Pune-based Serum Institute of India (SII) has sought permission from the Drug Controller General of India (DCGI) to manufacture the Russian-developed coronavirus vaccine Sputnik-V.
According to information coming from quoting sources, SII had submitted an application to DCGI on Wednesday.
Hyderabad-based Dr Reddy’s Laboratories had trialled it in India, and it is also going to start production of Sputnik-V from August.
If Serum Institute gets approval for Sputnik-V production in India, it will be an essential step in the vaccination campaign. Serum Institute is the world’s largest company in terms of vaccine production.
If the company produces Sputnik-V, the third coronavirus vaccine will be made at the Serum Institute. SII is already producing AstraZeneca’s Covishield and will start producing Novavax’s Kovavax vaccine in a few days.
SII to produce 100 million doses of Covishield in June
SII has informed the Government of India that it will produce 100 million quantities of Covishield in June. Covishield is being used prominently in the country’s vaccination campaign. At the same time, Kovavax is yet to get regulatory approval from the US.
Sputnik-V was approved in April
Sputnik-V was approved for emergency use in India on 13 April. India was the 60th country to flag it off. This is the second most approved vaccine so far. This vaccine has been developed by genetically modifying the human adenovirus that causes the common cold. In trials conducted in many countries, Sputnik-V was found to be 91.6 per cent effective, and it is one of the most effective vaccines for corona.
Mass production will start in August.
Dr Reddy’s Lab is expected to start mass production of Sputnik-V in August. Before that, it is being imported from Russia. Its first consignment reached Hyderabad on 1 May, and its use also started. Currently, the Sputnik-V being imported from Russia costs 995 per dose. However, the company says that its prices may come down once production begins in India.
85 crore doses will be made every year in India
Russian Direct Investment Fund (RDIF) CEO Kirill Dmitriev, which gave financial help to make this vaccine, had said that 85 crore doses of this vaccine would be produced every year in India. According to the DTE report, RDIF has joined hands with five Indian companies, including Dr Reddy’s, to speed up vaccine production. These companies include Hetero Pharma, Gland Pharma Limited, Stelis Biopharma Private Limited and Virkov Biotech Limited.
One-dose version may soon get approval
Sputnik Lite, a single-dose version of the two-dose Sputnik-V, may also get approval in India soon. The Government of India is planning to launch Sputnik Lite, a single-dose vaccine of Sputnik-V, soon.
For this, the government has asked all stakeholders to fast-track the process of application and regulatory approvals. A request can be made to DCGI for its approval in the next 2-3 weeks.