Pfizer India has become the first pharma company to approach the Drugs Controller General of India (DGCI) to seek an emergency use authorisation of its vaccine for COVID-19 in India.
As per the official source, Pfizer India has asked for permission for emergency use authorisation of the vaccine from DGCI to import and market. The company had submitted the application on December 4.
The request by Pfizer is also the first one that has been received by DGCI amid the race of finding the vaccine for the deadly virus. It must be noted that Pfizer, the parent company of Pfizer India, has already got an emergency use authorisation for its vaccine in the United Kingdom and Bahrain.
Pfizer seeks emergency approval in India:
In the application submitted on December 4, 2020, Pfizer has asked for permission to import the vaccine for sale as well as for distribution in India, besides waiving off clinical trials on Indian citizens in accordance with the special provisions that are under the New Drugs and Clinical Trials Rules, 2019.
The C-18 application of Pfizer for the grant of permission to import the new coronavirus vaccine for sale in India is in process and the application has to be decided within 90 days as per the New Drugs and Clinical Trials Rules 2019.
However, the drug regulator will only give emergency approval if it is satisfied with the results of clinical trials that are conducted outside India.
As per the official, The Drugs Controller General of India has discretionary power for waiving off the localised clinical trials for a vaccine but to date, such power has not been used.
COVID vaccine status in India:
Prime Minister Modi, in an an-all party meeting, had informed that the vaccine for the deadly virus is expected to be ready in the next few weeks. He added that as soon as the scientists will give a green signal to the vaccine, vaccination will be started in India.
In the case of Pfizer vaccine storage, the extremely low temperature which is required for storing the vaccine is minus 70 degrees Celsius. It poses a big challenge for vaccine storage and delivery in India.
Pfizer approved in UK and Bahrain:
On December 2, 2020, the United Kingdom had become the first country to approve Pfizer/BioNtech COVID-19 vaccine. The emergency use of authorization was given by the country’s regulator Medicines and Healthcare Products Regulatory Emergency (MHRA) for the vaccine developed by Pfizer.
On December 4, Bahrain also granted permission for the use of a vaccine that has been developed by Pfizer and its German partner BioNTech.
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