According to the news published on the NDTV website, Dr. Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced the start of an adaptive phase 2/3 clinical trials for COVID-19 vaccine Sputnik V in India after receiving necessary clearance from the Central Drugs Laboratory in Himachal Pradesh. Mr. Tribhuvan Darbari, MD & CEO, Texmaco Defence Systems Private Limited and Chief Executive – Texmaco Rail & Engineering Limited congratulated the scientists and the institutions involved in the research and development. Mr. TS Darbari said that the clinical trials for the COVID-19 vaccine Sputnik V in India should be considered as another step towards boosting the Indo-Russia relationship. Mr. Tribhuvan Darbari further added that Russia is India’s most trusted partner and working closely with India in achieving industrial and technological self-reliance.
In a press release about clinical trials for COVID-19 vaccine Sputnik V in India, Dr. Reddy’s Laboratories said that it will be a multicenter and randomized controlled study, which will include a safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research as a clinical research partner. According to the news published on the website of Economic Times – India trials for Russia’s ‘Sputnik-V’ vaccine could start in the next few weeks.
Mr. Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy’s, told Reuters that Indian trials of the Sputnik-V vaccine candidate, being developed by Russia’s sovereign wealth fund, will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country.
Mr. TS Darbari said that the vaccine seems to be promising and cost-effective as per the reports. Mr. TS Darbari referred to the news published on wionews.com that mentioned, “According to the company, the vaccine is 95 percent effective and will cost less than $10 or Rs 740 internationally. Since its 2 dose vaccine, the total cost is expected to be around 1480.”
“The trials are part of a deal between the Russian Direct Investment Fund (RDIF) and Dr Reddy’s, in which the Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India. RDIF will supply 100 million doses to Dr Reddy’s.
The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India. Russia was the first country to grant regulatory approval for a novel coronavirus vaccine.”
Sources:
NDTV: Dr Reddy’s, Russian Firm RDIF Begin Clinical Trials For Covid Vaccine Sputnik V In India
Economic Times: India trials for Russia’s ‘Sputnik-V’ vaccine could start in next few weeks
wionews.com: Russia’s Sputnik V vaccine to be manufactured in India