Last Updated on December 31, 2023 by The Health Master
India’s drug regulator, the Drugs Controller General of India (DCGI), approved the Serum Institute of India’s proposal to manufacture a drug substance for the new C-19 vaccine against the Omicron variant of coronavirus and carry out its testing and analysis, official sources said.
The move assumes significance in view of the country’s reporting a rise in daily new C-19 cases, which include the Omicron variant.
Looking to undertake vaccine research against the Omicron variant, Director, Government and Regulatory Affairs at SII, Prakash Kumar Singh, recently submitted an application to the Drugs Controller General of India (DCGI) for the grant of permission to manufacture drug substances of SARS-CoV-2 rS Protein (C-19) Recombinant Spike Nanoparticle Vaccine (Omicron Variant) for examination test and analysis.
“As you are aware, the new coronavirus variant ‘Omicron’ has already been reported in more than 60 countries and is spreading very fast worldwide and in our country also.
Our CEO Adar C Poonawalla is very much concerned about the protection of citizens of our country and world at large against coronavirus and its new variants, and we are relentlessly working on development of SARS-CoV-2 rS Protein (C-19) Recombinant Spike Nanoparticle Vaccine (Omicron Variant),” an official source quoted Singh as having said in the application.
Development of this vaccine shall be another example of vaccine production strength of India in line with the clarion call of Prime Minister Narendra Modi “Making in India for the World” and shall further keep our country’s flag flying high globally, he said.
An official source informed us that after the review of their application, DCGI has given permission to manufacture SARS-CoV-2 rS Drug Substance (Omicron Variant) for Examination, Test, and Analysis (for the SIIPL Hadapsar site).
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