Bhubaneswar:US Pharma major Pfizer has withdrawn its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.
Pfizer was the first pharmaceutical company to apply for emergency use authorization from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country, after it secured clearance in the UK and Bahrain.
“In pursuance of the EUA of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 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.
However, it will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement added.
In its application submitted to the drug regulator in December 2020, Pfizer had sought permission to import the vaccine for sale and distribution in India, 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 had said.