In a reply to a question in Parliament, the health ministry said, “There is no provision of compensation for recipients of Covid-19 vaccine against any kind of side-effects or medical complications.” While the government’s purchase order with vaccine-makers says the pharmaceutical firms will be liable for all adversities and refuses to indemnify them against any casualty, individuals will have to go to court to seek damages in case of serious adverse events, a senior official said.
“Unlike for clinical trials conducted in India where there are specific rules defining compensation for participants, there is no mechanism under the Drugs and Cosmetics Act to provide compensation against any adverse event after receiving a vaccine approved for restricted emergency use. Such people can explore legal options. In such cases, the liability will be of the vaccine-maker,” the official said. There are also other measures such as coverage of any hospitalisation due to an adverse event following immunisation (AEFI) under the health insurance policy facilitated by the insurance regulator.
While over 8 crore doses of vaccines were administered across India, very few adverse events have been reported so far. Till mid-March, around 79 deaths were reported in individuals who got the vaccines.
However, various public health groups such as All India Drugs Action Network have written to the health ministry, seeking clear-cut provisions for recipients of vaccines to seek compensation from firms in case of AEFIs.
Most countries, including the US, UK, Singapore and Canada, have mechanisms for compensation to those facing rare but serious adverse event after immunisation. While some countries ask companies to pay the compensation through an insurance, others like the US use a dedicated fund. In fact, the WHO’s Covax has a no-fault compensation allowing vaccine recipients to receive compensation without making them prove that the vaccine was the cause of the serious injury.