An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has asked Dr Reddy’s Laboratories to submit a revised protocol for conducting both phase 2 and phase 3 human clinical trials for the Russian vaccine against COVID-19, Sputnik V, in India, a government official said Monday.
The Indian drugmaker has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
Last week, Dr Reddy’s Lab had applied to the Drugs Controller General of India (DCGI), seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.
“The Subject Expert Committee (SEC) had a thorough evaluation of the application submitted by Dr Reddy’s lab. The SEC has sought revised protocol from Dr Reddy’s lab along with more information and now Dr Reddy’s lab has to furnish a fresh protocol to the DCGI,” the official stated.
The firm has been asked to provide some other information as well.
As per RDIF, it will supply 100 million doses of its potential Covid-19 vaccine to Indian drug company Dr Reddy’s Lab. “Before giving permission, the drug regulator will conduct a technical evaluation of the application submitted by Dr Reddy’s lab to conduct phase 2, 3 clinical trials in India of Russian covid19 vaccine,” said the official.
Upon regulatory approval in India, RDIF shall supply to drug maker Dr Reddy’s 100 million doses of the vaccine, the firm had said last month.
On August 11, the Sputnik V vaccine developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against Covid-19. Meanwhile, the phase -3 trial of Sputnik V is underway in Russia since September 1 on around 40,000 subjects.
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