COVID-19 Vaccine: DCGI allows Dr Reddy's Lab to conduct trials of Sputnik V

The Drugs Controller General of India (DCGI) permitted Dr Reddy's Laboratories to conduct phase 2 and phase 3 clinical trials of Russia's COVID-19 vaccine Sputnik V. This came just days after DCGI denied permission to Dr Reddy's Laboratories for the large scale study for testing the Russian vaccine in India while asking it to examine Sputnik V in a smaller trial. Dr Reddy's Laboratories is collaborating with the Russian Direct Investment Fund (RDIF) for the trials and distribution of Sputnik V in India. 

DCGI permits Sputnik V trials

Earlier, Dr Reddy's lab submitted an application to DCGI seeking permission to conduct a phase 3 clinical human trials for the Russian COVID-19 vaccine, Sputnik V. The drugs regulator conducted a technical evaluation of the application before giving permission to the pharmaceutical company. According to the officials, the clinical trials of COVID-19 vaccine Sputnik V will be multi-centre, observer-blind and randomised controlled study and the primary focus of the study will be on safety and immunogenicity of the vaccine. According to ANI, Russia had promised to supply 100 million doses of Sputnik V to Dr Reddy's Laboratories after receiving approval from DCGI. RDIF CEO Kirill Dmitriev further informed that Russia is in discussion with the Indian government for the localised production of Sputnik V in the country. 

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Before India, Belarus and UAE gave approval for the human trials of Sputnik V. Just a few days ago, the UAE Ministry of Health and Prevention gave the approval for Phase III clinical trials of the Russian vaccine becoming the second country after Belarus to take part in the programme. The trials will be supervised by the Abu Dhabi Department of Health and the UAE Ministry of Health and Prevention and the medical protocols will be handled by a public health provider, the Abu Dhabi Health Services Company. 

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In a statement CEO of RDIF said, "As part of the Phase III trials of the Sputnik V vaccine, we are planning to expand in several other countries over the coming months, and we are delighted that the UAE will be the first country in which we do so in the Middle East."

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Russia's COVID-19 vaccine Sputnik V 

COVID vaccine Sputnik V was developed by RDIF in collaboration with the Gamaleya National Research Centre of Epidemiology and Microbiology. This vaccine became the world's first registered vaccine against COVID-19 on August 11 and is currently undergoing phase 3 trials in Russia. Researchers suggest that Sputnik V is a human adenoviral vector vaccine that fights against the COVID-19 disease. The results of phase I-II trials of Russia's vaccine were published by a medical journal The Lancet. 

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(With inputs from Agencies)