Pfizer India has sought permission from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country.
The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources said.
“Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India,” a source said.
The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s COVID-19 mRNA vaccine BNT162b2 in the country,” the source said, citing the application.
During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the global pharma major said in a statement.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.
Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine.
