Pfizer India has applied to India’s drug regulator for emergency-use authorisation for its Covid-19 vaccine, after the company’s parent received clearance for the treatment from Britain and Bahrain, Press Trust of India reported.
The company sought permission to import the vaccine for sale and distribution in India without the requirement for clinical trials on local people, in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, the news agency said, citing an unidentified official.
Pfizer is the first drugmaker to seek the approval in India and submitted the application on December 4, the report said
Britain last week became the first country to approve the Pfizer and BioNTech vaccine, when its regulator gave permission for it to be used in emergencies.