Pfizer remains committed to making its vaccine available in India, a company spokesman said
New Delhi:
Pharma Major Pfizer said Friday it has decided to withdraw its application for Emergency Use Authorization (EUA) of its COVID-19 vaccine in India.
Pfizer was the first pharmaceutical company to seek an emergency use clearance from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country, after obtaining such approval in the UK and Bahrain.
As part of the Emergency Use Authorization of its COVID-19 vaccine, Pfizer participated in the meeting of the Subject Expert Committee of the Drug Regulatory Authority of India on Feb. 3. Based on the deliberations at the meeting and our understanding Of additional information that the regulator may need, the company has decided to withdraw its application at this time, ” a company spokesperson said in a statement.
Pfizer will continue to liaise with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.
“Pfizer remains committed to making its vaccine available for government use in India and to follow the required emergency use authorization pathway that will enable the availability of this vaccine for future applications,” said the spokesman.
In its application to the drug regulator in December 2020, Pfizer had requested permission to import the vaccine for sale and distribution in India, in addition to refraining from clinical trials on the Indian population in accordance with the special provisions of the New Drugs and Clinical Trials Rules , 2019, official sources had told PTI.
(Except for the headline, this story has not been edited by NDTV personnel and has been published from a syndicated feed.)