Cipla, a multinational pharmaceutical company headquartered in Mumbai, on Tuesday received approval from the Drugs Controller General of India (DCGI) to import Moderna’s coronavirus vaccine for emergency use in India. Moderna’s Covid-19 vaccine will be the 4th vaccine to be regulated in India after Bharat Biotech Covaxin, SII’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 given to people above 18 years of age. Children below 18 years are yet to be covered under the vaccination program. Cipla filed the application after the DCGI notices on April 15 and June 1 allowed marketing authorization without bridging trials and assessment of safety data of the first 100 beneficiaries to vaccine manufacturers that were 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.