Mumbai-based pharma company Cipla has got the approval of the Drugs Controller General of India (DCGI) to import US pharma giant Moderna’s Covid-19 vaccine for restricted emergency use in India, according to a report by PTI news agency.
In accordance with the new rules, which have been eased to facilitate the import of vaccines to fight the pandemic, Cipla will have to submit a 7-day safety assessment report of the vaccine in the first 100 recipients before rolling out the vaccine for wider use in the inoculation programme.
Cipla had filed an application on Monday seeking permission for the import of Moderna COVID-19 vaccine referring to Drugs Controller General of India (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.
According to media reports, Moderna is also seeking regulatory approval for its Covid-19 vaccine and India's drug regulator may soon grant restricted emergency use authorisation.
In separate communications, Moderna on June 27 informed DCGI that the US government has agreed to donate some doses of its COVID-19 vaccine through COVAX to India for use here and sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.
The Moderna vaccine has to be stored at -70 degrees Celsius and is, therefore, not expected to be made available for mass use as is thecase with India-made vaccines such as Covishield and Covaxin which can be stored at ordinary refrigeration temperatures of 2 to 8 degrees Celsius.
The two vaccines are currently the mainstay of India’s vaccination campaign with Russia’s Sputnik V being the third to have got approval but as yet is being used in small quantities. However, production of the vaccine is expected to pick up as collaborations with six Indian companies are in place to produce 850 million doses a year.