Dr. Reddy’s Laboratories is expecting Emergency Use Authorisation from the Drugs Controller General of India (DCGI) for Russia’s COVID-19 vaccine Sputnik V in March.
“We should be in a position to launch the vaccine through EUA in March,” Deepak Sapra, CEO, API and Pharma Services, said on Friday. Phase III trials were under way. The dosing of the volunteers was expected to be completed in February post which the data will be compiled and submitted for EUA to the DCGI, he said.
The Russian Direct Investment Fund (RDIF) had announced in September a partnership with Dr. Reddy’s for clinical trials and distribution of the vaccine developed by Gamaleya National Research Institute of Epidemiology and Microbiology.
Mr. Sapra, who along with senior executives addressed media on the December quarter results of Dr. Reddy’s, denied that the company was facing challenges in recruiting volunteers for Phase III.
He said the price at which the vaccine will be supplied was yet to be discussed with the government. The plan was to provide 125 million patient doses – Sputnik is a two dose vaccine – over a period of 12 months.
“We are manufacturing Sputnik V through partners. In the initial phase, we might be also be importing some quantities of the vaccine manufactured in Russia,” he said. Dr. Reddy’s is also in discussion with RDIF to increase the scope of the agreement to export the vaccine.
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