In the midst of talks about prospective legal protection for international vaccine makers Pfizer and Moderna in India for their COVID-19 vaccines, SII has also sought liability protection.
The Serum Institute of India (SII) has sought legal protection against liabilities, sources said on Thursday, amid discussions over possible legal protection for international vaccine producers Pfizer and Moderna over their COVID-19 jabs in India.
“Not just the Serum Institute of India, but all vaccine firms should be given liability indemnity protection if overseas businesses are given the same.”
SII CEO Adar Poonawala urged for vaccine producers to be indemnified earlier this year.
“We need the government to defend producers, particularly vaccine producers, in all disputes… There are frivolous claims made, and you see something being blown out of proportion in the media. The government must intervene with the appropriate messaging “he had stated.
In the midst of a statewide COVID-19 vaccine shortage, Pfizer, the world’s largest pharmaceutical company, is seeking an indemnity bond that will protect it from legal lawsuits if the vaccine causes any side effects.
Dr VK Paul, a member of the NITI Aayog’s Health Committee, said on May 27 that the government is still looking at the American pharmaceutical company’s request for indemnity.
“We’re looking into this request and will make a judgement based on the best interests of the people. This is still being debated, and no decision has been made as of yet “he had stated
Dr Nirmal K Ganguly, former ICMR chief, said on Wednesday that no corporation in India’s vaccination history has ever paid indemnity, and the government, which is the largest purchaser of vaccines, hasn’t either.
Specific studies of COVID-19 vaccines that have been approved by various foreign regulatory authorities had previously been exempted by the Drugs Controller General of India (DCGI). Foreign COVID-19 vaccines from Pfizer and Moderna are likely to benefit from this.
The decision will apply to vaccinations that have already been licenced for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan, or are listed for Emergency Use by the World Health Organization, according to DCGI Chief VG Somani in a letter.