The Central Drugs Standard Control Organization (CDSCO) by way of a notification dated 01.06.2021, has issued guidance for approval of Covid-19 vaccines for restricted use in emergency situations. This applies for such vaccines that are already approved for the same by US, FDA, EMA, UK MHRA, PMDA, Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines. The requirement for Post approval bridging clinical trials and testing of every batch can be relaxed if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin.
