New Delhi: The Indian government has allowed the export of 5 doses of Covovax Crore, Covid-19 vaccine produced in it in it by the Serum India Institute (SII), because Jab has not been approved for emergency use in the country, the official source said on Monday.
SII’s main drugs have been allowed to export 50 lakh vials, equivalent to a dose of 5 crores, from Covovax to Indonesia, they said.
According to these sources, SII submitted an application to the Indian General Medicine Controller (DCGI) which searched for an emergency use authorization grant for Covovax on May 21 and was still awaiting approval from the drug regulator.
Recently, Prakash Kumar Singh, Director, Government and Regulatory Affairs in SII, wrote to DCGI who are looking for certification of objections to exporting a 50 lakh bottle.
He also stated that a dose of the crore vaccine produced by the company will end in December this year, the official source said.
“M / s PT Indofarma Tbk, Indonesia wants to buy this number and they have issued a purchase order of 50 lakh vials to us.
If we cannot export this number, then it will be an international waste that is very much needed – has a Covid-19 vaccine for Pandemic, “The official source quoted Singh as stated in the application.
The expiration date around one dose of crore from the Covovax vaccine was December 2021, he said.
This export will not affect Covid-19 vaccine equipment to India because the large stock of covishield is available to meet the requirements of the country, Singh is studied to be delivered.
DCGI has referred to this issue to the Ministry of Health Union for approval and after the ministry intervention, DCGI provides NOC exports to SII without EUA India, said the source.
The DCGI office has given SII permission to produce and provide Covovax on May 17 after Pune-based companies produced and are stockpiled by vaccine doses.
In August 2020, US-based vaccine makers Novavax, Inc.
has announced a license agreement with SII for the development and commercialization of the NVX-COV2373, Covid-19 vaccine candidate, in low and medium and medium and medium and Indian countries.