The Drug Controller General of India (DCGI) may approve Cipla’s application to import Moderna COVID-19 vaccine. Decision on the approval is expected today.
The pharma company had reportedly filed an application with DCGI seeking approval to import the vaccine on June 28.
Moderna has informed that the US government has agreed to donate a portion of its COVID-19 vaccine doses through COVAX for the Indian government’s use and has sought the approval from the Central Drugs Standard Control Organisation (CDSCO).
Cipla filed the application referred to DCGI notices dated April 15 and June 1 that said that if a vaccine is approved by the USFDA emergency use authorisation, then the vaccine can be granted marketing authorisation without bridging trials and assessment of safety data of the first 100 beneficiaries.
If approved, the vaccine will be administered to those above 18 years under the vaccination drive.
Meanwhile, vaccine makers such as Pfizer and Moderna have demanded legal indemnity in India to exempt them from any adverse effects after doses are administered.
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