Serum Institute of India applies to DCGI to manufacture Sputnik V COVID vaccine, seeks indemnity

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

The Pune-based firm has also sought approval from the DCGI 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 (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.

Amid discussions over possible legal protection to foreign vaccine manufacturers Pfizer and Moderna over their COVID-19 jabs in India, the SII has also sought protection against liabilities.

“Not just Serum Institute of India, all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted the same,” sources added.

Earlier last year, SII CEO Adar Poonawala had advocated for indemnity for all vaccine manufacturers. “We need to have the government indemnify manufacturers, especially vaccine manufacturers, 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.

Amid the nationwide COVID-19 vaccine crunch, US pharma giant Pfizer is seeking an indemnity bond that will exempt it from legal claims in case there are any adverse effects from the vaccine.

NITI Aayog Member (Health) Dr VK Paul had said on May 27 that the government is still examining the American pharma company`s request for indemnity.

Meanwhile, the SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.

The vaccine was given emergency use authorisation (EUA) by the DCGI in April. A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday. 

Bureau Report