Serum Institute applies to DCGI to Manufacture Sputnik V Vaccine

The Serum Institute of India (SII) has applied to the Drug Controller General of India (DCGI) seeking permission to manufacture COVID-19 vaccine Sputnik V in the country, sources said.

The Pune-based vaccine manufacturing firm has also sought approval for test analysis and examination. Russia’s Sputnik V vaccine is currently being manufactured in India by Dr Reddy’s Laboratories.

The Serum Institute of India already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufactured Novavax vaccine, the regulatory clearance for which is awaited from the United States.

The vaccines were given emergency use authorization (EUA) by the Drug Controller General of India in April. A consignment of 30 lakh doses of Sputnik V arrived in Hyderabad on Tuesday.

Earlier last year, SII CEO Adar Poonawala had advocated for indemnity for all vaccine manufacture. “We need to have the government indemnify manufacturers, especially vaccine manufacture, against all lawsuits. Frivolous claims come up and you see in the media something being blown out of proportion. The government needs to step in with the right messaging,” he had said.

Serum Institute of India is an Indian biotechnology and biopharmaceutical company. It is the world’s largest vaccine Manufacture Company. It is located in the city of Pune, Maharashtra, India. Cyrus Poonawalla was founded in 1966.

Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax, and Biological-E are among the domestic pharma firms working on the coronavirus vaccines in India.