Dr Reddy’s and RDIF receive DCGI approval for Sputnik V human trial

19 October 2020 (Last Updated October 19th, 2020 12:08)

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) have received approval from the Drug Control General of India (DCGI) to conduct a Phase II / III human trial of Sputnik V Covid-19 vaccine in India. 

Dr Reddy’s and RDIF receive DCGI approval for Sputnik V human trial
Dr Reddy’s Biopharma Finished Dosage Unit I in Hyderabad, India. Credit: Arichuvadi.

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) have received approval from the Drug Control General of India (DCGI) to conduct a Phase II / III human trial of Sputnik V Covid-19 vaccine in India.

The multi-centre, randomised and controlled trial will analyse the safety and immunogenicity of the Covid-19 vaccine candidate.

In September, Dr Reddy’s partnered with RDIF for conducting trials and supply of Sputnik V vaccine in India.

Under the deal, Dr Reddy’s will receive 100 million doses of the vaccine from RDIF for distribution in the country.

Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in August, Sputnik V derives from human adenoviral vectors platform.

On 11 August, Sputnik V vaccine was registered by the Ministry of Health of Russia, becoming the world’s first registered vaccine against Covid-19 based on this platform.

Administered in two doses, the vaccine consists of two serotypes of a human adenovirus with an S-antigen of the novel coronavirus to trigger an immune response in the body.

Dr Reddy’s Laboratories co-chairman and managing director G V Prasad said: “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.”

Presently, Sputnik V is in Phase III trial in Russia on approximately 40,000 participants.

Russian Direct Investment Fund CEO Kirill Dmitriev said: “We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian Phase III clinical trial.

“This data will further strengthen the clinical development of Sputnik V vaccine in India.”

Last week, the UAE Ministry of Health and Prevention approved Phase III trials of the Sputnik V vaccine.