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Earlier, vaccines that had completed clinical studies outside the country were required to carry out ‘bridging trials’ on Indian people
New Delhi: The Drugs Controller General of India (DCGI) has done away with specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies – a big move likely to clear the way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement.
In a letter, DCGI Chief VG Somani letter said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
“In light of the huge vaccination requirements and the need for increased availability of imported vaccines,… 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 said.
Somani added that for the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval brigding 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/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 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.
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