Dr Reddy’s Laboratories has been asked to resubmit the protocol for conducting phase 2 and 3 human clinical trials of the Russian vaccine candidate, Sputnik V, in India. The Hyderabad-based Dr Reddy’s Laboratories had earlier sought permission from the Drugs Controller General of India (DCGI) to conduct the phase-3 trials in India.
An expert panel of the Central Drugs Standard Control Organisation (CDSCO) asked Dr Reddy’s to submit a revised protocol for conducting human clinical trials, sources told news agency PTI.
The decision was likely taken by the Subject Expert Committee (SEC) on COVID-19 at the CDSCO meeting held on October 5.
Also Read: Dr Reddy’s seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine Sputnik V
The drug maker has been asked to provide some additional information.
“Dr Reddy’s laboratories will have to submit a new application. According to the SEC, the firm will have to conduct both phase-2 and 3 clinical trials and cannot directly conduct the phase-3 trial in India,” a source told PTI.
Dr Reddy’s Laboratories has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V vaccine, as well as for its distribution.
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Upon regulatory approval in India, RDIF shall supply to drug maker Dr Reddy’s 100 million doses of the vaccine, the firm had said last month.
The phase-3 trial of Sputnik V is currently underway in Russia since September 1 on around 40,000 subjects.
Russia will also begin Phase 3 trials of a second potential vaccine against COVID-19, developed by Siberia’s Vector Institute, in November-December.
Sputnik V has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF.
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At present, two indigenously developed vaccine candidates, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd, are in phase 2 of the human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials of the candidate in India.
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