Drug firm Hetero on Monday said its biologics arm has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell Sputnik Light for restricted emergency use in India.
Hetero is the first biopharmaceutical company in India to receive Manufacturing and Marketing (M&M) approval for the product manufactured locally for the prevention of COVID-19 in adults aged over 18 years, administered in a single dose of 0.5 ml, the company said in a statement. All other currently approved vaccines in India require two doses of administration, it added.
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V the world’s first registered vaccine against COVID-19. In February 2022, the Drugs Controller General of India (DCGI) granted emergency use permission to single-dose Sputnik Light COVID-19 vaccine in India.
“Clinical data of Sputnik Light (Component I of Sputnik V) had shown significantly high titers of antibodies against COVID-19, both glycoprotein specific and virus-neutralising antibodies… Sputnik Light has also shown its neutralising activity against Omicron variant of SARS CoV-2 virus,” Hetero Senior VP & Head – Clinical Development & Medical Affairs (CDMA) – Shubhadeep Sinha said. Earlier, Sputnik V clinical trials globally showed significant protection against COVID-19, including other subtypes, he added.