Indemnity clause: Serum Institute of India knocks on govt door again

Amid adverse events following vaccination coming from across the country, Pune-based vaccine maker Serum Institute of India (SII) again raised the issue of indemnity in a meeting with the health ministry this week, said someone close to the development.

SII did not wish to comment on the matter. While there are reports of adverse events, no causal link to the vaccine has been established. SII Chief Executive Officer Adar Poonawalla earlier indicated legal indemnity was required to ensure that the vaccination drive could be completed smoothly.

In an interview with Business Standard, Poonawalla, who is also president of the Indian Vaccine Manufacturers Association, had said an indemnity clause during the period of the pandemic would ensure the vaccination drive did not halt if there was an injunction. 

“If there is an injunction and the court says that no more vaccines will be given to anyone pending further enquiry, many lives would be impacted. It is not about the financial loss to the company. The entire government programme, too, stops. Some very high-level constitutional powers would have to be invoked to overrule such a situation. This has never been tested in our history,” he had said.

Legal experts say the government is unlikely to indemnify vaccine makers. The expert panel of the Central Drugs Standard Control Organisation (CDSCO) will review the adverse events and the reports (analyses) submitted by vaccine makers. Only in case of any causal link established between any adverse event and the vaccine would the CDSCO take up the issue.

The vaccines of SII and Bharat Biotech have been approved under the New Drugs and Clinical Trial Rules, 2019, which come under the Drugs and Cosmetics Act, 1940. In this Act, there is provision for compensation in the case of any adverse event in a trial. 

SII’s Covishield and Bharat Biotech’s Covaxin are being given to health care workers now. Both the firms have listed on their websites adverse effects that can happen after vaccination and who should avoid taking the vaccine.