New Delhi: Pune-based Serum Institute of India (SII) has reiterated its demand for protection against legal action over any severe side effects arising out of its Covid-19 vaccines, calling for “same rules for everyone”.
The move came as the Narendra Modi government is in the last lap of discussions with the American vaccine maker Pfizer over its demand for indemnity. Another American firm, Moderna, has also made the same demand, which the government has so far refused to concede.
Indemnity is the legal bond that protects a company from being sued in case its vaccine ends up causing any side-effects. SII — the maker of Covishield and Covovax — was the first company in India to make this demand from the Modi government.
A source from the company said, “We are hoping that the rules will be the same for everyone.”
A top government official involved in the “active discussions” with Pfizer said that SII has reached the government again with its demand.
“Obviously, everyone will now ask for indemnity. This was one of the points due to which the government remained hesitant in granting indemnity to Pfizer. The discussions are on and if given (indemnity), it will be given to everyone. There is no point in cherry picking,” said the government official.
In December, SII chief executive Adar Poonawalla had said that “the government should indemnify vaccine manufacturers against all the lawsuits”.
“Apart from creating unnecessary fear in the minds of people against the vaccines…the manufacturers will go bankrupt (due to such legal notices). They also distract the manufacturers as they keep on explaining to the media what has happened,” he had said after his firm received a legal notice from a Chennai-based participant seeking compensation of Rs 5 crore alleging side-effects. The company countered this by filing a defamation notice against the trial participant.
Shortage of vaccines may induce govt’s U-turn
Battling an acute shortage of vaccines in the country, the Modi government is likely to grant indemnity to foreign vaccine makers, but subject to certain conditions.
“We may grant (indemnity) but with certain riders. These riders are still in discussions,” said the official quoted above.
The Modi government earlier stood firm against Pfizer’s demand, which led the company to withdraw its application for emergency use authorisation (EUA) in February despite being the first company to file for Covid vaccine approval.
However, now with the growing demand for vaccines and the looming threat of a third Covid wave, the government is looking at relaxing certain norms.
For instance, the country’s apex drug regulator Tuesday announced it was waiving the requirement of conducting post-approval bridging trials in India, also known as local trials. Apart from the demand of indemnity, waiver in local trials was one of the demands Pfizer insisted on before withdrawing its application.
Indian giant Cipla, on behalf of American vaccine maker Moderna, has also asked the government to provide confirmation on four critical points, including the grant of indemnity.
(Edited by Amit Upadhyaya)