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Dr Reddy’s Laboratories Seeks DCGI Permission To Conduct Phase III Trials Of Russian COVID-19 Vaccine

Sputnik V vaccine developed jointly by The Russian Direct Investment Fund and the Gamaleya National Research Center of Epidemiology and Microbiology has became the world’s first registered vaccine against COVID-19

Dr Reddy's Laboratories Seeks DCGI Permission To Conduct Phase III Trials Of Russian COVID-19 Vaccine
Highlights
  • It will be a randomised controlled Phase 3 trial of Sputnik V: Researchers
  • Before permitting, the drugs regulator will conduct a technical evaluation
  • 100 million doses will be supplied to Dr Reddy's Laboratories by Russia

New Delhi: Indian pharma giant Dr Reddy’s Laboratories (DRL) has submitted an application to the Drugs Controller General of India (DCGI) for its approval to perform Phase III clinical trials of the Russian COVID-19 vaccine Sputnik V in India, a government official said on Friday. Dr Reddy’s lab had recently joined hands with The Russian Direct Investment Fund (RDIF) to conduct Sputnik V vaccine’s clinical trials as well as its distribution.
As per RDIF, it will supply 100 million doses of its potential coronavirus vaccine to the Indian pharma company.

Also Read: Health Ministry Launches Web Portal For Updates On COVID-19 Vaccine Development

Before giving permission, the drugs regulator will conduct a technical evaluation of the application submitted by Dr Reddy’s lab to conduct Phase III clinical trials in India of Russian COVID-19 vaccine, the official said.

According to officials, it would be multi-centre, observer-blind, randomised controlled study.

Last month, Kirill Dmitriev, CEO of the RDIF, said that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding localization of production of its Sputnik V vaccine here.

Also, a prestigious medical journal The Lancet has published the results of clinical trials of Phase I-II of the Russian vaccine demonstrating its safety and efficacy.

On August 11, the Sputnik V vaccine developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against the novel coronavirus.

According to Russian researchers, Sputnik V is a human adenoviral vector vaccine which fights against coronavirus disease.

Also Read: Highly Effective Coronavirus Antibodies Identified, May Lead To Passive COVID-19 Vaccine

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

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