Dr Reddy’s mulls seeking trial waiver for Sputnik Light

HYDERABAD: Dr Reddy’s Laboratories is mulling approaching drug regulatory authorities to seek waiver for separate clinical trials of Sputnik Light, the single-dose version of Russian Covid-19 vaccine Sputnik V recently approved in Russia.
Russian Direct Investment Fund’s (RDIF) Indian partner is also exploring the possibility of seeking a waiver of the requirement for each local Sputnik V manufacturer to conduct separate clinical trials and seek regulatory approvals as part of the process of speeding up the deployment of locally made doses, a top Dr Reddy’s Laboratories official said on Monday.
Hetero Group, which has been roped in for manufacturing over 100 million doses, has already got regulatory approval for conducting Phase III clinical trials of the locally made Sputnik V on around 300 volunteers to test if it is at par with the imported vaccine.
“…we are working with the Indian regulator to understand what is the optimal way to do this. This being a technology transfer, not a redevelopment, there is a possibility to be able to avoid it (separate trial)…it is not clear as of now so we will…work with the regulator to bring some guidance on how to do this,” said Dr Sauri Gudlavalleti, head of R&D and IPDO, Dr Reddy’s.
On Sputnik Light, he said: “We are collecting all the data and evidence that formed the basis for Sputnik Light to be approved in Russia. Once we have the data and are in a position to submit it, which I expect will happen in the next few weeks,… we will submit that and seek feedback from the regulator…we will have to work with the regulator to see if the evidence is adequate to waive the trial...,” he said.