New Delhi: Pfizer India has become the first pharmaceutical firm to approach the Drugs Controller General of India (DCGI) seeking an emergency use authorisation for its Covid-19 vaccine in the country.
It is to be noted that Pfizer India’s parent company Pfizer has already got emergency-use clearance in the United Kingdom and Bahrain. According to an official source, “Pfizer India has sought permission for emergency usage authorisation of its Covid-19 from DGCI to import and market.”
The application was submitted by Pfizer India on 4 December to the DCGI seeking emergency use authorisation (EUA) for its vaccine in India.
Pfizer India has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s Covid-19 vaccine in India.
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.
On 2 December, the UK became the first country to approve the Pfizer/BioNTech coronavirus vaccine. The UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) has granted a temporary authorisation for the emergency use of coronavirus vaccine developed by Pfizer. Bahrain on Friday also granted permission for the two-dose vaccine made by Pfizer and its German partner BioNTech.
At an all-party meeting recently, Prime Minister Narendra Modi said a Covid-19 vaccine is expected to be ready in the next few weeks, and as soon as scientists give a green signal, vaccination will start in India.