Russia seeks Centre's nod for export of Sputnik Light vaccine produced in India
Russia has urged the central government to allow the export of single-dose Covid vaccine Sputnik Light produced by Hetero Biopharma, PTI reported on Wednesday. Hetero Biopharma is one of the RDIF's (Russian Direct Investment Fund) partners in the production of the vaccine.
Russian ambassador Nicholay Kudashev has requested the Indian government to allow the export of Sputnik Light to his country till the vaccine gets emergency use authorisation from India's drug regulator, the report said.
In a communication to the Centre, Kudashev stated that Hetero Biopharma has already 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, the news agency reported citing sources.
The matter has been referred to the Sub-Group of the National Expert Group on Vaccine Administration for Covid (NEGVAC) for considering Vaccine Export Proposals, the report added.
Earlier, the ambassador had said that the RDIF had 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 RDIF and Dr Reddy's Laboratories are working with the authorities on the registration of the Sputnik Light in India.
In his letter to V K Paul, chair of the NEGVAC, the Russian ambassador said that “Hetero Biopharma, 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," the ambassador was quoted as saying by PTI.
Kudashev further said 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.
If permanent or time-to-time permission could be granted to Hetero 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, he said as per PTI.
Meanwhile, the Drugs Controller General of India's (DCGI) has given permission to Dr Reddy's Laboratory Limited to conduct phase-3 bridging trials in India.