Hetero Biopharma, the biologics arm of pharma manufacturer Hetero, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture Russian Covid vaccine Sputnik Light for sale in India with restricted emergency use.
Hyderabad-based Hetero is the first biopharmaceutical company in India to receive manufacturing & marketing (M&M) approval for the product manufactured locally for the prevention of Covid in adults aged over 18 years. It is administered in a single dose of 0.5ml.
Russian Direct Investment Fund’s (RDIF) Sputnik Light is the first component (recombinant human adenovirus serotype number 26 of Sputnik V.
In February 2022, the Drugs Controller General of India (DCGI) granted emergency use permission to single-dose Sputnik Light Covid vaccine in India.
“Clinical data of Sputnik Light (Component I of Sputnik V) had shown significantly high titers of antibodies against Covid, both glycoprotein-specific and virus-neutralising antibodies, along with CD4 & IFN-γ levels. Sputnik Light has also shown its neutralising activity against Omicron variant of SARS CoV-2 virus,’‘ said Shubhadeep Sinha, Senior V-P &Head, Clinical Development & Medical Affairs (CDMA), Hetero, in a release on Monday.
Earlier, Sputnik V clinical trials globally had shown significant protection against Covid, including other subtypes, he added.