Cipla gets DCGI approval to import Moderna vaccine for emergency use in India
text_fields
Cipla, a multinational pharmaceutical company headquartered in Mumbai, has sought Drugs Controller General of India nod for importing Moderna's coronavirus vaccine, sources told PTI.
According to sources, Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940.
Following reports that the pharma major had filed an application with the DCGI for permission to import Moderna's COVID-19 vaccine, Cipla's share price touched a 52-week high of Rs 988.80, gaining 2.5 percent intraday on Tuesday.
An official from Cipla told PTI that the permission for restricted use in emergency situations was in public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order.
The update comes after earlier in the day reports suggested that India's drug regulator may soon grant restricted emergency use authorisation for Moderna's vaccine and an approval is likely anytime as the Central Drugs Standard Control Organisation (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 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.
News reports also suggested that US pharma company Moderna is 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 a certain number of 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.
Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik.
