clotting disorders, shortly after receiving the Covishield and Covaxin vaccines in 2021. The petitioners argued that the government failed to ensure informed consent and transparently communicate the risks associated with the vaccines. According to them, the vaccination drive, while officially voluntary, was effectively made mandatory through various administrative restrictions on unvaccinated individuals, thereby violating their fundamental rights.

The Union government, in its defence, argued that the vaccines underwent rigorous regulatory approvals and that the existing system for detecting Adverse Events Following Immunisation (AEFI) was robust.

The government maintained that vaccine-related deaths were extremely rare, citing a reporting rate of just 0.001 per one lakh doses in India for certain clotting disorders. It contended that aggrieved families already had a legal remedy: they could approach civil or consumer courts to claim damages for negligence or malfeasance against vaccine manufacturers.

The Bench, comprising Justices Vikram Nath and Sandeep Mehta, rejected the government’s suggestion to let families approach lower courts individually. It noted that vaccine injury claims involve complex scientific attribution. Insisting on proof of negligence, the Bench noted, “would impose an onerous burden upon affected families and would not be the best solution to those left affected.” Forcing citizens into a multiplicity of individual legal battles would also risk inconsistent outcomes and unequal access to relief, which undermines the guarantee of equality under Article 14 of the Constitution, it held.

To resolve this, the court invoked the legal principle of “no-fault liability”, which means that a victim or their family can receive financial relief without having to prove that the injury was caused by someone’s negligence or intentional wrongdoing. The court noted that this principle is already recognised in Indian law, such as in motor vehicle accidents, and is a standard feature of vaccine injury schemes in countries like Australia, the United Kingdom and Japan.

The judgement relied on Article 21 of the Constitution, which guarantees the right to life, including the right to health. The court stated that the Constitution “does not conceive of the State as a distant spectator to human suffering, but as an active guardian of welfare and dignity.” It ruled that since the mass vaccination programme was a State-led public health intervention, the State bears a positive obligation to support those who suffered grave outcomes, “no matter how rare they are.”

The court clarified that it was not sitting in scientific review of the vaccines. It referred to its 2022 judgement in Jacob Puliyel vs Union of India, in which it had upheld the legality of the vaccine approval process and the government’s AEFI monitoring mechanisms while ruling that bodily integrity is protected under Article 21 and no individual can be forcefully vaccinated.

Relying on the judgement, the court refused to set up a separate expert medical board to investigate the deaths, stating that existing AEFI committees were adequate. However, it stressed that the State’s responsibility “cannot end at surveillance alone, but must extend to providing fair compensation.”

The apex court directed the Ministry of Health and Family Welfare to expeditiously formulate and publish a no-fault compensation framework to address serious adverse events arising from the Covid-19 vaccination drive, while clarifying that this policy shall not be construed as an admission of liability or fault by the Union government.

Tuesday’s judgement mirrors the Supreme Court’s earlier intervention during the pandemic regarding compensation for Covid-19 deaths. In the 2021 case of Gaurav Kumar Bansal vs Union of India, the court was tasked with deciding whether families of those who died of the virus were entitled to financial relief.

In that case, the petitioners relied on the Disaster Management Act, 2005, which states that the national authority “shall recommend guidelines for the minimum standards of relief”, including ex gratia assistance for loss of life.

While the Centre initially expressed its inability to pay a specific amount due to financial constraints and competing priorities, the Supreme Court ruled that the word “shall” in the law must be construed as a “mandatory statutory duty”. The court directed the NDMA to “recommend guidelines for ex gratia assistance on account of loss of life to the family members of the persons who died due to Covid-19,” leaving the exact reasonable amount to be decided by the authority.

Following this directive, the NDMA notified guidelines in September 2021, fixing an ex gratia amount of Rs 50,000 per deceased person, to be disbursed by states from the State Disaster Response Fund. To ensure no family was unfairly denied relief, a simplified procedure was established where deaths occurring within 30 days of a positive test were treated as Covid-19 deaths and district-level grievance redressal committees were set up to resolve any disputes over death certificates.