Hyderabad, Jan 29: Dr Reddys Laboratories (DRL) on Friday said it expected Russia’s COVID-19 vaccine Sputnik V, under phase 3 trials being conducted by the city-based drug maker, to be launched in India through Emergency Use Authorisation (EUA) by March this year.
The ongoing trial was expected to be completed by February after which it would approach the Drug Controller General of India (DCGI) for EUA and based on its approval the vaccine could be launched in March, DRL’s Chief Executive Officer of APIs and Pharmaceutical Services Deepak Sapra said.
DRL partnered with Russian Direct Investment Fund (RDIF) in September to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
“The phase 3 (trial) is currently ongoing. We are dosing patients and we expect to complete the dosing as part of the phase 3 by February. After that we expect to compile the data and submit for Emergency Use Authorisation, make the request to the DCGI with our dossier,” Sapra said here.
“And based on the approval from the DCGI, we believe that we should be in a position to launch the vaccine through a EUA in the month of March 2021 (in India),” he said.
Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia and became the worlds first registered vaccine against COVID-19 based on the established human adenoviral vector platform. (PTI)
