Moderna vaccine likely to get DCGI’s nod soon, Cipla applies for import

The Drugs Controller General of India (DCGI) is likely to approve America’s Moderna’s Covid-19 vaccine soon for emergency use on those aged 18 and above, PTI reported on Tuesday.

The news agency reported that pharmaceutical company Cipla has applied for the import and marketing authorisation of the Moderna jabs, once its has regulatory approval.

Moderna has also informed that the US government would be donating a certain number of doses to India through COVAX, a programme by GAVI and WHO to ensure equitable distribution of Covid-19 vaccines globally, for which it has sought approval from the Central Drugs Standard Control Organisation (CDSCO).

The approval is likely to come soon as CDSCO is in favour of doing so, PTI reported.

Cipla filed an application seeking permission for import of Moderna Covid-19 vaccine on Monday. It referred to DCGI notices dated April 15 and June 1, which state that if the vaccine is approved by the USFDA for Emergency Use Approval (EUA), the vaccine can be granted marketing authorization without a bridging trial and the assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in the immunization programme.

Earlier in May, Cipla had requested the government for indemnification and exemptions from price capping, bridging trials and basic customs duty, while stating that it is close to committing over USD 1-billion as advance to the US major Moderna’s single dose vaccine.

Meanwhile, Pfizer CEO Albert Bourla said on June 22 that the Pfizer Covid vaccine is now in final stages to get approval for use in India. ‘I hope very soon we will finalize an agreement with the government,’ he said, news agency ANI reported.

India has scrapped local trials for “well-established” foreign coronavirus vaccines in order to accelerate the vaccination drive in the country.