NEW DELHI: The Comptroller General of Medicines of India (DCGI) granted approval to Dr. Reddy`s, a global pharmaceutical company based in India, to conduct phase 2 and 3 human clinical trials of Sputnik V, a Covid-19 vaccine made by Russia.
On September 16, the Russian Direct Investment Fund (RDIF) and Dr. Reddy`s Laboratories Limited agreed to cooperate in the clinical trials and distribution of the Sputnik V Covid-19 vaccine in India.
Sputnik V, a vaccine based on adenovirus vectors, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, together with the Russian Direct Investment Fund and registered on August 11.
Dr Reddy`s Laboratories Co-Chairman and Managing Director GV Prasad said in a statement: “This is a significant advance allowing us to begin clinical trials in India and we are committed to bringing a safe and effective vaccine to combat the pandemic. .. “
“With regulatory approval in India, RDIF will supply Dr. Reddy with 100 million doses of the vaccine. The Sputnik V vaccine, which is based on a well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials. for the coronavirus pandemic, “a statement from the Russian fund had previously said.
Russia’s Direct Investment Fund had also said that deliveries could potentially begin in late 2020, provided that trials and registration of the vaccine are successfully completed by regulatory authorities in India.
“The agreement between RDIF and Dr. Reddy`s reflects the growing awareness of countries and organizations to have a diversified portfolio of anti-COVID vaccines to protect their populations,” added RDIF.
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