New Delhi: In an effort to intensify the vaccine drive in the country, the Drugs Controller General of India (DCGI) on Tuesday granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country. With this, Moderna’s vaccine will be the fourth COVID-19 vaccine to be available in India after Covishield, Covaxin and Sputnik.Also Read - Govt Panel Recommends Emergency Approval of Serum Institute's Covovax For 7-11 Year-Olds
Official sources told news agency PTI that the DCGI has granted permission as per the provisions of the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940. Also Read - COVID Symptoms? Follow These Measures Immediately For Quick Recovery And Help Others From Getting Infected
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- On June 27, Moderna had informed the 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 and sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.
- Moreover, Cipla had on Monday on behalf of the US pharma major requested the drug regulator for import and marketing authorisation of these jabs.
- Cipla had also filed the application seeking permission for import of Moderna’s vaccine referring to DCGI notices dated April 15 and June 1 according to which if the vaccine is approved by the USFDA for EUA, the vaccine 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 in immunisation programme.
- As per latest updates, the permission is for restricted use in emergency situations in public interest and 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.
- The Cipla said that the requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin, however summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures.
- In a separate communication, Moderna had earlier informed that the US government has agreed to donate a certain number of doses of the Moderna vaccine, mRNA-1273, through COVAX to the government of India for use in the country and has submitted the dossiers through e-mail.
- The DCGI had on June 1 decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK’s MHRA or the WHO.
- The Centre had in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India.