Regulatory approval to Sputnik V

Ambika Sharma
Tribune News Service
Solan, May 14

Russian-made Covid-19 vaccine Sputnik V received regulatory clearance from the Central Drugs Laboratory (CDL), Kasauli, yesterday for its first consignment of imported doses that had arrived in India on May 1. This would pave the way for its roll-out. The Union Health Ministry had announced yesterday that Sputnik V may be rolled out by next week.

“The lab tested Sputnik V samples received on May 3 on various parameters and sent its report to the Drugs Controller General of India (DCGI) Thursday evening,” said a source in the CDL.

As per the protocol laid down by the DCGI, every batch of the vaccine has to be tested before release for use, as per the guidelines issued under the National Covid-19 Vaccination Programme. After the CDL approval, the vaccine can now be used, as per the protocol.

The DCGI had granted the emergency use authorisation to Sputnik V on April 12 on the basis of the clinical trails. The vaccine demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase-III trial.

Drug-maker Dr Reddy’s Laboratories (DRL) had sought the emergency use authorisation for Sputnik V