In India, 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.
The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.

According to reports, India’s drug regulator has refused the proposal from Dr Reddy’s Laboratories Ltd to conduct a large study in the country to evaluate Russia’s Sputnik-V Covid-19 vaccine and has asked it to first test the vaccine in a smaller trial.

The reason for the setback happened after the recommendations by the expert panel of the CDSCO. They noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.

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.

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The Union Ministry of Health & Family Welfare (MoH&FW) officials are maintaining that the COVID-19 case fatality rate (CFR) is below 2% and are trying to bring it down to under 1%.

Trials for the Oxford University’s vaccine, developed in collaboration with AstraZeneca, will begin in India on Wednesday. Six volunteers will be administered doses at Pune’s Bharati Vidyapeeth medical college and hospital. This is phase-2 of the trial, as it is not mandatory to conduct phase-1 trials in India, where the vaccine’s safety is assessed.

The Center is in talks with Russia over its vaccine for Covid-19, called Sputnik-V. “As far as Sputnik-V vaccine is concerned, India and Russia are in communication. Some initial information has been shared,” Health Secretary Rajesh Bhushan said at a press conference.

Fresh guidelines for Unlock 4.0 are expected to be announced in the coming days. The Metro service in Delhi NCR, suspended since March 22 due to the pandemic, is likely to resume in September.

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