Covishield Producer SII Seeks DCGI Approval To Manufacture Sputnik V Covid Vaccine

The Serum Institute of India (SII), the world's largest vaccine manufacturer, has sought permission from the Drug Controller General of India (DCGI) to manufacture the Sputnik V COVID-19 vaccine in India.

SII CEO Adar Poonawalla

Covid Vaccine Update: The Serum Insititute Of India which is manufacturing the Coronavirus vaccine Covishield has sought permission from the government to manufacture the Russian vaccine Sputnik V in India. The SII has sought the DCGI’s permission for test analysis and examination. In case, it receives a go-ahead, an emergency use authorisation (EUA) would be required.

Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories.

"The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture the COVID-19 vaccine, Sputnik V, in India," a source said.

The Serum Institute plans to manufacture 100 million Covishield vaccines a month from June. Meanwhile, the SII is making Novavax vaccine, but its regulatory clearance from US is awaited.

If all goes well, Sputnik V will be the third vaccine to be manufactured by Pune-based SII after Oxford-AstraZeneca's vaccine, known as Covishield in India, and Novovax's Covovax, which has not received regulatory clearance from the US.

Recently, India received its latest consignment of nearly 3 million doses of the Sputnik V from Russia, making it the third and largest delivery of the imported Covid-19 vaccines. The doses arrived on specially-chartered freighter at Hyderabad Airport in Telangana.

Serum Institute of India which is one of the two Covid vaccine manufacturers in India has sought indemnity protection against liabilities.  Reportedly, Serum Institute of India told the government that all vaccine makers, whether Indian or foreign, should be granted the same protection.