Dr Reddy’s Laboratories, which is conducting Phase 3 trials of Russia’s COVID-19 vaccine Sputnik V, believes the jab is expected to be launched in India through Emergency Use Authorisation, a senior official of the city-based drug maker said on Friday.
“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,” company’s CEO of APIs and Pharmaceutical Services Deepak Sapra said.
In September last, Dr. Reddys partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
“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),” Mr Sapra told a press conference in Hyderabad.
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 world’s first registered vaccine against COVID-19 based on the established human adenoviral vector platform.
The Centre has already given the nod for two COVID-19 vaccines — Covaxin of city-based Bharat Biotech and Covishield of Oxford, being manufactured by Serum Institute of India in Pune, which are being administered to frontline workers from January 16.