Mankind Pharma, RDIF ink pact for Sputnik V sale in India

Also Read: Dr Reddys, RDIF Get DCGI Nod For Russian Covid Vaccine Trial

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.