NEW DELHI: The Russian ambassador has urged the Indian government to allow the export of single-dose COVID-19 vaccine Sputnik Light produced by Hetero, one of the RDIF's partners in the production of the jab, to his country till the vaccine gets emergency use authorisation from India's drug regulator.
In a communication to the Centre, Russian Ambassador Nicholay Kudashev stated that Hetero Biopharma Limited already has manufactured one million doses of Component 1 of the Sputnik V and two million doses of the Sputnik Light but the six-month shelf life of the vaccine may expire before its registration which will result in the wastage of vaccine doses, sources said.
The Sputnik-Light is the same as component-1 of Sputnik V.
The issue, which was discussed in the meeting of the Empowered Group 5 recently, has been referred to the Sub-Group of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) for considering Vaccine Export Proposals, the sources said.
Over the past months, the Russian Direct Investment Fund (RDIF) has been working closely with Indian pharmaceutical companies to ramp up the production of the Sputnik vaccine in India that could be used in the local and global markets, the ambassador stated in his communication last month.
At the moment RDIF together with Dr Reddy's Laboratories is working with the authorities concerned on the registration of the Sputnik Light in India.
"Hetero Biopharma Limited, one of the leading Indian pharmaceutical companies and RDIF's partner in the production of the Sputnik Light, has already manufactured one million doses of Component I of the Sputnik V vaccine and two million doses of the Sputnik Light and intends to continue its production further.
"However, a shelf life tenure of the vaccine, i.e. 6 months only, may expire before its registration, which will result in the wastage of several million doses of the vitally important Sputnik Light vaccine.
"We would like to note that Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the produced Sputnik Light vaccine in India and its export to other countries," said the communication to V K Paul, chair of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
If permanent or time-to-time permission could be granted to Hetero Biophar Limited to export the produced Sputnik Light vaccine by selling it to RDIF until its registration in India, this could encourage the company to scale up the production of the vaccine and provide the Indian market with more supplies of the Sputnik Light by the moment of its regulatory approval, it said.
Meanwhile, Sputnik Light has received the Drugs Controller General of India's (DCGI) permission to conduct phase-3 bridging trials in India.
The DCGI's permission was based on the recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation(CDSCO), which held its meeting on August 5.
The SEC recommendations stated that the firm presented updated safety, immunogenicity and efficacy data of Phase-3 clinical trial of SARS-CoV-2 virus Vaccine - (Sputnik Light) – single-dose vaccine conducted in Russia along with the proposal to conduct phase 3 clinical trial.
The Committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of persistence of antibodies in the participants.
After detailed deliberation, the committee recommended for grant of permission for conduct of phase-3 immune-bridging clinical trial in the Indian population subject to the condition that the primary endpoint should be assessed at day 42, 90 and 180 and interim analysis can be conducted at day 42 as this data was not generated during the Sputnik V trial in India after the first dose, which was stated to be available up to day 21 only.
In July, the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) had refused to grant emergency-use authorisation for Sputnik Light.