Mumbai-based pharmaceutical multinational Cipla on Tuesday received approval from the country’s drugs regulator to import the COVID-19 vaccine developed by US pharma major Moderna Inc. for restricted emergency use. This will be the fourth vaccine for India.
Niti Aayog member (Health) VK Paul said new drug permission for restricted use has been granted for Moderna’s vaccine which gives a clear possibility of this vaccine being imported into India.
The company had sought Drugs Controller General of India (DCGI) nod for importing Moderna’s coronavirus vaccine.
Cipla filed an application on June 28 seeking permission to import the Moderna vaccine, referring to DCGI notices dated April 15 and June 1 stating that if a vaccine is approved by the USFDA for EUA, it can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out an immunisation programme.
Moderna has also informed that the US government has agreed to donate to India a certain number of doses of the Moderna vaccine through COVAX and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
Moderna’s method to protect against Covid-19 relies on messenger RNA (mRNA) to program cells to generate immunity to the coronavirus.
Several foreign vaccine makers such as Pfizer and Moderna have demanded an indemnity bond that will exempt them from legal claims in case there are any adverse effects from the vaccines when administered in India.