Serum Institute and Bharat Biotech to Pay Damages in Case of Adverse Reaction, Inform Govt as Well: Centre
A vial of the COVID-19 vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca is checked. (Gareth Fuller/Pool via AP)
In a significant decision, the Centre has taken a call to not extend indemnity to vaccine developing companies who have got emergency use authorisation for their 'Covaxin' and 'Covishield' jabs.
Both Bharat Biotech International Limited and Serum Institute of India will be liable to pay damages, News18 has learnt from reliable sources.
The purchase agreement says that the company shall be liable for all adversaries as per CDSCO/Drugs and Cosmetics Act/ DCGI Policy/approval. "Companies also have to inform the government in case of serious adverse advents," reads the contract of BBIL. The purchase agreement has spelt this out clearly.
A highly placed source had told News18 that extending indemnity was 'out of question'. The query was specifically regarding the Government of India's talks with Pfizer that has insisted on indemnity in India, similar to the kind it got in the UK.
Adar Poonwalla, CEO of Serum Institute, had said that the company needs government to indemnify vaccine makers against all lawsuits. He had said that when "frivolous claims crop up and are blown out of proportion, it affects the confidence of not just anti-vaxxers, but the general public too."
Both BBIL and SII had raised this issue several times with the regulator saying that given the exceptional circumstances under which the vaccine had been developed, the makers would expect relief on this front. Clearly, the government did not relent.