Serum Institute of India (SII), the manufacturer of Covishield, has asked for indemnity from liability, saying all vaccine makers, whether Indian or foreign, should be granted the same protection.
“Not just Serum Institute of India (SII), all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted it," Serum sources said on Thursday. The move comes after Pfizer and Moderna urged the Centre to waive off the indemnity clause to aid the vaccine process in India.
The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects.
Sources in the Centre on Wednesday said the government may grant indemnity from liability to Pfizer and Moderna to speed up approvals for the vaccines in India.
A top official with the government has said that “there is no issue” in granting indemnity to the two giants in India and the approval will be in line with the approach taken by US and other countries administering both vaccines.
Pfizer, which is ready to offer an undisclosed number doses to India between July and October, had in talks with the government stressed on indemnity, sharing efficacy trials and approvals for its vaccine in various countries and by WHO. Pfizer has immunity in countries like the US where it cannot be sued for any adverse effects.
In yet another shot in the arm for the vaccine process, foreign jabs approved by specific countries and WHO for emergency use will not need bridging trials in India, the Drug Controller General of India (DCGI) said on Wednesday.
The exemption will, however, be limited to COVID-19 vaccines approved in India for restricted use in emergency situation which are already approved for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing (EUL) and which are well established vaccine from the stand point that millions of individuals have already been vaccinated with the said vaccines.