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Pfizer seeks India nod for Covid vaccine
Pfizer seeks India nod for Covid vaccine
In good news for millions of Indians, Pfizer India has submitted an application to the Drugs Controller General of India (DCGI) seeking an emergency-use authorisation for its Covid-19 vaccine in the country
New Delhi: In good news for millions of Indians, Pfizer India has submitted an application to 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 UK and Bahrain.
Pfizer India, in its application submitted to the DGCI, has sought permission from the regulator to import the vaccine for sale and distribution in the country, sources said, adding that the pharma giant has also sought the waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
The application was submitted by Pfizer India on December 4 to the DCGI seeking emergency use authorization (EUA) for its Covid-19 vaccine in India. It is learnt that 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.
On Wednesday (December 2), the UK became the first country to approve the Pfizer/BioNTech vaccine against Covid-19. 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.
Following into the UK's footsteps, Bahrain on Friday also granted permission for the two-dose vaccine made by Pfizer and its German partner BioNTech. For its part, Pfizer has said it remains committed to engaging with Indian government in order to explore opportunities to make its vaccine available for use in the country.
"During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the global pharma major said.
There are five vaccines in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-AstraZeneca vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial. Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously developed anti-coronavirus vaccine.
Dr Reddy's Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate.
