Solan, May 14
Russian-made Covid-19 Sputnik V vaccine received the regulatory clearance from the Kasauli-based Central Drugs Laboratory (CDL) on for its first consignment of imported doses that had arrived in India on May 1.
As part of a limited pilot, the soft launch of the vaccine has commenced and the first dose of the vaccine was administered in Hyderabad on Friday.
“The lab had tested Sputnik V samples received by it on May 3 for toxicity, sterility and other key factors. Its report was sent to the Drug Controller General of India (DCGI) last evening after completion of the testing.” informed a source in the lab.
Russia’s Sputnik V had arrived in India on May 1 and as per the protocol it was sent to CDL Kasauli for testing.
The lab has the mandate of testing all vaccines under the National Regulations of Vaccines produced indigenously for domestic market, immunisation programme of the Government of India, export and for those imported to the country.
As per the protocol laid down by the DCGI, every batch of the vaccine has to be tested and then released before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme. After receipt of the CDL approval, the vaccines can be put to use as per the laid protocol.
Sputnik V had secured the Emergency use authorization on April 12 from the DCGI based on the clinical trails. It had demonstrated an efficacy of 91.6 per cent in the interim analysis of phase 3 clinical trial.
Drug-maker Dr Reddy’s Laboratories had sought emergency use authorisation for this Russian vaccine. It had entering into a partnership with the Russian Direct Investment Fund (RDIF) in September last year to conduct the clinical trials of Sputnik V and for its distribution rights in India.
According to a Dr Reddy’s press release, “The imported dose of the vaccine are presently priced at a MRP of 948 plus 5 per cent GST per dose, with the possibility of lower price point when local supply begins.
