Pfizer India has applied to the Drugs Controller General of India (DCGI) for an emergency-use authorisation for its Coronavirus vaccine in India after it’s the parent company, Pfizer, earlier this week was given nod for emergency-use clearance in the UK and Bahrain.
According to sources, in its application, Pfizer has sought permission from the regulator to import the vaccine for sale and distribution in the country and is also seeking for the waiver of clinical trials on Indian population by the special provisions under the New Drugs and Clinical Trials Rules, 2019.
On December 4, Pfizer India had submitted an application to the DCGI seeking emergency use authorization (EUA) for its Covid vaccine in India. The EUA application has been submitted in the Form CT-18 to get permission for the import and market of Pfizer-BioNTech's Covid-19 vaccine in India.
The United Kingdom after approving the Pfizer/BioNTech vaccine against Covid-19 on December 2 became the first country to approve a vaccine use. Temporary authorisation for the emergency use of corona vaccine developed by Pfizer was granted by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA).
On Friday, Bahrain became the second country to approve for the two-dose vaccine use made by Pfizer and its partner German company BioNTech.
Pfizer has said that it is in talks and exploring options to get a nod from the Indian government so that their vaccine is available for use in the country.
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The pharma firm in a statement said, "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.”
Earlier, AIIMS Delhi Director Dr Randeep Guleria had said that India was discussing with Pfizer-BioNTech regarding its coronavirus vaccine candidate.