October 18, 2021

DCGI waiver will bring foreign Covid-19 vaccines of Pfizer, Moderna one step closer

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The Drugs Controller General of India (DCGI) has declared that clinical trials in the country for the foreign Covid-19 vaccines which have already been approved by other international agencies, which is a big move to clear the foreign vaccines like Pfizer, and Moderna for the urgent requirement as the country is having shortage of the vaccines.

In a letter, DCGI, Dr VG Somani said the same will be applicable for vaccines priorly approved for emergency authorization use by US FDA, EMA, UK MHRA, PMDA Japan or listed by the World Health Organization (WHO).

Somani said, “In light of the huge vaccination requirements and the need for increased availability of imported vaccines… It has been decided that for approval of COVID-19 vaccines in India for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing.”

Somani added for the well-established vaccines from the standpoint that millions have been given the same vaccine, which is the requirement for initiating post-approval bridging clinical trials and the requirement of testing of every consignment of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be considered as an exception, when the vaccine lot has been certified and released by the National Control Laboratory of the Country of Origin.

Somani further added, “The scrutiny and review of their Summary Lot Protocol and Certificate of the Analysis of Batch/Lot shall be undertaken by CDL Kasauli for batch release as per standard procedures and the requirement of assessment of the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out further immnization programmes, along with other procedures for filing of applications and timeline for processing of the applications, etc, as laid down in the notice dated 15.04.2021 shall remain the same.”

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