DCGI approves Dr Reddy's request to conduct Phase 2, 3 clinical trials with Russia's Sputnik V COVD-19 vaccine
4 years, 5 months ago

DCGI approves Dr Reddy's request to conduct Phase 2, 3 clinical trials with Russia's Sputnik V COVD-19 vaccine

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After being denied their request to conduct a phase three clinical trial with Russia’s Sputnik V covid-19 vaccine and asked to submit a new request, the Controller General of Medicines of India has given Dr Reddy’s Laboratories its approval. After the first application was evaluated by the Subject Expert Committee on COVID-19 at Central Drugs Standard Control Organisation, the regulator said Dr Reddy’s cannot directly conduct a phase 3 trial for the COVID-19 vaccine. CDSCO had asked Dr Reddy’s to submit a revised application, which includes new protocols for both phase 2 and phase 3 human clinical trials instead of just phase 3. Kirill Dmitriev, CEO of the Russian Direct Investment Fund said in a statement, “We are delighted to be working with regulatory authorities in India and will provide data on the safety and immunogenicity of the vaccine from Phase 3 trials in Russia, in addition to data from clinical trials in India to facilitate successful Sputnik V trials in the country.” India, overlooked by Dr Reddy’s will be conducting a multicenter, randomized controlled trial, which will include safety and immunogenicity trials.

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