2 Requirements Done Away With for COVID Vaccine Approval in India

“In light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 and the need for increased availability of imported vaccines to meet the national requirements even though the domestic manufacturing of COVID-19 vaccines is getting augmented… it has been decided that for 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 every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin [sic],” the notice read.

“However, scrutiny and review of their Summary Lot Protocol & Certificate of analysis of Batch/Lot shall be undertaken by CDL Kasauli for Batch release 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 immunisation programme. along with other procedures for filing of applications and timelines for processing of the applications, etc… shall remain the same,” it added.

Crime Today News | INDIA



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