Last Updated on January 5, 2024 by The Health Master
The Drugs Controller General of India (DCGI) has approved the Serum Institute of India’s proposal to manufacture a vaccine against the omicron variant of the C-19 virus for examination, testing, and analysis, according to official sources said yesterday.
“With reference to your application, “please find herewith the permission to manufacture SARS-CoV-2 rS Protein (C-19) recombinant spike protein nanoparticle vaccine (omicron variant) for examination, test, and analysis under the provisions of the New Drugs and Clinical Trials Rules, 2019 to manufacture the test batches of the drug/drugs mentioned therein,” an approval order issued on February 4th stated.
Prakash Kumar Singh, Director, Government and Regulatory Affairs, SII, had put in an application to the DCGI on 6th January stating the Pune-based firm, in collaboration with Novavax Inc, is working on the development of a vaccine against omicron, an official source said, adding that the SII has obtained permission and a license to manufacture SARS-CoV-2rS drug substance for examination, testing, and analysis.
“The new C-19 virus variant ‘omicron’ has already been reported in more than 60 countries and is spreading very fast worldwide and in our country also. Our CEO, Dr Adar C Poonawalla, is very concerned about the protection of citizens of our country and the world at large against C-19 virus and its new variants, and we are relentlessly working on the development of a SARS-CoV-2 rS Protein (C-19) recombinant spike nanoparticle vaccine (omicron variant).
“Development of this vaccine shall be another example of the vaccine production strength of our country in line with the clarion call of our prime minister, “Making in India for the World” and shall further keep our country’s flag flying high globally,” Singh had stated in the application,” source said.
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