According to The Indian Express, while the exact quantity of doses to be imported by Cipla is still under consideration, the vaccine is initially expected to be provided to India in limited quantities — as donations by the US drugmaker.
The Drugs Controller General of India (DCGI) on Tuesday approved Cipla’s request to import the Moderna vaccine by granting it the Emergency Use Authorisation (EUA) making it the fourth vaccine to be available in the country.
With this, Moderna becomes the first internationally developed vaccine to be approved in India without a bridging trial.
— Ramesh Bala (@rameshlaus) June 29, 2021
Confirming the emergency use approval to Moderna’s mRNA Covid-19 vaccine, Dr V K Paul, head of the national COVID task force, on Tuesday said, “I am pleased to inform that an application received from Moderna, through an Indian subsidiary and partner of theirs, Cipla, has been granted new drug permission for restricted use, commonly known as Emergency Use Authorisation. This is the first internationally developed vaccine for which such permission exists as of today,” Paul said.
According to The Indian Express, while the exact quantity of doses to be imported by Cipla is still under consideration, the vaccine is initially expected to be provided to India in limited quantities — as donations by the US drug maker.
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Asked about indemnity from legal costs for foreign developers, including Moderna and Pfizer have sought, Paul said, “That is under consideration and is being addressed.”
“Cipla Limited is supporting Moderna, Inc. with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies,” Cipla told the Bombay Stock Exchange on Tuesday night.
Moderna’s vaccine can be stored at 2-8 degrees — a range that suits India’s cold storage requirements under the Universal Immunization Programme — provided unopened vials of the vaccine are stored for less than 30 days.