Covid-19 vaccine: Dr. Reddy’s Laboratories has been asked to reapply for the Russian vaccine to be tested in India. Experts from the Central Drugs Standard Control Organization (CDSCO) have said that revised protocols will have to be introduced for second and third stage human trials of Sputnik-V.
Dr. Reddy’s Laboratories will have to apply again
Hyderabad-based pharma company had last week sought approval from the Drug Controller General of India (DCGI) for the Phase III trial of the Russian Kovid-19 vaccine. On Monday, CDSCO’s Kovid-19 Affairs Expert Committee met to consider the application for approval. After the meeting, Dr. Reddy’s Laboratories was asked to present the revised protocol. According to sources, now in the revised protocol, it has to be told that the company will test the second and third phase simultaneously. Apart from this, the company has also been asked to provide some other information.
Russia’s Sputnik-V vaccine to be tested
It is said that applying again means the company will have to submit a new application. According to the expert committee, the company will have to do both the second and third phase of testing. In addition, the pharma company cannot directly conduct Phase III human trials in India for the vaccine. Dr. Reddy’s Laboratories has partnered with Russia’s Direct Investment Fund to conduct human trials and delivery of the Sputnik-V vaccine.
After getting regulatory approval in India, the vaccine will supply 100 million doses to Dr. Reddy’s Laboratories of Hyderabad, Russia’s direct investment fund. During this, it is being told that human trials of the third phase of Sputnik-V have been started in Russia from 1 September. The Sputnik-V vaccine has been developed jointly by Russia’s Direct Investment Fund and Gamalaya National Research Center.
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