DCGI allows Cipla to import Moderna's COVID-19 vaccine for restricted emergency use

At present, the country is administering Covishield developed by AstraZeneca and manufactured by the Serum Institute of India, Covaxin developed and manufactured by Hyderabad-based Bharat Biotech, and Sputnik V developed by Gamaleya Research Institute and exported as well as manufactured by Dr Reddy's Laboratory.

By Newsmeter Network  Published on  29 Jun 2021 11:38 AM GMT
DCGI allows Cipla to import Modernas COVID-19 vaccine for restricted emergency use

Hyderabad: India on Tuesday made way for the fourth COVID-19 vaccine after Mumbai-based pharmaceutical company Cipla got the approval from the Drugs Controller General of India (DCGI) to import Moderna vaccine for restricted emergency use in the country.

At present, the country is administering Covishield developed by AstraZeneca and manufactured by the Serum Institute of India, Covaxin developed and manufactured by Hyderabad-based Bharat Biotech, and Sputnik V developed by Gamaleya Research Institute and exported as well as manufactured by Dr Reddy's Laboratory.

Cipla, on behalf of the US pharma major Moderna, requested the drug regulator for import and marketing authorization for the vaccine.

"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 authorization. This new drug permission for restricted emergency use is now in operation," Vinod K. Paul, member (health) of NITI Aayog and chairman of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), said at a press conference.

DCGI has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules 2019 under Drugs and Cosmetics Act 1940.

"Today it's important for us to say a regulatory step has been taken. This opens pathways for import. Let's wait and see how this opportunity will be used for importing vaccines for our country. No briefing trial will be conducted. We will observe the beneficiaries who will be given these vaccines," said added Dr. Paul.

Moderna's vaccine is said to be 90 per cent effective against COVID-19. It is an mRNA vaccine that has fragments of the genetic material known as messenger RNA. The vaccine works by giving cells temporary instructions to make the coronavirus spike protein. The protein is found on the surface of the COVID-19 virus.

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