New Delhi, October 8: India has reportedly turned down a proposal from pharma major Dr Reddy's Laboratories Ltd for testing Russian COVID-19 vaccine candidate Sputnik V in a large study. According to a report from Reuters, an expert panel of the Central Drugs Standard Control Organisation (CDSCO) refused to give a nod for conducting both phase-2 and 3 human clinical trials in India for Sputnik V and asked Dr Reddy's Lab to first test the vaccine in a smaller trial.
Dr Reddy's Lab had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of Sputnik V. Two days ago, news agency PTI reported, quoting sources, the CDSCO had asked Dr Reddy's Laboratories to submit a revised protocol for conducting both phase-2 and 3 human clinical trials in India for the Russian vaccine. Dr Reddy's has collaborated with the Russian Direct Investment Fund to conduct clinical trials of Sputnik V vaccine and for its distribution.
Earlier this week, Union Health Minister Harsh Vardhan also said that the government is yet to take a final decision on phase-3 trials of Sputnik V in India. "This issue is still under consideration and no final decision on Sputnik V vaccine developed by Russia has been taken as yet," he had said. Upon regulatory approval in India, RDIF will supply Dr Reddy's 100 million doses of the vaccine, the firm had said last month. COVID-19 Vaccine Latest News Update: Anti-Coronavirus Vaccine May Be Ready by End of 2020, Says WHO Chief Tedros Adhanom Ghebreyesus.
Russia had announced in August that it has developed the world's first coronavirus vaccine, Sputnik V, without completing phase-3 trials. Besides, the phase I and II of the trials involved merely 76 participants. A vaccine is deemed safe to be commercially available only after a larger efficacy trial which involves thousands of participants in the phase-3. However, the study of Sputnik trials published in The Lancet declared the vaccine as "Safe, well-tolerated, and does not cause serious adverse events in healthy adult volunteers." (Win agencies inputs)