Indian pharmaceutical major Dr Reddy's on Friday (20 February) announced that it has approached Drug Controller General of India (DCGI) for emergency approval of Russian Covid-19 vaccine candidate, Sputnik V, in India.
In a statement, the company said that it has "initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V".
The Sputnik V, if cleared by the DCGI, will be the third vaccine, after Serum Institute's Covishield and Bharat Biotech's Covaxin, to receive regulatory nod for emergency use in India.
As part of the review process, Dr Reddy's said it will present the safety profile of the phase 2 study conducted on Sputnik V as well as interim data of its ongoing phase 3 study, which the company expects to complete by 21 February.
In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India.
The Hyderabad-headquartered firm began testing the vaccine, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology, in India on around 1,500 participants last December, reports Indian Express.
In January, Dr Reddy's said that it had received the green light to progress from phase 2 trials to phase 3 testing. The trials in India aim to prove Sputnik V’s ability to provide protection in the Indian population.
G V Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories said, “The efficacy of Sputnik V was reported to be 91.6 % by the Lancet, which is an impressive development in the fight against COVID-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India.”
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