Russian Sputnik V trials in India to begin soon: Dr. Reddy's

New Delhi: As per reports in the media, Indian drugmaker Reddy's Laboratories Ltd could begin late-stage Indian clinical trials of Russia's potential COVID-19 vaccine named 'Sputnik V' within the next few weeks.

Deepak Sapra, CEO of API and pharmaceutical services at Dr. Reddy's, disclosed to media that India's trials will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country.

Sapra said that the clinical trials for the vaccine will likely begin after getting the necessary approvals from the Indian regulators within the next few weeks.

The trials are part of a deal between the Russian Direct Investment Fund (RDIF) and Dr. Reddy's. To keep its end of the deal, the Indian drugmakers will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the vaccine in India. As per reports, the RDIF has signed a deal to supply 100 million vaccines to the Indian firm for distribution.

Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, which is termed as the Sputnik V. The RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot in India, where the number of COVID-19 cases have continued to tick upwards.

For weeks, the country has reported the world's highest daily jump in infections, and the caseload has risen to 5.6 million as on Tuesday. India is the world's second-worst affected country by COVID-19 behind the United States.

Sapra said that RDIF and Dr. Reddy's would soon identify potential manufacturers in India. The vaccine supplied in India will likely be a combination of Indian-and Russian-made doses.

Although the RDIF has said that vaccine deliveries to India could begin in late 2020, Sapra disclosed that the process could take longer. He added that it is going to be "several months" before all the steps in the process are accomplished.

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