New Delhi: Moderna has sought regulatory approval for its COVID-19 vaccine in India. Meanwhile, it is being speculated that the Drugs Controller General of India (DCGI) is likely to approve the American pharmaceutical’s vaccine soon for emergency use in those aged 18 and above.
As per the sources, Mumbai-based Cipla has applied for import and marketing authorisation of Moderna’s covid jabs.
Cipla filed an application on Monday seeking permission for import of Moderna 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 authorization without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
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 has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
