Advertisment

DCGI waiver likely to bring foreign COVID-19 vaccines like Pfizer, Moderna

author-image
Rajan Nath
New Update
DCGI waiver likely to bring foreign COVID-19 vaccines like Pfizer, Moderna
Advertisment
The Drugs Controller General of India (DCGI) has done away with specific trials of Covid-19 vaccines approved by other international regulatory bodies. With this, it will clear the way for foreign vaccines like Pfizer and Moderna to India. The DCGI Chief VG Somani letter said that it will be applicable for COVID-19 vaccines that have already been approved for restricted use by the international regulatory bodies like US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
Advertisment
Also Read | Coronavirus India Updates: Myths and Facts of COVID-19 vaccination; here is what PM Modi govt doing to vaccinate Indians Pfizer and Moderna in India soon: DCGI done away with specific trials of Covid-19 vaccines approved by other international regulatory bodies. "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 Vaccines in India for restricted use in an emergency situation which is already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing," Somani said in a letter. Also Read | Third wave of coronavirus in Maharashtra? Over 8,000 children test positive in 1 district
Advertisment
Pfizer and Moderna in India soon: DCGI done away with specific trials of Covid-19 vaccines approved by other international regulatory bodies. Earlier, vaccines that had completed the clinical trials outside the country were required to carry out "bridging trials" or limited clinical trials on the Indian population. This was to find out how the drug works on Indians. Pfizer and Moderna in India soon: DCGI done away with specific trials of Covid-19 vaccines approved by other international regulatory bodies. "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 immunisation programmes, along with other procedures for the 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 added in the letter. Now, this will likely bring more foreign vaccines to India like Pfizer and Moderna. Pfizer spokesperson said that it continues to remain engaged with the Government of India towards making its COVID-19 vaccine available for use in the immunization program in the country. Click here to follow PTC News on Twitter -PTC News-
pfizer moderna covid-19-vaccines pfizer-moderna pfizer-moderna-india
Advertisment

Stay updated with the latest news headlines.

Follow us:
Advertisment