Dr Reddy's gets DCGI nod to conduct Sputnik clinical trials for Sputnik V vaccine in India

New Delhi: Dr Reddy's Laboratories Ltd and Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, on Saturday announced that they have received approval from the Drug Control General of India (DCGI) to conduct late-stage clinical trials for Sputnik V vaccine in India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.

Earlier in September 2020, 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 and RDIF initially planned to conduct only a phase 3 trial of the vaccine, but the subject expert committee (SEC) of the Central Drugs Standards Control Organization (CDSCO) asked Dr Reddy's to conduct a seamless Phase 2 and 3 clinical trial in India, instead of just a phase 3 study, because the safety and immunogenicity data in overseas phase I/II studies was small and there was no data available on Indian subjects.

Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday. Dr Reddy's co-chairman and MD G V Prasad said: "This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic."