THD NewsDesk, Telangana: On 22 September, an executive at the Dr. Reddy’s Laboratories Ltd disclosed that it is likely to begin late-stage Indian clinical trials of Russia’s ‘Sputnik-V’ soon. Dr. Reddy’s Laboratories is an Indian multinational pharmaceutical company located in Hyderabad.
Sputnik V is the trade name of the vaccine candidate developed by Russia’s Gamaleya Research Institute of Epidemiology and Microbiology. The vaccine was registered on 11 August 2020 by the Russian Ministry of Health and was funded by Russian sovereign’s wealth.
The clinical trials of Russia’s COVID-19 vaccine candidate would recruit 1,000-2,000 participants to determine the efficacy of the vaccine. The research trials would be conducted at several hospitals situated across India, both private and government ones, according to Deepak Sapra, CEO for API and pharmaceutical services at Dr Reddy’s Laboratories.
“We want to get to the first step – which is the commencement of the clinical trials by getting the necessary approvals from the Indian regulators – within the next few weeks,” Sapra said.
The trials were finalized through an agreement between the Russian Direct Investment Fund (RDIF) and Dr. Reddy’s that made RDIF bound to supply 100 million doses to the drug manufacturer. Dr. Reddy’s firm is now authorized to perform the Phase III studies in India and seek regulatory approvals from the government. If approved, the Indian firm will receive the permit to distribute the finished vaccine product in India.
The Sputnik-V doses in all likelihood would be a hybrid of Indian- and Russian-made doses, Sapra said in a statement. The delivery of vaccine doses pledged to be supplied in India are promised to be supplied by late 2020. However, there is a possibility the supply could reach India later than expected, due to long-drawn procedural formalities.
Moreover, the RDIF has struck a deal with Indian drug firms to manufacture 300 million doses of the shot in India. This contract made Russia the first country to grant regulatory approval for a novel coronavirus vaccine.
Currently, India is one of the world’s worst-affected country by the Covid-19 pandemic. The coronavirus curve rate displays no signs of flattening for India. Our country has the largest number of coronavirus case-load, which is only second to the United States. The reported figure of the highest daily spike in confirmed infections in India is alarming. The total number cases since the wave of coronavirus hit India touched 5.6 million in September and if an effective vaccine is not developed soon, India’s population would be under great threat.
