Government expects speedy launch of Sputnik Light in India
What's the story
The government is hopeful of a speedy launch of the single-dose COVID-19 vaccine Sputnik Light in India. All stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive. An application seeking regulatory approval is expected to be filed in the next couple of weeks.
Information
Sputnik Light could become first single-dose vaccine in India
Sources say that Sputnik Light could become the first single-dose vaccine to be launched in India. High-level discussions have been held among top government officials in recent days to boost the domestic availability of COVID-19 vaccines.
Meeting
A meeting with all concerned stakeholders is expected soon
At a meeting chaired by the Cabinet Secretary last week, it was suggested to immediately convene a meeting with all concerned stakeholders. These include the Department of Biotechnology Secretary, Drugs Controller General of India (DCGI), the Ministry of External Affairs representatives, the Union Health Ministry officials, RDIF (Russian Direct Investment Fund), and domestic manufacturers to expedite the regulatory approvals for Sputnik Light.
Approval
Application for regulatory approval expected in the next few weeks
Russia has already approved this vaccine and trials are ongoing in other countries. DCGI meanwhile informed that the application for regulatory approval is expected to be filed in the next 2-3 weeks. Further, six lakh imported double-dose of Sputnik V will be available in May 2021, one crore in June, and 2.8 crore doses (2.4 crore imported, 40 Lakh manufactured in India) in July.
Manufacture
Locally manufactured Sputnik V vaccine will be available from August
August 2021 onwards, locally manufactured Sputnik V vaccine will be available in the domestic market and technology-transfer arrangement for its manufacturing has been firmed up with six Indian manufacturers, sources added. The Department of Biotechnology and the Central Drugs Standard Control Organisation (CDSCO) are in touch with all these manufacturers to provide the necessary support to them in setting up their manufacturing facilities.
Problem
Recombinant Adenovirus Type-5 in second dose has posed a problem
It was also flagged during a meeting that domestic manufacturers are not very comfortable with the production of recombinant Adenovirus Type-5 (rAd-5) component, which is used in the second dose of vaccine, due to its low yield and their inability to fully absorb its production process. Another round of meeting with the manufacturers and RDIF will be held soon to resolve this issue.
Information
Dr. Reddy's Laboratories is importing the vaccine in India
Sputnik V had received permission for restricted emergency use on April 12. Dr. Reddy's Laboratories is importing the vaccine for use in India. The interim results of safety immunogenicity and efficacy from the Russian Phase III clinical trial have been published in The Lancet journal.