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Serum Institute seeks permission for manufacturing Sputnik V, indemnity


Pune-based Serum Institute of India (SII) has sought permission from the Drug Controller General of India (DCGI) for manufacturing Sputnik V—the Russian vaccine against COVID-19. The application was made yesterday, according to media reports.

Notably, SII, the biggest vaccine maker in the world, is already manufacturing Covishield—the COVID-19 vaccine developed by AstraZeneca and the University of Oxford.

The vaccine maker has already informed the Centre that it will be able to supply around 10 crore doses of Covishield in June. SII is also manufacturing the Novavax vaccine for which regulatory clearance is awaited from the United States.

Sputnik V

The vaccine has been developed by Russia’s Gamaleya Research Institute and approved by the Indian drug regulator for emergency use in April. As of now, only Dr Reddy’s Laboratories is manufacturing the Russian vaccine in India and extremely limited supplies of the vaccine is available in the country.

Also Read: Centre to procure 30 cr doses of 2nd made-in-India vaccine that is still undergoing clinical trials

Meanwhile, a consignment of 30 lakh doses of the vaccine recently arrived in Hyderabad.

Serum Institute seeking indemnity

With Pfizer and Moderna seeking indemnity from liability for their jabs and the government likely to provide it, the Serum Institute of India, too, is seeking legal protection from liabilities. The company has told the government that all domestic vaccine makers should be granted indemnity from liability for their vaccines, if foreign vaccine makers are granted the same. It said that rules should be the same for everyone.

While the government has not provided indemnity to any vaccine maker so far, it is one of the key clauses put forth by US-based vaccine makers for supplying their jabs in India. With a wide gap between demand and supply of vaccines, the Indian government is desperate to procure vaccines from foreign vaccine makers to meet the domestic demand and fast-track the country’s vaccination drive.

So far, 22.10 crore doses of the vaccines have been administered in the country. Over 17.56 crore people have taken their first dose, whereas only 4.53 crore people have taken both doses of the vaccines.


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