Hetero Biopharma, the biologics arm of drugmaker Hetero, has received the Central Drugs Standard Control Organisation’s (CDSCO) approval to manufacture and sell Sputnik Light, the Russian single dose vaccine against COVID-19, in India.
It is the first biopharmaceutical company in the country to receive manufacturing and marketing approval for the product manufactured locally. “All other currently approved vaccines in India require two doses of administration,” Hetero said in a release on Monday.
Sputnik Light is the first component of the two-dose Russian COVID-19 vaccine Sputnik V, which has been approved by India and used as part of the inoculation programme. In February, the Drugs Controller General of India had granted emergency use permission to the single-dose Sputnik Light.
“Clinical data of Sputnik Light had shown significantly high titers of antibodies against COVID-19, 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 VP and Head — Clinical Development and Medical Affairs at Hetero.
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