Today PFIZER India has become the first pharma company to seek emergency use authorisation with certain conditions from the Drugs Controller General of India (DCGI) for its Covid-19 immunisation in the nation. This comes subsequent to its parent organization Pfizer-BioNtech that got clearance in the UK and Bahrain.
After Pfizer from UK reported 90% efficacy, it became the first country to get approval for Covid-19 vacccine from the UK regulator Medicines and Healthcare products Regulatory Agency for its emergency use.
In its application to the medication controller, Pfizer-BioNTech has sought for consent to import the vaccine available to be purchased and disseminated in the nation under the New Drugs and Clinical Trials Rules, 2019, as per the firm’s statement. Pfizer India has applied on December 4 to the DCGI urging emergency use authorisation (EUA) for its vaccine in India and awaits the nod.
The pharma firm has submitted the EUA application in Form CT-18 for getting grant to import and market it’s Covid-19 mRNA vaccine BNT162b2 across the nation.
V K Paul, who spearheads the top notch National Expert Group on Vaccine Administration, had earlier strategically asserted that nation realised to make its own vaccine considering the dire requirement.