Dr Reddy’s Laboratories on Saturday said it along with Russian Direct Investment Fund (RDIF) has received approval from the Drug Control General of India (DCGI) to conduct phase 2/3 human clinical trials for Covid-19 vaccine Sputnik V in India.
This will be a multi-centre and randomised controlled study, which will include safety and immunogenicity check, the Hyderabad-based drug major said in a statement.
“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,” Dr Reddy’s Co-chairman and Managing Director GV Prasad said.
RDIF CEO Kirill Dmitriev said the entity was pleased to collaborate with the Indian regulators.
“In addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India,” he added.
Last month, Dr Reddy’s and RDIF (Russian sovereign wealth fund) had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in the country.
On August 11, the Sputnik V vaccine 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 human adenoviral vectors platform.
Sputnik V is currently undergoing phase 3 clinical trials in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week.