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Norms for clearing foreign-made COVID-19 vaccines eased

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To ease the supply of imported COVID vaccines, the Drug Controller General of India (DCGI) on Tuesday waived the requirement of conducting bridging clinical trials and testing of every batch of vaccine by the Central Drugs Laboratory (CDL), Kasauli for foreign-made vaccines.

The DCGI said it has been decided that for approval for restricted use in emergency situations which are already approved for restricted use by the U.S. Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, U.K., Pharmaceuticals and Medical Devices Agency, Japan, or which are listed in WHO Emergency Use Listing and which are well established vaccines from the standpoint that millions of individuals have already been vaccinated with them, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the batch/lot has been certified and released by the National Control Laboratory of the country of origin.