Pfizer India becomes the first pharmaceutical firm to seek from the Drugs and Controller General of India (DCGI)an emergency use authorisation for its Covid-19 vaccine in the country.
The application was sought after its parent company secured a clearance in UK and Bahrain.
On 4th December, the firm has submitted the Emergency Use Authorisation (EUA) application to the drug regulator for grant of permission to import, sale and distribute the Pfizer-BioNTech’s COVID-19 vaccine in the country. Additionally, it also seeks to wavier of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
The firm has also stated that it would remain committed to engaging with the Government of India to make this vaccine available for use in the country. It further stated that Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval.