New Delhi: The government is expectant of a speedy launch of the single-dose Sputnik Light vaccine in India. For this, all the stakeholders including the Russian manufacturer and its Indian partners are directed to fast-track the process and regulatory approval procedures for the dose to boost the country’s vaccination drive program.
As informed by the Drugs Controller General of India (DCGI), an application seeking regulatory approval for Sputnik Light is expected to be filed in the next 2-3 weeks. With this, it could become the first single-dose vaccine to be launched in India. The sources said this after quoting high-level discussions held among top government officials in recent days to boost domestic availability of COVID-19 vaccines nationwide.
The Cabinet, at a meeting last week, suggested immediately summon a meeting with all concerned stakeholders including the Drugs Controller General of India (DCGI), Department of Biotechnology Secretary, the Ministry of External Affairs representatives, the Union Health Ministry officials, RDIF (Russian Direct Investment Fund) and few domestic manufacturers to hasten the regulatory approvals for Sputnik Light vaccine. Dr. Reddy’s Laboratories Ltd had earlier applied for the grant of permission to import and market Sputnik-V vaccine, developed by Gamaleya Institute, Russia, for emergency use authorization in India.
Along with the rollout of Sputnik’s one-dose jab, the issue of the criticality of recombinant Adenovirus Type-5 (aAd-5) component will also become unnecessary. Russia has already approved this vaccine and various trials have been started in other countries as well.
According to sources, another highlight of the meeting was the discussion regarding the availability of 6 Lakh imported double-dose of Sputnik-V in May 2021, 1 crore imported doses in June 2021, and 2.8 crore doses (2.4 Crore imported and 40 Lakh manufactured in India) in July 2021. From the month of August 2021, the locally manufactured Sputnik V vaccine will be available in the domestic market for medical use.
Also, for the manufacturing of Sputnik-V vaccine and technology-transfer arrangement for the same has been made clear and detailed with six Indian manufacturers. The Department of Biotechnology along with the Central Drugs Standard Control Organisation (CDSCO) is in touch with all these manufacturers to provide the necessary support to them in setting up their manufacturing facilities and other related issues. The single-dose Sputnik Light in the domestic market can significantly boost the country’s vaccination drive on a large scale.
Dr. Reddy’s Laboratories is responsible for importing the two-dose Sputnik V vaccine for use in India. With many states reporting a shortage of vaccines, the government is looking to ramp up domestic manufacturing of vaccines, including those made by Serum Institute and Bharat Biotech, among other Indian manufacturers currently in various stages of their vaccine production.
Besides, the government is also trying to secure imported doses, including Russia’s Sputnik vaccines, while talks are also underway for the possibility of COVID-19 vaccines developed by US majors Pfizer and Moderna.