New Delhi: Russian Ambassador has urged the Indian government to allow export of sputnik light for a single dose vaccine produced by hetero, one of the RDIF partners in the production of Jab, to the country until the vaccine uses an emergency authorization from Indian drug regulators.
In Communication to the Center, Russian Ambassador Nicholay Kudashev stated that Hetero Biopharma Limited has produced one million component doses 1 of Sputnik V and two million-dose of sputnik but the save age of six months vaccine can expire the previous registration which will produce a waste of vaccine doses, said source .
Sputnik-Light is the same as component-1 Sputnik V.
The problem is discussed in a recent empowered Group 5 meeting, has referred to the national group sub-groups on the vaccine administration for Covid-19 (Negvac) to consider the proposal export vaccine , said source.
Over the past few months, Direct Russian investment funds (RDIF) have worked with Indian pharmaceutical companies to increase the production of sputnik vaccines in India that can be used in the local and global markets, the ambassador states in its last month’s communication.
Currently RDIF along with the Laboratory Dr.
Reddy works with the authorities concerned at the registration of sputnik light in India.
“Hetero Biopharma Limited, one of the leading Indian pharmaceutical companies and RDIF partners in the production of Sputnik Light, has produced one million doses of components I Sputnik V vaccines and two million doses of sputnik light and intends to continue further production.” However, the period of saving life The vaccine, which is only 6 months, can expire before registration, which will result in waste of several million doses of a very important sputnic light vaccine.
“We want to note that Indian producers of the Russian vaccine are discouraged by the current prohibition that prevents the use of sputnic light vaccines produced in India and exports to other countries,” Communication to VK Paul, national chairman.
Expert group on vaccine administration for Covid-19 (Negvac).
If permanent permission or time-time can be given to Hetero Biophar is limited to exporting the Sputnik Light vaccine produced by selling it to RDIF until the registration in India, this can encourage the company to increase vaccine production and provide the Indian market with more supply of sputnik light During the regulation approval, he said.
Meanwhile, Sputnik Light has received permission for drug controllers (DCGI) India to conduct trial bridging phase-3 in India.
DCGI’s permission is based on the recommendation by the Subject Expert Committee in Covid-19 Central Medicine Standard Control Organization (CDSCO), which holds its meeting 5.
Recommendations SEC states that the company presents security, immunogenicity, and updated efficacy.
Clinical Test Data Phase-3 Virus Vaccine SARS-COV-2 – (Sputnik Light) – Single dose vaccine is carried out in Russia along with a proposal to conduct clinical trial phase 3.
The committee notes that the company has now presented safety and immunogenicity along with longevity of antibodies Which gives the size of the persistence of antibodies to participants.
After detailed consideration, the committee recommends giving permission to conduct clinical trials bridging phase-3 in the Indian population on the condition that the main endpoint must be assessed on day 42, 90 and 180 and temporary analysis can be made on day 42 because this data is not produced During Sputnik V trials in India after the first dose, which was stated to be available until the 21st day.
In July, the Expert Committee for the Standard Control Organization Center (CDSCO) Center has refused to authorize emergency use for sputnik light.