July 2, 2021
1 min read

Sputnik Light can submit Russian data for approval in India

The SEC, at its meeting on Wednesday, deliberated on the submission for marketing authorisation of Sputnik Light from Dr Reddy’s….reports Asian Lite News

Sputnik Light, the single-dose Covid-19 vaccine, can submit Russian safety data for approval in India, Dr Reddy’s Laboratories said on Thursday.

The Hyderabad-based Dr Reddy’s, in a statement, said that the Subject Expert Committee (SEC) under Drugs Controller General of India (DCGI) asked it to submit safety, immunogenicity and efficacy data from the Phase 3 clinical trial of Sputnik Light in Russia for consideration of marketing authorisation of Sputnik Light in India.

The SEC, at its meeting on Wednesday, deliberated on the submission for marketing authorisation of Sputnik Light from Dr Reddy’s. The company presented to the SEC, interim safety and efficacy data from the Phase 1/2 clinical trial of Sputnik Light in Russia, along with a clinical trial protocol for a Phase 3 trial of Sputnik Light in India.

The SEC made the recommendation 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 3 efficacy trial is currently underway in Russia on Sputnik Light.

“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 3 trial of Sputnik Light in India,” the statement said.

Sputnik Light is a single dose Covid-19 vaccine from the makers of Sputnik V and is yet to be approved in India.

ALSO READ: 7 EU nations clear Covishield amid travel pass row

Previous Story

33 Taliban terrorists killed in Afghan airstrikes

Next Story

Indian researchers design mobile group oxygen concentrator

Latest from -Top News

Zero Tariffs? Trump Claims Big Win Over India

Trump Claims India to Eliminate Tariffs on U.S. Imports..reports Asian Lite News U.S. President Donald Trump announced on Tuesday that India has either already removed or is in the process of removing

Khaleda Zia Returns to Bangladesh

As Khaleda Zia travelled to her Gulshan residence from the airport, hundreds of party workers lined the streets to welcome her return…reports Asian Lite News BNP Chairperson Khaleda Zia Returns to Dhaka

UNSC Grills Pakistan Over Pahalgam Attack

Though Pakistan claimed that the meeting largely served and achieved the objectives of the UNSC’s meeting, reports showed that it flopped miserably…reports Asian Lite News The United Nations Security Council (UNSC) reportedly
Go toTop

Don't Miss

Chinese medical suppliers see surge in orders from India

The suspension of China’s Sichuan Airlines’ cargo flights to India

China probe will determine Democratic Party fate

It is a matter of astonishment that Biden believes that