New Delhi: Pfizer India has become the first pharmaceutical firm to seek emergency use authorisation for its COVID-19 vaccine candidate in the country.
The company has sought permission from the Drugs Controller General of India (DCGI) 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, officials said.
The Pfizer application came after its parent company secured such clearance in the UK and Bahrain. For the vaccine to be considered for use here, the Indian subsidiary of Pfizer will have to share the data it has submitted to the UK regulator with DGCI, The Indian Express reported.
“Pfizer India submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine,” 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 official added, citing the application.
VK Paul, who heads the National Expert Group on Vaccine Administration, had earlier spelled out India’s strategy with respect to candidates like Pfizer and Moderna which have shown positive results in Phase III abroad, but are not being tested here.
“We know that doses of this vaccine (Pfizer) will not be available in huge quantities… If this vaccine candidate has to come, and if we require it, we are preparing ourselves… we have parallel plans,” Paul had said.
