Mumbai-based pharmaceutical firm Cipla has received permission from the Drugs Controller General of India (DCGI) to import Moderna’s COVID-19 vaccine for restricted emergency use in India.
The Mumbai-based pharmaceutical firm Cipla has been granted permission by the Drugs Controller General of India (DCGI) to import Moderna’s COVID-19 vaccine for limited emergency use in India, the Centre announced on Tuesday. After Covishield, Covaxin, and Sputnik, Moderna’s vaccine will be the fourth COVID-19 vaccine available in India.
“Moderna, the first internationally developed vaccine, has received new drug approval. Dr. VK Paul Niti Aayog Member-Health stated that “This new drug authorization is for limited use only.”
Moderna informed DCGI on June 27 that the US government had consented to donate a set number of doses of its COVID-19 vaccine through COVAX to India for use here, and that the vaccines had been approved by the Central Drugs Standard Control Organisation (CDSCO).
“This permission is only to be used in emergency cases where the public’s safety is at risk.
According to the approval order, the company must submit a 7-day safety assessment of the vaccine in the first 100 recipients before rolling out the vaccine for further vaccination “a source confirmed.
Cipla filed an application on Monday seeking permission to import Moderna’s vaccine, citing DCGI notices dated April 15 and June 1, which state that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without a bridging trial and that safety data for the first 100 vaccine recipients must be submitted before the vaccine is rolled out in immunizations.
Furthermore, Moderna has informed the government of India via separate communication that the US government has agreed to donate a certain number of doses of the Moderna vaccine, mRNA-1273, via COVAX to the government of India for use in the country and has submitted the dossiers via e-mail.
On June 1, the DCGI decided to waive batch testing 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 in order to expedite vaccine rollout.
In April, the central government issued detailed guidelines and proactively eased entry into India of foreign-made COVID-19 vaccines approved by the US FDA, EMA, the UK’s MHRA, and Japan’s PMDA, as well as WHO’s Emergency Use Listing.
