Dr Reddy's Laboratories announced that it has initiated process for emergency use authorization of Sputnik V vaccine.  
 
 
The drug major announced 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. 

As part of the review process, Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21 February 2021. 

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 vaccine is currently undergoing the phase 3 clinical trial in India. 

Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2,144 volunteers over 60 years old. 

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on 11 August 2020 and became the World's first registered vaccine against COVID-19 based on the human adenoviral vector platform. 

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." 

The company reported a consolidated net profit of Rs 27.90 crore in Q3 FY21 as compared to a net loss of Rs 538.40 crore in Q3 FY20. Net sales during the quarter rose 12.5% YoY to Rs 4,929.60 crore. 

Dr. Reddy's Laboratories is an integrated pharmaceutical company. Through its three businesses - pharmaceutical services & active ingredients, global generics and proprietary products – the company's offers a portfolio of products and services including APls, custom pharmaceutical services, generics, biosimilars and differentiated formulations.