Mankind pharma collaborates with Russian RDIF for distribution of Sputnik V in India

Delhi based Mankind pharma has collaborated with Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund for sales and distribution of Sputnik V in India, sources told ET.

“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 said without divulging much details on the agreement.

The announcement to this effect is likely to be made by next week, sources further said.

RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot, sources said.

Earlier in September, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of 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 upon regulatory approval in India.

Dr Reddy’s received approval from the Drug Control General of India (DCGI) on Saturday to conduct clinical trials for Sputnik V in India. 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 trial in India, instead of just a phase 3 study.

According to the SEC, the safety data in phase I/II studies was small and there was no data available on Indian subjects.

Following the approval, Dr Reddy’s will now start phase II and III human clinical trials involving 1,500 participants in India.

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.

In August this year, 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 coronavirus.

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