Dr Reddys seeks Indian regulatory nod for Sputnik M vaccine for adolescents
Hyderabad: Dr Reddy's Laboratories on Friday said it is in discussions with the Indian drug regulator to bring Russia's Sputnik M, a COVID-19 vaccine for the 12 to 18-year-old category, to India.
Addressing a press conference after announcing the company's Q3 results, a senior executive of the drug maker said Phase 3 clinical trial data of Russia's single dose COVID-19 vaccine Sputnik Light has been submitted to the regulator and is awaiting approval.
Deepak Sapra CEO – API and Services Dr. Reddy's, also said the company is fully geared to make Molnupiravir, a COVID-19 drug both API and Formulations, at its facilities, even as it approached World Health organization for the prequalification of the drug.
"Sputnik M is a sputnik for adolescents. In Russia, Sputnik M has been given the approval by the regulator for children in the 12 to 18 years old group. The same data has been made available here. We are in the process of translating the data and we will be having a conversation with the regulator on this data within the next few months," Sapra told reporters.
He further said the company may probably conduct another round of clinical trials in India if the Indian regulator says so.
Russian Direct Investment Fund (RDIF) last month said it has applied for the registration of Sputnik M, to the Indian regulator for approval. The sovereign wealth fund said Russia's Health Ministry registered Sputnik M on November 24, 2021.
Replying to query, he said the clinical trials for the Sputnik Light in India are over and the data was submitted to the Drug Controller General of India.
"It has demonstrated efficacy which is consistent and in line with the result that we have seen in the global trials which we have conducted in Russia. What we conducted in India is safety and immunogenicity studies," Sapra said.
On Molnupiravir, the official said in this current wave Omicron is the dominant variant and it has seen relatively lower hospitalizations. However, the company will continue to be ready for the COVID-19 drug to be made available for India and 103 countries for which it has rights.
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