The antibody cocktail used in the Covid treatment has been approved for emergency use.
Roche India said in a statement said that the approval of the Casirivimab and Imdevimab antibody cocktail in India was based on data submitted for the EUA in the United States and the scientific opinion of the European Union's Committee for Medicinal Products for Human Use (CHMP).
For the treatment of mild to moderate Covid, an antibody cocktail can be given.
New Delhi: Roche India announced on Wednesday that the Central Drugs Standards Control Organization (CDSCO) has granted an Emergency Use Authorization (EUA) for Roche's investigational antibody cocktail for the treatment of COVID-19.
Roche India said in a statement that the approval of the Casirivimab and Imdevimab antibody cocktail in India was based on data submitted for the EUA in the United States and the scientific opinion of the European Union's Committee for Medicinal Products for Human Use (CHMP).
"This Emergency Use Authorization will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited," it added.
According to the statement, the antibody cocktail will be used to treat mild to moderate coronavirus disease in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who have been reported to have SARS-COV2 infection and are at high risk of developing serious COVID-19 disease.
It may be able to support these high-risk patients dramatically until their condition worsens, according to the report.
"With the increasing number of COVID-19 infections in India, Roche is committed to doing everything we can to minimize hospitalizations and ease pressure on healthcare systems," Roche Pharma India MD V Simpson Emmanuel told a news portal.
It goes on to say that neutralizing antibody cocktails like Casirivimab and Imdevimab will help combat COVID-19 and treat high-risk patients until their condition worsens.
Cipla MD and Global CEO Umang Vohra said, "This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of ''Caring for Life''.
Cipla will market and distribute the commodity in India, using its extensive distribution network.
According to Roche India, the drug will be available at leading hospitals and COVID treatment centres.