Serum seeks DCGI's nod to manufacture Sputnik V; Centre books 30 crore doses

New Delhi: 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 for examination, test and analysis at its licensed Hadapsar facility in Pune, official sources said on Thursday.

United States Vice-President Kamala Harris on Thursday spoke with Prime Minister Narendra Modi and conveyed that the US will begin sharing vaccines with India, along with other countries by end of June. Following this, Prime Minister Modi thanked her for all the support and solidarity from the US government, businesses and the Indian diaspora. "I deeply appreciate the assurance of vaccine supplies to India as part of the US Strategy for Global Vaccine Sharing," he wrote on Twitter.

US President Joe Biden has also announced his plan to share some 25 million of a planned 80 million Covid-19 vaccines with the rest of the world. The United States will donate nearly 19 million doses of its Covid-19 vaccine through the COVAX facility, he said in a statement.

The Centre, on the other hand, after facing the Supreme Court rap over poor vaccination strategy, finalised arrangements with Hyderabad-based vaccine manufacturer Biological-E to reserve 30 crore COVID-19 vaccine doses. The vaccine produced by Biological-E is still in clinical trials and the ministry would make an advance payment of Rs 1,500 crore to the manufacturer to ensure the availability of life-saving shots.

According to the Health ministry's statement, these doses will be manufactured and stockpiled by Biological-E from August to December this year.

Serum has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, for developing Sputnik V at its Hadapsar facility.

On May 18, the SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for the import of strains or seed lots and cell banks and for carrying out research and development, the sources said.

The RCGM has raised certain queries over the SII's application and sought a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology. Russia's Sputnik V vaccine is currently being manufactured by Dr Reddy's Laboratories in India.

"The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture COVID-19 vaccine Sputnik V for examination, test and analysis at its licensed Hadapsar facility," an official source said. Once these approvals are received, the SII plans to seek restricted emergency use permission for the vaccine in India.

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 proposal of Biological-E was examined and recommended for approval after due diligence by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), the ministry said.

The arrangement with Biological-E is part of the wider endeavour of the Centre to encourage indigenous vaccine manufacturers by providing them support in research and development and also financial support, it said, adding that the Biological-E COVID vaccine candidate has been supported by the Centre from the preclinical stage to phase-3 studies.

Meanwhile, Reliance Industries Ltd's R&D arm has proposed the use of Niclosamide - the drug used to treat tapeworm infestation - for treating COVID-19 patients.

Niclosamide, a drug on the World Health Organisation's list of essential medicines, has been used to treat tapeworm infestation for more than 50 years. The oral antiviral drug was also used to treat patients during the SARS outbreak of 2003-04.

"The company submitted a proposal for the application of Niclosamide as a potential drug against COVID-19," the firm's latest annual report said.

The drug regulator will now evaluate the proposal for public use.