The country will soon get another vaccine of Corona. Today the Drugs Controller General (DCGI) has given permission for import of Moderna’s Covid-19 vaccine for Cipla emergency use. Earlier, the government had approved Russia’s Sputnik V vaccine for emergency use. With this, some four vaccines have been done in the country so far. Moderna’s vaccine will be the fourth Covid-19 vaccine to be available in India after Covishield, Covaxin and Sputnik.
DCGI has permitted Cipla to import Moderna’s Covid-19 vaccine for limited emergency use in the country as per the provisions of the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940. ‘
Moderna informed DCGI in a letter on June 27 that the US government has agreed to donate a specific number of doses of its Covid-19 vaccine, ‘Covax’, to the Indian government for use here. Also, it has sought approval from the Central Drugs Standard Control Organization (CDSCO) for this.
Cipla on Monday requested the drug regulator to grant import and marketing rights to these vaccines on behalf of the American pharma company. It is noteworthy that Covax is a global initiative for equitable distribution of Covid-19 vaccine.
An official said that this permission is in public interest for limited use in emergency situations. The company must submit the vaccine safety assessment in the first 100 beneficiaries before starting to use the vaccine for the vaccination programme.
Cipla had sought permission to import this vaccine by giving an application on Monday. He had referred to the DCGI notices dated April 15 and June 1.
The notice said that if the vaccine is permitted by the US Food and Drug Administration (USFDA) for Emergency Use Rights (EUA), the vaccine can be marketed without a ‘bridging trial’. In addition, each consignment can be exempted from the need to get tested by the Central Drugs Laboratory (CDL), Kasali.