Pfizer India has turned out to become the first pharmaceutical firm to seek authorisation from the Drugs Controller General of India (DCGI) for emergency use of its COVID-19 vaccine after it secured clearance in the UK and Bahrain, a PTI report stated.
“In its application submitted to the drug regulator, Pfizer 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 to PTI.
“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 in the PTI report.
Meanwhile, the extremely low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, top government officials have said to the news agency.