Pfizer remains committed to making its vaccine available in India, a company spokesman said.
New Delhi:
Pharma major Pfizer said on Friday that it had decided to withdraw its application for emergency use authorization (USA) of its COVID-19 vaccine in India.
Pfizer was the first pharmaceutical company to seek an emergency use authorization from the General Drug Controller of India (DCGI) for its COVID-19 vaccine in the country, after obtaining such authorization in the United Kingdom and Bahrain.
“In pursuit of the Emergency Use Authorization for its COVID-19 vaccine, Pfizer attended the meeting of the Indian Medicines Regulatory Authority’s Subject Matters Committee on February 3. Based on the meeting’s deliberations and our understanding of information additional information that the regulator may need, the company has decided to withdraw its order at this point, “a company spokesman said in a statement.
Pfizer will continue to engage with the authority and will resubmit your application for approval with additional information as it becomes available in the near future, the statement said.
“Pfizer remains committed to making its vaccine available for use by the government of India and to seeking the necessary pathway for emergency use authorization that would allow the availability of this vaccine for any future implantation,” said the spokesman.
Pfizer, in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, in addition to dispensing with clinical trials in the Indian population under the special provisions of the New Drug Rules and Clinical Trials, 2019, official sources told PTI.
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