Expert panel permits Dr Reddy’s to submit Sputnik Light Russian phase III data in India
On Wednesday, the Subject Expert Committee (SEC) deliberated on the submission for Marketing Authorisation of Sputnik Light in India from Dr Reddy’s
Hyderabad: Hyderabad-based pharmaceuticals company Dr Reddy’s Laboratories on Thursday said that the single-dose Sputnik Light vaccine can submit Russian safety data for approval in India. Sputnik Light is a single dose Covid-19 vaccine from the makers of Sputnik V and is yet to be approved in the country.
On Wednesday, the Subject Expert Committee (SEC) deliberated on the submission for Marketing Authorisation of Sputnik Light in India from Dr Reddy’s. The company presented to the SEC, interim safety and efficacy data from the phase I / II clinical trial of Sputnik Light in Russia, along with a clinical trial protocol for a phase III trial of Sputnik Light in India.
In view of the fact that Sputnik Light is the first dose component of Sputnik V, and Dr Reddy’s has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and; a phase III efficacy trial is currently underway in Russia on Sputnik Light, the SEC recommended that Dr Reddy’s should submit safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik Light in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India.
“Further, the SEC also observed that in view of the safety and immunogenicity data already generated by Dr Reddy’s in India on the first dose component of Sputnik V (in other words, Sputnik Light), there was no need for a separate phase III trial of Sputnik Light in India,” Dr Reddy’s said in a statement.
The company’s clarification comes amid reports of SEC denying permission to Dr Reddy’s for conducting phase 3 trials of Russia’s Covid-19 vaccine Sputnik Light in India.
Now you can get handpicked stories from Telangana Today on Telegram everyday. Click the link to subscribe.
Click to follow Telangana Today Facebook page and Twitter .
