DCGI exemption is expected to bring foreign vaccines like Pfizer, Moderna: The Tribune India
New Delhi, June 2
India’s Comptroller General of Medicines (DCGI) has removed specific Covid vaccine trials that have been approved by other international regulatory bodies – a big step that could pave the way for foreign vaccines like Pfizer and Moderna for the urgent needs of the country.
In a letter, the letter from DCGI Chief VG Somani said this would apply to 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 Organization.
“In light of the huge vaccination requirements and the need for increased availability of imported vaccines,… it was decided that for the approval of Covid vaccines in India for restricted use in emergency situations which are already approved for use restricted by the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in the WHO emergency use list, ”he said.
Somani added that for vaccines which are well established from the point of view that millions of people have already been vaccinated with said vaccines, the requirement to conduct post-approval bridging clinical trials and the requirement to test every batch of vaccine by the Central Drugs Laboratory (CDL), Kasauli, may be exempted, if the vaccine lot / lot has been certified and released by the National Control Laboratory in the country of origin.
Previously, vaccines that had completed clinical studies outside the country had to perform “bridging trials” or limited clinical trials on the Indian population to find out how the drug works in people of Indian descent.
“Careful review and revision of their summary batch protocol and batch / batch certificate of analysis should be undertaken by CDL Kasauli for batch release in accordance with standard procedures and the first 100 assessment requirement. recipients for 7 days for safety results before the vaccine is rolled out from other immunization programs, as well as other procedures for filing claims and timing of claims processing, etc., as outlined in the notice dated 15.04.21, will remain the same. Dr Somani said in the letter. ANI