Covid-19 vaccines: Govt likely to grant indemnity to Pfizer, Moderna
PTI, Jun 2, 2021, 4:08 PM IST
New Delhi: As part of its bid to ramp up Covid-19 vaccine supply in the country, the Indian government is likely to grant indemnity against legal proceedings to foreign vaccine makers Pfizer and Moderna.
Quoting government sources, the news agency ANI said that the government is expected to grant indemnity against legal proceedings along the lines of what has been granted in other countries for Pfizer and Moderna vaccine companies if they apply for Emergency Use Authorisation (EUA).
The pharma giants had sought from the government indemnity from costs relating to severe vaccine side-effects. India has so far not given an indemnity to any COVID vaccine manufacturer against the costs of compensation for any severe side effects so far.
Meanwhile the Drugs Controller General of India (DCGI) has also waived the requirement of specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies, a move that will bolster availability of vaccines.
In a letter, DCGI Chief VG Somani said this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
“In light of the huge vaccination requirements and the need for increased availability of imported vaccines,… it has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing,” he said.
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