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The Uttar Pradesh government has given permission to Bharat Biotech International Limited for the third phase clinical trial of COVID-19 vaccine COVAXIN in Lucknow and Gorakhpur.
Additional Chief Secretary (Health) Amit Mohan Prasad in his order on Wednesday said that Sanjay Gandhi Post-Graduate Institute of Medical Sciences (SGPGI) Director Dr RK Dhiman would be the nodal official for Lucknow and BRD Medical College Principal Dr Ganesh Kumar would be the nodal officer for Gorakhpur.
The approval letter sent to Bharat Biotech Director Dr V Krishna Mohan says: “Refer to your letter dated September 19, 2020 addressed to the undersigned requesting for permission to seek approval and facilitation to initiate COVAXIN TM Phase 3 Efficacy and Safety clinical trial in Uttar Pradesh.
“I am pleased to inform you that after due consideration, it has been decided to allow Bharat Biotech to conduct phase 3 trial in Lucknow and Gorakhpur respectively.”
Prasad said all required approvals would have to be obtained by the company and all safety and other protocols would have to be followed as per the guidelines of the Government of India for conducting clinical trials.