October 8, 2020: The Drugs Controller General of India has declined the proposal of pharma company Dr Reddy’s laboratories to conduct the third phase trial of Russia’s Sputnik V vaccine as the early trials have been conducted on a small group of overseas population.
Recommendations by an expert panel of the Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.
“After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct phase 2/3 trial in the country with proper monitoring for humoral and cell mediated immune response,” the committee that looked into Dr Reddy’s proposal said.
India's move comes as a setback for Russia's plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.
After Russia became the first country that claimed to have come up with an effective COVID-19 vaccine, Dr Reddy’s Lab joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
The phase-3 trial of Sputnik V is underway in Russia on around 40,000 subjects since September 1.
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October 8, 2020: The Drugs Controller General of India has declined the proposal of pharma company Dr Reddy’s laboratories to conduct the third phase trial of Russia’s Sputnik V vaccine
October 8, 2020: The Drugs Controller General of India has declined the proposal of pharma company Dr Reddy’s laboratories to conduct the third phase trial of Russia’s Sputnik V vaccine as the early trials have been conducted on a small group of overseas population.
Recommendations by an expert panel of the Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.
“After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct phase 2/3 trial in the country with proper monitoring for humoral and cell mediated immune response,” the committee that looked into Dr Reddy’s proposal said.
India's move comes as a setback for Russia's plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.
After Russia became the first country that claimed to have come up with an effective COVID-19 vaccine, Dr Reddy’s Lab joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
The phase-3 trial of Sputnik V is underway in Russia on around 40,000 subjects since September 1.