Dr Reddy's seeks approval for 3rd stage Human Trials from DCGI : Russian Sputnik V vaccine


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▴ Dr Reddy's seeks approval for 3rd stage Human Trials from DCGI : Russian Sputnik V vaccine
Dr Reddy's is the official partner for the Russian vaccine in India

Indian pharma giant Dr Reddy's Laboratories on Friday applied to the Drugs Controller General of India (DCGI) for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against coronavirus in India.

The Hyderabad-based giant has collaborated with the Russian Direct Investment Fund (RDIF) in order to conduct clinical trials of Sputnik V as well as its distribution.

After approval in India, the firm has said that RDIF will supply to Dr Reddy's 100 million doses of the vaccine.

"Dr Reddy's Laboratories has applied to the DCGI seeking permission to conduct phase-3 human clinical trials of the Sputnik V vaccine against COVID-19 developed by Russia. The DCGI will carry out a technical evaluation of the application before giving its approval," a source said.

The phase-3 trial of Covid vaccine Sputnik V is underway in Russia since September 1 on nearly 40,000 subjects, source added.

Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF in Russia have developed Sputnik V.

In India currently two vaccine candidates - Bharat Biotech in collaboration with ICMR and the one developed by Zydus Cadila Ltd - are in phase 2 of human clinical trials, PTI reported.

Meanwhile, India has sustained its trend of maintaining the active cases below the 10 lakh mark. For the 10th successive day, the active cases are less than 1 million (10 lakhs). With a very high number of COVID patients recovering every single day, India’s steady trend of posting a high level of daily recoveries also continues. 85,376 recoveries have been registered in the last 24 hours in the country. India’s total recoveries stand at 52,73,201 today.

A higher number of single-day recoveries have resulted in a continuous increase in the national recovery rate, which is currently pegged at 83.53%. The rise in total recovered cases has been steep. The last 10 lakh recoveries were added in just 12 days. 77% of the total recovered cases are recorded in 10 States/UTs. Maharashtra has contributed the highest number to the total recovered cases followed by Andhra Pradesh and Tamil Nadu. The active cases in India are 9,40,705. India reported 9.4 lakh active cases earlier on 11th September 2020. 76% of the active cases are in 10 States/UTs. As on date, the active cases contribute only 14.90% to the positive caseload of the country. A total of 86,821 new confirmed cases have been reported in the last 24 hours in the country. 76% of the new cases are concentrated in ten states. Maharashtra contributed more than 18,000 to the new cases. Karnataka and Kerala, both contributed more than 8,000. 1,181 deaths have been registered in the past 24 hours. 82% of new deaths are reported from 10 States and UTs. 40% of deaths reported yesterday are from Maharashtra with 481 deaths followed by Karnataka with 87 deaths.

Inputs - PTI

Tags : #DrReddys #RussianSputnikVaccine #RDIF #LatestVaccineNewsIndiaNov3 #GamelayaResearchCentre

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