Liability for COVID vaccines in India: Where does the buck stop?

A month into Indias country-wide vaccination drive that began in January 2021, and we have reportedly seen the death of 27 people already, including that of a 24-year-old medical intern, a mere 11 days after her vaccination. The Indian Government, through its consent letter, is said to have held the manufacturers liable for any and all adverse effects stemming from their vaccines, however, all consumer claims will ultimately be determined by the courts. With a petition filed before the Madras High Court to declare one of the vaccines unsafe, it becomes imperative to understand where accountability – and ultimately liability lies, for adverse effects stemming from COVID-19 vaccines.

The Central Drugs Standard Control Organisation (CDSCO) has granted permission to two COVID-19 vaccines for restricted usage in emergency situations, in India. Covaxin – developed and manufactured by Bharat Biotech India Limited, in collaboration with the Indian Council of Medical Research, and Covishield – developed by AstraZeneca in partnership with the University of Oxford, and manufactured by the Serum Institute of India, Pune.

Statutory liability of manufacturers and sellers of vaccines has been specifically provided for, in the Drugs and Cosmetics Act, 1945, and in the New Drugs and Clinical Trial Rules, 2019 (Rules). Liability is also attributable to manufacturers and sellers through general legislation such as the Consumer Protection Act, 2019 and the Indian Penal Code, 1860.

The Rules impose liability upon pharma manufacturers for serious adverse effects caused to subjects in clinical trials. The CDSCO is the central authority that authorises such trials and decides compensation for serious adverse effects in clinical trials. Compensation that is sought post-trial is covered by the principle of product liability under the Consumer Protection Act, 2019.

Product Liability is the responsibility of a product manufacturer or seller to compensate for any harm caused to a consumer for defective products manufactured or sold. A manufacturer is liable if harm is caused due to (i) a manufacturing defect, (ii) deviations from specifications, or (iii) inadequate usage instructions. Similarly, a seller is liable where the seller exercises control over testing, manufacturing, packaging, labelling, or modification and any of these actions lead to harm, or a failure to conform to an express warranty made to consumers.

While the Government has assured medical care and compensation will be provided in consent forms, this liability has been shifted to the sponsor, Bharat Biotech, for any serious adverse effect linked to their vaccine, Covaxin. Countries such as the UK and the US have set up well-defined compensation and damages schemes for public vaccines that ensure government participation in sharing the liability on vaccine administration for COVID-19, and even provide civil immunity to manufacturers, in some cases. A joint and shared responsibility of the Government and manufacturer would not only protect the interests of the vaccine participants but also safeguard the manufacturer to a reasonable extent.