You are here: Home » Current Affairs » Coronavirus » News
Business Standard

Dr Reddy's gets DCGI nod to conduct Covid-19 vaccine phase 2/3 human trails

Dr Reddy's and Russian Direct Investment Fund on Saturday announced that they have received approval from DCGI to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India

Topics
Dr Reddy’s Laboratories  | Coronavirus Vaccine | Coronavirus

Press Trust of India  |  Hyderabad 

Coronavirus, vaccine, covid

: Dr.Reddys Laboratories Ltd. and

Russian Direct Investment Fund, Russias sovereign wealth 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 V vaccine in India.

The city-based drug maker said in a press release that this will bea multi-center and randomised controlled study, which willinclude safety and immunogenicity study.

Earlier in September 2020, Dr.Reddys and RDIF 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.Reddys upon regulatory approval in India.

G V Prasad, Co-chairman and Managing Director,Dr. Reddy, 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 the Russian Direct Investment Fund, 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."

On August 11, 2020, 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 worlds 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 commenced in the UAE last week.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

First Published: Sat, October 17 2020. 16:49 IST
RECOMMENDED FOR YOU