New Delhi: The Drugs Controller General of India on Tuesday gave its regulatory approval for the import of COVID-19 vaccine for restricted emergency use in India, PTI sources confirmed.
According to ANI, Cipla and Moderna have got a DCGI nod for the import of the COVID-19 vaccine, and the Government of India will soon make an announcement, as per agency sources. Mumbai-based pharmaceutical firm Cipla, on behalf of the US pharma major, had previously requested for import and marketing authorisation of these jabs.
India’s drug regulator DCGI has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
“Drugs Controller General of India (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,” a source told PTI.
“New drug permission has been granted to Moderna, the first internationally developed vaccine. This new drug permission is for restricted use,” Dr. VK Paul, Member-Health, Niti Aayog said on Tuesday.
Moderna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COVAX to the Government of India for use and had also sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
Cipla filed an application on Monday seeking permission for import of Moderna COVID-19 vaccine referring to Drugs Controller General of India (DCGI) notices dated April 15 and June 1 stating that if the vaccine is approved by the USFDA for EUA.
The authorisation will make Moderna’s injections, the fourth COVID-19 vaccine in India after Bharat Biotech’s Covaxin, SII’s Covishield, and Gamaleya’s Sputnik-V. While the former two have been administered since January 16, 2021, when India began its national immunization programme against Covid-19, Sputnik has been rolled out recently at Delhi hospital.
The authorisation took precedence due to rising cases of highly virulent Delta and Delta plus variant of Coronavirus mutation in the country. Some studies have pointed out the Sputnik is highly effective against the Delta variant while the AIIMS chief on Monday added that there is not enough scientific data to support the argument on the efficacy of Covid vaccines against the Delta plus variant.
On June 1, in a bid to expedite the rollout of vaccines, the DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK’s MHRA or the WHO.
The central government in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India.
According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.
The World Health Organisation gave a go-ahead for emergency use of Moderna’s COVID-19 vaccine on May 1, 2021.
(With inputs from PTI and ANI)