The city-based drug maker said in a press release that this will be a multi-center and randomised controlled study, which will include safety and immunogenicity study.
GV Prasad, co-chairman and MD, DRL, 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.” (AP Photo)Dr Reddy’s Laboratories and Russian Direct Investment Fund on Saturday announced that they have received approval from the Drug Control General of India to conduct an adaptive phase 2/3 human clinical trial for Sputnik vaccine in India. The city-based drug maker said in a press release that this will be a multi-center and randomised controlled study, which will include safety and immunogenicity study.
GV Prasad, co-chairman and MD, DRL, 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.”
Kirill Dmitriev, CEO of RDIF, 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 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India.”
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