BackCipla gets authorisation for restricted use in India of donated Moderna vaccines
Foreign vaccine makers have been urging the government to provide indemnity for vaccines in India, which would mean that the government would be liable to pay for serious vaccine-related injuries instead of the company
PremiumNEW DELHI: Pharmaceutical giant Cipla Ltd has received an import licence for restricted emergency use of Moderna’s covid-19 messenger RNA vaccine in India which have been donated by the US-based firm.
“An application received from Moderna through an Indian partner, Cipla, has been granted new drug permission for restricted use, which is commonly known as emergency use authorisation... This new drug permission for restricted emergency use is now in operation," Vinod K. Paul, member (health) at NITI Aayog and chairman of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), said at a press conference.
The vaccine will be used as part of donations from the company to India, which will be done through Cipla, and not from a commercial pact.
“Cipla is just facilitating import of vaccines in India for Moderna for their donated quantities. As of now, they do not have a commercial pact," one of the two people said.
It is not yet clear how many doses Moderna is donating to India and whether it will be distributed in the country through government or private channels. A spokesperson for Mumbai-based Cipla said they would be issuing a statement later today.
The authorisation was given under norms that were revised in India, which allowed accelerated authorisation for covid-19 vaccines that had received authorisations from either of four top regulators--US Food and Drug Administration, European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency or Japan’s Pharmaceuticals and Medical Devices Agency--or the World Health Organization.
Foreign vaccine makers have been urging the government to provide indemnity for vaccines in India, which would mean that the government would be liable to pay for serious vaccine-related injuries instead of the company. Paul on Tuesday said that discussion about it are still ongoing.
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