Cipla gets DCGI nod to import Moderna COVID-19 vaccine

Cipla gets DCGI nod to import Moderna COVID-19 vaccine

Cipla has been given approval for emergency use in the country

Cipla has been given the approval by the Drugs Controller General of India (DCGI) to import Moderna's COVID-19 vaccine for restricted emergency use in the country. Moderna’s COVID-19 vaccine will be the fourth vaccine to be administered to Indians after Bharat Biotech's Covaxin, Serum’s Covishield and Russian vaccine Sputnik V. The pharma company had filed an application on Monday seeking the regulator’s nod to import the Moderna vaccine to India.

The vaccine will be administered to beneficiaries above 18 years of age. Children below 18 years are yet to be covered under the vaccination programme.

Cipla filed the application after the DCGI notices on April 15 and June 1 allowed marketing authorisation without bridging trials and assessment of safety data of the first 100 beneficiaries to vaccine manufacturers that was approved by the US FDA for emergency use.

Moreover, the US government has also agreed to donate a portion of Moderna vaccines to the Indian government through COVAX. The company had sought approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccine.

Vaccine manufacturers like Moderna and Pfizer had sought legal indemnity in India to exempt themselves from adverse effects suffered by beneficiaries after the dosage.

Also read: Cipla may import Moderna’s COVID-19 vaccine; approval likely today