Hetero gets CDSCO nod to make & sell Sputnik Light vaccine in India

Drug maker Hetero on Monday said that its biologics arm Hetero Biopharma has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell Sputnik Light, with restricted emergency use in India.

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-19 in adults aged over 18 years, administered in single dose of 0.5ml. The approval will allow Hetero to sell the vaccine directly in the domestic market.

All other currently approved vaccines in India require two doses of administration.


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, Dr Reddy's said it had received emergency use approval from the Drugs Controller General of India (DCGI) for 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-neutralizing antibodies along with CD4 & IFN-γ levels," said Dr. Shubhadeep Sinha, senior vice-president & head of Clinical Development & Medical Affairs (CDMA) at Hetero.

"Sputnik Light has also shown its neutralizing activity against the Omicron variant of SARS CoV-2 virus. Earlier Sputnik V clinical trials globally had shown significant protection against COVID-19 including other subtypes,” Sinha added.