Hetero receives CDSCO approval to manufacture Sputnik Light vaccine for sale in India

Hetero Pharma announced today that its biologics arm ‘Hetero Biopharma’ has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture for sale, Sputnik Light, with restricted emergency use in India. Hetero is the 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 single dose of 0.5ml. All other currently approved vaccines in India require two doses of administration.

In a statement, Hetero said that Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against coronavirus disease, COVID-19. In February 2022, the Drugs Controller General of India (DCGI) had granted emergency use permission to the 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 along with CD4 & IFN-γ levels. Sputnik Light has also shown its neutralising activity against Omicron variant of SARS CoV-2 virus. Earlier, Sputnik V clinical trials globally had shown significant protection against COVID-19, including other subtypes,” said Dr Shubhadeep Sinha, Senior VP and Head – Clinical Development and Medical Affairs (CDMA), Hetero, in the statement.