The Drugs Controller General of India (DCGI) granted permission to Cipla to import Moderna’s Covid-19 vaccine for restricted emergency use in the country, sources told PTI.
Moderna’s vaccine will become the fourth COVID-19 vaccine to be used in India’s inoculation programme.
“Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under Drugs and Cosmetics Act, 1940,” a source told PTI.
The development comes in the backdrop of Moderna seeking approval from DCGI for its vaccines to be used in India after the US government agreed to donate a few of its doses through COVAX to India.
Cipla, on behalf of Moderna, had applied to DCGI for import and marketing authorisation of the COVID-19 vaccine.
“This permission is for restricted use in emergency situations in public interest. The firm has to submit seven days safety assessment of the vaccine in the first 100 beneficiaries before rolling out of the vaccine for further immunisation programme, according to the approval order,” an official said.
On Monday, Cipla had applied for permission to import 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.
Also, 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 the 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, Cipla said referring to the DCGI’s revised rules.
On June 1, in a bid to expedite the rollout of vaccines, the DCGI 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.
(Edits by EP News Bureau)