Indian companies, who are developing vaccines for the novel coronavirus, will be held responsible for any adverse effects or complications arising due to their vaccine.
The central government has not accepted their demand to indemnify them. As per the government order, the companies will be liable for all the adversities related to their vaccines, The Economic Times.
"Company shall be liable for all adversities as per CDSCO/Drugs and Cosmetics Act/DCGI policy/approval," the government's order read. The indemnity decision should be guided by the law and the courts of the day, the order further stated.
The purchase order issued to the vaccine makers by the Centre makes it mandatory for the companies to inform the government authorities immediately in case of reports of health risks or complications arising from the vaccine.
A senior official informed that the liability clause remains the same as for the other vaccination programmes - the concerned company is supposed to protect in case of any unexpected incident.
Many countries have shifted liabilities to the government, including the United States, United Kingdom, Canada, EU, Singapore, and WHO-led Covax. The government of these countries protects vaccine manufacturers from all lawsuits and bears the compensation burden.
In the US, the government has invoked a law that gives manufacturers immunity from lawsuits. According to the report, people with COVID vaccines related to adverse events (SAE) must file claims with the fund administered by the government. They will bear the compensation for vaccine damage under the Countermeasures Injury Compensation Program (CICP).
In the UK, the Health Department and Social Care would add COVID-19 vaccines to the list of jabs covered by Damages and Payments Act, according to which, the government will pay a fixed amount for anyone who unfortunately develops a permanent disability due to vaccination.
In the European Union, the government will pay compensation under specific conditions set out in the advance purchase agreements (APSs). The WHO would be developing a 'no-fault' compensation scheme for compensation-related issues.
Indian companies, including the Serum Institute of India (SII), have also requested the government to protect against all lawsuits. Last month, SII CEO Adar Poonawalla said manufacturers needed protection against all lawsuits for vaccines, especially during the pandemic.
His statement came weeks after a volunteer from Chennai alleged that he suffered adverse effects after the Oxford vaccine trails. The firm defended the legal notice they sent to the volunteer, saying they wanted to 'safeguard the reputation of the company which is being maligned.'
The vaccination drive in India will be starting from January 16. Most of the cities have received doses, with health workers being the ones to receive at first.