Serum India gets DCGI’s nod to manufacture Sputnik V

The Drugs Controller General of India (DCGI) on Friday granted permission to Serum Institute of India (SII) to manufacture Sputnik V, which will allow the production of doses for testing.

"The company applied for a test license which has been granted," confirmed an official in the government familiar with the development, asking not to be named. The actual manufacturing of the vaccine will take time.

A test license, as per the Central Drugs Standards Control Organisation (CDSCO) website, is granted for the import of small quantities of drugs for the purposes of examination, testing or analysis. SII has been given permission to manufacture Sputnik V for the purpose of analysis. The company sought grant of license on Wednesday. The company in its response also said that it has only got preliminary approvals at the moment. "The preliminary permissions are in place. The production will take time. It will take few months," said a company spokesperson.

Sputnik V is currently being distributed in India by Dr Reddy's Laboratories, which signed a pact with the Russian Direct Investment Fund (RDIF), which globally markets the Covid-19 vaccine developed by Russia's Gamaleya Institute.

As part of the deal, Dr Reddy's will distribute the first 250 million doses of Sputnik V. RDIF has also tied up with six other local companies to manufacture its vaccine, and its chief executive officer, Kirill Dmitriev, said earlier that it was also in talks with other manufacturers to ramp up production in India that is likely to start sometime in July.

As per current estimates, RDIF is looking at a production capacity of about 850 million Sputnik V vaccine doses per annum from India. Apart from SII, the companies with which it has entered manufacturing tie up include Hetero Biopharma, Gland Pharma, Stelis Biopharma, Panacea Biotec, and Virchow Biotech.

RDIF, in a statement on May 24, announced that Panacea Biotec launched the production of Sputnik V in India.

"The first batch produced at Panacea Biotec's facilities at Baddi will be shipped to the Gamaleya Center for quality control. Full-scale production of the vaccine is due to start this summer. Company's facilities comply with GMP standards and are prequalified by WHO," the RDIF statement said. Sputnik V was registered in India under the emergency use authorisation on April 12, 2021, and vaccination against Covid-19 started on May 14 under pilot project.

According to Dr Reddy's Labs, they will soon be launching the vaccine in India.