New Delhi: A panel of experts from the Central Standard Medicines Control Organization (CDSCO) has requested Dr. Reddy’s Laboratories to submit a revised protocol for conducting phase 2 and phase 3 human clinical trials for the Russian COVID vaccine -19, Sputnik V, in India, sources said Monday.
The Hyderabad-based pharmaceutical company had submitted an application to the Comptroller General of Medicines of India (DCGI) late last week, requesting permission to conduct phase 3 human clinical trials of the Russian vaccine.
The Subject Matter Experts Committee (SEC) on COVID-19 at CDSCO, which held its meeting on Monday, deliberated on the application and asked the firm to submit a revised protocol stating that it should conduct combined phase 2 and clinical trials. 3, sources. he told PTI.
The firm has also been asked to provide some other information.
“It means that Dr. Reddy’s laboratories will have to submit a new application. According to the SEC, they have to conduct phase 2 and 3 clinical trials and cannot directly conduct phase 3 trials for the vaccine in India,” said a source. .
The Indian pharmaceutical giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine, as well as for its distribution.
Following regulatory approval in India, RDIF will supply drugmaker Dr. Reddy’s with 100 million doses of the vaccine, the firm said last month.
According to sources, it would be a randomized, multicenter, observer-blind controlled study.
Meanwhile, sources said that the Sputnik V phase -3 trial has been underway in Russia since September 1 on around 40,000 subjects.
Sputnik V has been developed by the Gamaleya National Research Center for Epidemiology and Microbiology and RDIF.
Currently, two indigenously developed candidate vaccines, one from Bharat Biotech in collaboration with ICMR and the other from Zydus Cadila Ltd, are in phase 2 of human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca to manufacture the Oxford COVID-19 candidate vaccine, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
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