Pfizer seeks DCGI for emergency approval of COVID-19 vaccine in India
New Delhi, Dec 06: Pfizer India has become the first pharmaceutical firm has sought from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine.
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 Dec. 4, the report said.
The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use.