DCGI accords Dr. Reddy’s permission to import Sputnik V (Ld)


Dr. Reddy’s Laboratories (DRL), the city based pharmaceutical major on Tuesday said it received permission from the Drugs Controller General of India (DCGI) to import Sputnik V vaccine into India for restricted use in emergency situations.

“We are very pleased to obtain the emergency use authorization for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against Covid,” said DRL’s co – chairman and managing director G.V. Prasad.

According to the Hyderabad-based company, emergency use will be as per the provisions of the new drug and clinical trials rules, 2019 under the Drugs and Cosmetics Act.

The pharmaceutical major partnered with Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials of Sputnik V and distribute the vaccine in India.

“In addition to the trials conducted in Russia by RDIF. Phase II/III clinical trials of the vaccine were carried out by Dr. Reddy’s in India,” said a company official.

As per DRL’s statement, Sputnik V is approved to tackle coronavirus in 60 countries across the world, including ranking second among coronavirus vaccines globally in terms of the number of approvals issued by the government regulators.

“Sputnik V uses two different vectors for the two shots in a course of vaccination. The efficacy of Sputnik V was determined to be 91.6 per cent as per a published article in the Lancet, one of the world’s oldest and most respected medical journals,” said the official.

Considering the shortage of vaccines being experienced by many Indian states, DRL received DCGI’s permission within a day’s time after the subject expert committee (SEC) approved its application for the Russian vaccine candidate Sputnik V.