Pfizer seeks from DCGI to import COVID-19 vaccine for sale and distribution across India

After successful clearance in UK and Bahrain, Pfizer is now keen for an emergency use authorization (EUA) for the COVID-19 vaccine in India. In its application to the Drugs Controller General of India (DCGI), the pharm company has sought permission to import the vaccine for sale and distribution across the country.

A source said Pfizer India has submitted an application in Form CT-18 on December 4 to the regulator seeking EUA for its COVID-19 vaccine in India. And it became the first pharma company in India to do so. On Wednesday, the United Kingdom became the first country to approve Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorization for its emergency use. Then on Friday, Bahrain announced that it has given EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. Moreover, the company has also applied for the same with the US FDA.

However, top government officials said the extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult.

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Pfizer India, in a statement, said the company will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval. It said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use.

According to the company’s official portal, Pfizer expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. It is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. As such, the companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of minus 70 degrees Celsius.