SII Gets DCGI Nod To Manufacture Drug Substance, Test It For Developing Jab Against Omicron

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India's drug regulator on Friday approved Serum Institute of India's proposal to manufacture a drug substance for the new Covid 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 reporting a rise in daily new Covid-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 had submitted an application to the Drugs Controller General of India (DCGI) for grant of permission to manufacture Drug substance of SARS-CoV-2 rS Protein (Covid-l9)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 the development of SARS-CoV-2 rS Protein (Covid-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.

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 SIIPL Hadapsar site), an official source informed.