By: Pramod Thomas
INDIA’s Cipla Ltd has been granted new drug permission for restricted use of Moderna Inc’s Covid-19 vaccine in the country, a senior government official said on Tuesday (29).
It is the first internationally-developed vaccine and the fourth such jab to be approved in the country after Covaxin, Covishield and SputnikV.
“New drug permission has been granted to Moderna, the first internationally developed vaccine. This new drug permission is for restricted use,” said Dr VK Paul, Member-Health, Niti Aayog.
“There are four vaccines now Covaxin, Covishield, SputnikV and Moderna. We will soon close the deal on Pfizer as well.”
In separate communications, Moderna on June 27 informed 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 here and sought approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.
Mumbai-based pharmaceutical company Cipla had filed an application seeking permission for import of Moderna’s Covid-19 vaccine referring to DCGI notices dated April 15 and June 1 as per 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 immunization programme.
Also, the requirement of testing of every batch by the 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 as per standard procedures, Cipla said referring to the DCGI’s new revised rules.
In a bid to expedite the rollout of vaccines, the DCGI on June 1 decided to waive off 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 the entry of foreign-made Covid-19 vaccines approved by the US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India.
According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.
