DCGI exemption is expected to bring foreign vaccines like Pfizer, Moderna: The Tribune India

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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 enormous immunization requirements and the need for increased availability of imported vaccines, (…) EMA, UK MHRA, PMDA Japan or which are listed in the emergency use list of WHO, ”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.

“Review and revision of their batch summary protocol and batch / batch certificate of analysis should be performed by CDL Kasauli for batch release in accordance with standard procedures and the assessment requirement of the first 100 recipients. for 7 days for safety results before the vaccine is rolled out other immunization programs, as well as other procedures for filing claims and timing of claims processing, etc., as outlined in the notice of 04.15.21, will remain the same. Dr Somani said in the letter. ANI



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