India's drug regulator is likely to grant restricted emergency use authorisation for Moderna's Covid-19 vaccine, official sources said on Tuesday.
In a separate communication, Moderna has informed that the US has agreed to donate a certain number of doses of its Covid-19 vaccine through COVAX to the Government of India for use here and has sought approval from the Central Drugs Standard Control Organisation (CDSCO), while Cipla, on behalf of the US pharma major, has requested for import and marketing authorisation of these jabs.
According to the sources, an approval is likely anytime as the CDSCO is in favour of granting permission to Cipla for import of Moderna's Covid-19 vaccine for restricted emergency use in India considering the pandemic situation in the country and in public interest.
Cipla filed an application on Monday seeking permission for import of Moderna's Covid-19 vaccine referring to DCGI notices dated April 15 and June 1 as per which 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 immunisation programme.
Also, the requirement of testing of every batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin.
However, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release as per standard procedures, Cipla said referring to the DCGI's new revised rules.
Moderna through a separate communication has informed that the US Government has agreed to donate a certain number of doses of the Moderna Covid-19 Vaccine, mRNA-1273, through COVAX to the Government of India for use in India and has submitted the dossiers through e-mail.
"This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines," Moderna said.
In a bid to expedite the roll out of vaccines, the DCGI on June 1 decided to waive off 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 Centre had in April issued detailed guidelines and proactively eased entry of foreign made Covid-19 vaccines approved by the 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.