“In order to make vaccines available to the Indian population at the earliest and fulfill need for vaccine imports… 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,” he told ANI.
Somani said that conducting post-approval clinical trials and testing each batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted for the vaccines which are already in use by millions of people worldwide. The specific trials will no longer be in need if the vaccine batch/lot has been certified and released by the National Control Laboratory of the Country of Origin.
Earlier, vaccines that had completed clinical studies outside the country were required to carry out “bridging trials” or limited clinical trials on the Indian population to know how the drug works on people of Indian origin.
“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 (for) further immunization programs, along with other procedures for filing of applications and timeline for processing of the applications, etc, as laid down in the notice dated 15.04.21 shall remain the same.” Dr Somani said in the letter.