Hyderabad: Reddy Laboratory on Friday said he was discussing with Indian drug regulators to bring Sputnik M Russia, Covid-19 vaccine for category 12 to 18 years, to India.
Overcoming a press conference after announcing the results of the company Q3, a senior executive of the drug maker said clinical clinical test data phase 3 of the single dose of Russia Covid-19 Sputnik lights vaccine had been submitted to the regulator and was awaiting approval.
Deepak Sapra CEO – Fire and Services Dr.
Reddy’s, also said the company was fully directed at making Molnupiravir, Covid-19 drugs both fire and formulations, at the facility, even when approaching the World Health Organization for drug prequalification.
“Sputnik M is sputnik for teenagers.
In Russia, Sputnik M has been approved by the regulator for children in the 12 to 18-year-old group.
The same data is available here.
We are in the process of translating data and we will have a conversation with Regulators in this data in the next few months, “Sapra told reporters.
He further said the company might possibly carry out clinical trials in India if the Indian regulator said so.
Russia Direct Investment Fund (RDIF) last month said that it has submitted a registration of Sputnik M, to Indian regulators for approval.
The Sovereign Wealth Fund said the Russian health ministry registered Sputnik M on November 24, 2021.
Replying to request, he said clinical trials for sputnik light in India ended and the data was submitted to Indian drug controllers.
“It has demonstrated consistent efficacy and in line with the results we have seen in the global trial that we have done in Russia.
What we do in India is the study of safety and immunogenicity,” Sapra said.
At Molnupiravir, the official said in the omicron wave at this time was the dominant variant and had seen relatively lower hospitalization.
However, the company will continue to be ready for Covid-19 drugs available for India and 103 countries that have rights.