Indian makers of Sputnik V may seek waiver for local Phase-3 trials
Five of six Indian companies that have entered into manufacturing arrangements with sovereign fund Russian Direct Investment Fund (RDIF) for Covid-19 vaccine Sputnik V may seek a waiver of conducting local Phase-3 clinical trials.
One of the six, Hetero Biopharma, had last fortnight obtained clearance from the subject expert committee under India’s drug controller to conduct Phase-3 trials of the Russia-developed vaccine in India.
Sauri Gudlavalleti, head of research and development at Dr Reddy’s Laboratories, which has secured rights to distribute Sputnik V and obtained emergency authorisation in India, said the other five may approach the Indian regulator shortly seeking the exemption.
Read m“It is a technology transfer and not a redevelopment,” said Sauri, citing that as a reason to seek the waiver. He was responding to media queries on the sidelines of a programme on Monday to announce Dr Reddy’s arrangement with Apollo Hospitals for administering the vaccine in 35 Indian cities.
Dr Reddy’s is initially importing Sputnik V and has priced it at Rs 995.40 a dose inclusive of GST. Apollo will charge Rs 1,250 a dose, including the vaccine administration cost.
On Hetero Biopharma seeking to conduct Phase-3 trials, Sauri said: “That is one approach that has been taken. But we will have to see depending on the regulatory approach and pathway to be taken by the rest.”
Source: Economic Times