December 8, 2021

Serum Institute of India Seeks Regular Marketing Authorization From DCGI For Covishield . Serum Institute of India seeks approval from DCGI for regular marketing of Covishield


Serum Institute of India seeks DCGI approval for regular marketing of Covishield - India TV
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Serum Institute of India seeks approval from DCGI for regular marketing of Covishield

New Delhi: The Serum Institute of India (SII) on Monday sought approval for the regular marketing of its anti-Covid vaccine, noting the supply of more than 100 crore doses of ‘Kovshield’ in India and other countries, which is currently available in the country. Emergency use permitted. Official sources gave this information. Prakash Kumar Singh, director of government and regulatory affairs at SII, has sent an application to the Drug Controller General of India (DCGI) for approval for routine marketing of the vaccine, days after Prime Minister Narendra Modi held a meeting with domestic manufacturers of the anti-Covid vaccine. . If DCGI allows regular marketing, Covishield will be the second vaccine in the world to receive such approval.

Let us tell you that Pfizer-BioNtech’s Kovid-19 vaccine has received full approval from the US Food and Drug Administration (FDA) for the age group of 16 years and above. Of the more than 102.27 crore doses of anti-Covid-19 vaccine administered in the country so far, about 90 per cent are Covishield and about 10 per cent are Bharat Biotech’s Covaccine vaccine-related doses. Of these, the quantity of Sputnik V vaccine from Russia is less than one percent.

Pune-based SII has submitted its final Phase 2/3 clinical study report for India along with its application for permission for regular marketing for Covishield, official sources said. According to Singh’s application, the company has submitted the results of a phase-3 clinical study of 24,244 subjects from the UK, Brazil and South Africa to the Central Drugs Standard Control Organization (CDSCO) on June 8, 2021. . In addition, the results of a Phase III study involving 32,379 subjects from the US, Chile and Peru were presented on July 9.

According to official sources, Singh has said in the application, “Besides the successful completion of our Phase 2/3 clinical study in India, so far, over 100 crore doses of our Covishield have been delivered to people in our country and around the world.” Singh said in the application, “Such a large-scale vaccination with our Kovidshield vaccine and prevention of Kovid-19 infection is in itself evidence of the safety and effectiveness of Kovidhield.”

Singh expressed his thanks to the DCGI office and the subject expert committee for granting permission for restricted emergency use to Kovishield on January 3. Because of this, the vaccine has played an important role in epidemic control and has been a mainstay of India’s anti-Covid vaccination campaign, he said. “It is a matter of pride for us that we have been a part of the world’s largest vaccination campaign under the dynamic and visionary leadership of our Prime Minister Narendra Modi ji,” Singh is believed to have written in the letter.

He said that under the proper guidance of the Union Health Minister Mansukh Mandaviya, the team of Government of India and under the leadership of Chief Executive Officer Adar C Poonawalla, the team Serum Institute of India to make the world’s largest covid vaccination campaign a success in the manufacture and production of Covishield vaccine. Trying hard to supply. Singh is believed to have said in his application, “In line with our Prime Minister’s call for Atmanirbhar Bharat, we have made our country self-reliant for COVID-19 vaccines. In view of the above facts, we have approved regular marketing of Kovishield. request you to.”




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