Cipla, a Mumbai-based pharmaceutical company, on Tuesday was granted Drugs Controller General of India (DCGI) approval to import Moderna’s Covid-19 vaccine for restricted emergency use in India.
“New drug permission has been granted to Moderna, the first internationally developed vaccine. This new drug permission is for restricted use,” said Dr VK Paul, Member-Health, Niti Aayog.
Moderna had earlier sought regulatory approval for its Covid-19 vaccine in India.
“There are four vaccines now Covaxin, Covishield, SputnikV and Moderna. We will soon close the deal on Pfizer as well,” Paul added.
Moderna has further informed that the United States government has agreed to donate a certain number of its vaccine doses through the global initiative of COVAX to India and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for the same.
Mumbai-based pharmaceutical company Cipla, on behalf of the US vaccine maker, had applied for the import and marketing authorisation of the jabs.
Cipla had on Monday filed an application seeking permission to import Moderna’s Covid-19 vaccine referring to DCGI notices dated April 15 and June 1 stating that “if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme”.
Reports earlier claimed that the Centre had agreed to purchase vaccines from Moderna and Pfizer only if they are offered at a special price.
Earlier this month, sources in the Union Health Ministry revealed that the central government is likely to provide indemnity against legal proceedings to the foreign coronavirus vaccine manufacturers along the lines of the permission granted by some countries.
