SII has obtained permission and licence to manufacture SARS-CoV-2rS drug substance for examination, test and analysis.
The Drugs Controller General of India (DCGI) has approved Serum Institute of India’s proposal to manufacture a vaccine against omicron variant of coronavirus for examination, test and analysis, official sources said on Monday.
“With reference to your application, please find herewith the permission to manufacture SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein nanoparticle vaccine (omicron variant) for examination, test and analysis under the provisions of New Drugs and Clinical Trials Rules, 2019 to manufacture the test batches of the drug/drugs mentioned therein,” an approval order issued on February 4 stated.