|  |  | 

India Top Headlines

Pfizer Becomes First Indian Pharmaceutical Company to Apply for Emergency Use Clearance for its Covid-19 Vaccine | India News


NEW DELHI – Pfizer India has become the first pharmaceutical company to approach the Comptroller General of Medicines of India (DCGI) seeking an emergency use authorization for its Covid-19 vaccine in the country.
It should be noted that Pfizer India’s parent company, Pfizer, has already obtained authorization for emergency use in the UK and Bahrain.
According to an official source, “Pfizer India has requested permission for the emergency use authorization of its Covid-19 from DGCI to import and trade.”
The application was submitted by Pfizer India on December 4 to DCGI seeking emergency use authorization (US) for its vaccine in India.
Pfizer India has submitted the US application on Form CT-18 for the granting of permission to import and market the Covid-19 vaccine from Pfizer-BioNTech in India.
The extremely low temperature of minus 70 degrees Celsius, required to store the vaccine, poses a great challenge for delivery in a country like India.
On December 2, the UK became the first country to approve the Pfizer / BioNTech coronavirus vaccine. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for the emergency use of the coronavirus vaccine developed by Pfizer.
Bahrain also granted permission for the two-dose vaccine made by Pfizer and its German partner BioNTech on Friday.
At an all-party gathering recently, Prime Minister Narendra Modi said that 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 begin in India. Meanwhile, India recorded 36,011. new Covid-19 infections in the last 24 hours, the Union Ministry of Health and Family Welfare said on Sunday.
Total Covid-19 cases in India reached 96,44,222, including 4,03,248 active cases and 91,00,792 recoveries. With 482 new deaths, the cumulative number rose to 1,40,182.

Reference page