The health ministry has told the Supreme Court that making the government compensate for deaths due to adverse events after Covid-19 immunisation is “not legally sustainable”.

The ministry, in an affidavit filed in response to a petition seeking compensation for immunisation-related death, said that it has never forced any citizen to take vaccines. It added that the exercise was voluntary.

The affidavit added that compensation can only be given by a manufacturer when the vaccines are being tested in clinical trials. People getting immunised after the market authorisation have to seek compensation individually in civil courts, the government said.

India rolled out its adult vaccination programme against Covid-19 in January 2021, a year after the pandemic broke out globally. Till November 19, more than 219 crore doses have been administered across the country. There have been 92,114 cases of adverse events following immunisation (AEFI), or side effects to vaccines. Of these, 2,782 were serious and severe in nature. The government has maintained that not all of them are linked to vaccination.

In October 2021, Hyderabad-based Rachana Gangu and Coimbatore-based Venugopalan Govindan filed a writ petition in the Supreme Court demanding significant monetary compensation following their daughters’ deaths.

Gangu’s daughter Rithaika Omtri died in June 2021 in Hyderabad within a fortnight of taking a Covishield shot. Her death was later confirmed to be linked to the Covishield vaccine by a national committee that looks into cases of adverse events.

Govindan’s daughter Karunya, aged 20, died in July 2021 within a month of vaccination in Coimbatore. The national committee could not find sufficient evidence to link her death with vaccination.

In the petition, the parents demanded that the government establish a protocol for early detection and treatment of adverse events and that it set up an expert medical board to investigate their daughters’ deaths.

In August, the Supreme Court issued a notice to the Centre asking it to respond to the writ petition. The Union government submitted its response on November 25.

Asking the court to dismiss the petition, the government said that the adverse event monitoring, investigation and analysis system is adequate and transparent. It added that an independent review of the deaths of the petitioner’s children would cast doubts on the existing AEFI mechanism.

So far, India has approved 12 vaccines against the Covid-19 virus. Covishield has accounted for the bulk of immunisation. The ministry said that it had released details of the side-effects of Covishield and the possibility of death through its website, press releases and various news articles in PTI.

“Therefore any person taking vaccine has to verify said information and then decide whether to get vaccines or not,” the affidavit stated.

In their petition, Gangu had claimed that no information was provided by the Hyderabad vaccination centre about possible adverse events after immunisation.

The government has, however, stated that this is an incorrect submission and that question of informed consent does not come in cases of voluntary vaccination. In its affidavit, the health ministry has put the onus of deriving more information on the vaccine recipients.

“A vaccine beneficiary always has the option to access even more information about the vaccine and its possible adverse effects from the health workers at the vaccination centre or their doctor before making an informed decision on their own,” the affidavit said. “Once a vaccine beneficiary who has access to all relevant information, voluntarily chooses to enter a vaccination centre and receive vaccination, the question of lack of informed consent does not arise.”

Rithaika Omtri died in June 2021, a fortnight after receiving her first Covishield shot. She suffered vaccine-induced thrombotic thrombocytopenia.

Govindan, the co-petitioner, said the government’s response in court was shocking. “In the affidavit, the government claims that adverse events such as blood clots were publicised and people knew,” he said. “But the fact is that the government publicised the vaccines as completely safe and effective without any riders, misleading people like us and sending my daughter and many others to their untimely deaths.”

After his daughter’s death, Govindan claimed that they tried approaching the government. However, they were met with callous responses and the AEFI process was in shambles, he alleged.

He also said they will file a response to the government’s affidavit to counter each point.

Several experts have pointed towards a poor AEFI system in India which has led to underreporting of adverse events. Countries like Argentina, Brazil, Canada, Colombia, Chile, and Paraguay have reported a higher rate of AEFI due to Covid vaccines.

Rushil Tamboli, from the Awaken India Movement, which has been pushing for better government response to adverse events and has helped families seek legal action, said that the government has forced states to take certain actions to mandate vaccination.

“The government has lied about its efforts to raise awareness. The information is limited and difficult to find on their website,” Tamboli said. “For compensation they are asking families to reach out to civil courts, and that the government will not be responsible to provide any compensation… in a sense they are shirking away from their own responsibility.”

Gangu, the main petitioner, told that the government is not been transparent about recording and reporting adverse events in her daughter’s case. She and her husband had to file three right to information queries with the Karnataka government and the Centre to get information on Rithaika’s death.