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DCGI Waiver Likely to Bring Foreign Vaccines Like Pfizer and Moderna One Step Closer | India News


NEW DELHI: The Comptroller General of Medicines of India (DCGI) has removed specific Covid-19 vaccine trials that have been approved by other international regulatory bodies, a huge move that will likely pave the way for foreign vaccines such as Pfizer and Moderna to the Urgent Requirement of the country.
In a letter, the letter from DCGI director VG Somani said that this will 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 greater availability of imported vaccines, … it has been decided that for the approval of Covid-19 vaccines in India for restricted use in emergency situations that are already approved for use restricted by the US FDA, EMA, UK MHRA, PMDA Japan or listed on the WHO emergency use list, “he said.
Somani added that for vaccines that are well established from the standpoint that millions have already been vaccinated with such vaccines, the requirement to conduct brigding post-approval clinical trials, and the requirement that the Central Drug Laboratory test each batch of the vaccine. (CDL), Kasauli may be exempt, if the vaccine lot / lot has been certified and released by the National Control Laboratory of the Country of Origin.
Previously, vaccines that had completed clinical studies outside the country had to undergo “bridge trials” or limited clinical trials in the Indian population to find out how the drug works in people of Indian origin.
“CDL Kasauli will scrutinize and review its Batch Summary Protocol and Batch / Batch Analysis Certificate for batch release under standard procedures and the first 100 beneficiary assessment requirement for 7 days to the safety results before the vaccine has been put in place more immunization programs, along with other procedures for the submission of applications and the schedule for the processing of applications, etc., as established in the notice dated 15.04 .21 will remain the same. ” Dr. Somani said in the letter.

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