DCGI Exempts Bridging Trials And Batch Testing For Imported Covid-19 Vaccines

Mumbai : The Drugs Controller General of India (DCGI) has exempted the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli if the vaccine batch or lot has been certified and released by National Control Laboratory of Country of Origin.

This is with reference to the already approved Covid-19 vaccines for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO emergency use listing.

This has been done in light of huge vaccination requirements in India and in the wake of the recent surge of Covid-19 cases.

This move will cater to the demand for imported vaccines to meet the national requirements even though the domestic manufacturing of Covid-19 vaccines is getting augmented.

As per a DCGI notice, “In partial modification of this office notice of even number dated April 15, 2021 as per the recommendation of National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), it has been decided that the approval of Covid-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch or lot has been certified and released by National Control Laboratory of Country of Origin.”

“However, scrutiny and review of their summary lot protocol and certificate of analysis of batch or lot shall be undertaken by CDL Kasauli for batch releases as per the standard procedures and the requirement of assessment on the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out for further immunization programme along with other procedures for filing of applications and timelines for processing of the applications etc as laid down in the notice dated April 15, 2021 shall remain the same,” the DCGI notice further stated.

Covid vaccine approval 1 June and 15 April, 2021-030621083937

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