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COVID-19: Serum Institute applies for market authorisation of Covishield, SEC to review today

05:00 PM Nov 24, 2021 | FPJ Web Desk

The Serum Institute of India on Wednesday submitted an application for ‘market authorisation’ of Covishield to the subject expert committee (SEC) of the Drugs Controller General of India (DCGI). According to a report, the committee will meet today to discuss the company’s submission.

A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions.

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Currently, Covishield is being administered in India in emergency-use authorisation mode. The vaccine was approved on January 4, 2021, in EUA and has been administered to over 104 crore people so far in the country.

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The Indian government has also exported the vaccine to neighbouring countries, including Bangladesh, Nepal and Myanmar.

EUA only authorises the use of an unapproved product or unapproved use of an approved product in a declared state of emergency such as a pandemic. It does not represent approval of a vaccine in the full statutory term.

Nepal and India yesterday agreed to recognise Covid-19 vaccine certification. A Memorandum of Understanding (MoU) was signed in this regard by India's Ambassador to Nepal Vinay Mohan Kwatra and the Himalayan nation's Health Secretary Roshan Pokharel during a function here.

Nepal has been using the India-made Covishield, China's Vero Cell and three other American vaccines to inoculate its population against Covid-19. People who have been fully vaccinated can now travel in the two nations after showing the vaccine certificate, according to Nepal's Ministry of Health and Population.

This MoU is a significant step in easing travel for fully vaccinated travellers of both countries and marks another milestone in robust Covid-19 related cooperation and coordination between New Delhi and Kathmandu, a statement issued by the Indian Embassy in Kathmandu said.

Also Read: Serum Institute of India (SII) gets nod to export 50 lakh doses of COVID-19 vaccine Covishield to COVAX

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