New Delhi, December 6
With Pfizer India this week becoming the first pharma firm to seek “emergency use authorisation” (EUA) for its Covid-19 vaccine in India, all eyes are on the national drug regulator to see if he permits the request considering the firm wants the need for domestic clinical trials waived.
Officials in the Central Drug Standards Control Organisation said Pfizer India had submitted the EUA application for permission to import and market Pfizer-BioNTech’s Covid-19 mRNA vaccine BNT162b2 in the country and a waiver for clinical trials on Indians under the provisions of the New Drugs and Clinical Trials Rules, 2019.
The application to Drug Controller General of India VG Somani comes after Pfizer got similar approvals in the UK and Bahrain.
Somani said, “So far as vaccines developed outside India go, pre-clinical and clinical data generated outside the country is considered for approvals along with the bridging trial data in India. For trials in India, we have adopted accelerated rolling reviews of multiple phases at the same time. Interim analysis of clinical trial data at predefined stages is also permitted to facilitate early decisions in an emergency situation.” — TNS