Mankind Pharma, RDIF ink pact for Sputnik V sale in India
New Delhi: The Covid-19 vaccine, Sputnik V is now likely to be rolled out in India by Delhi-based Mankind Pharma apart from Dr Reddy's Laboratories, as the drugmaker has recently struck a deal with the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund for sales and distribution of the drug.
According to a recent media report in Economic Times, the announcement to this effect would be made by next week.
On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform.
In September, RDIF entered into a partnership with Dr Reddy's Laboratories to conduct clinical trials of the Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy's regulatory approval in India.
The Hyderabad-based drugmaker secured the Drug Control General of India (DCGI) nod to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine in India on October 18. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.
While Dr Reddy's and RDIF initially planned to conduct Phase 3 trials of the vaccine, but the subject expert committee (SEC) of the Central Drugs Standards Control Organization (CDSCO) which is looking into Covid related proposals asked Dr Reddy's to conduct a Phase 2 and 3 clinical trials in India, instead of just a phase 3 study.
However, it reapplied with a revised protocol, and subsequently got permission and will now start phase II and III human clinical trials involving 1,500 participants in India.
Meanwhile, RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot.
"The co-operation agreement has been signed for sales and distribution of much anticipated Covid-19 vaccine Sputnik V with RDIF by Mankind pharma," sources told ET without disclosing many details on the agreement.
Russia, the first country to grant regulatory approval for a novel coronavirus vaccine. It is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates, the daily reports.