Roche India on Wednesday announced that the Central Drugs Standards Control Organisation (CDSCO) has provided an Emergency Use Authorisation (EUA) for its antibody cocktail Casirivimab and Imdevimab in India.
The approval has paved the way for Roche to import the globally manufactured product batches to India.
Casirivimab and Imdevimab will be marketed and distributed in India through a strategic partnership with Cipla Limited.
This approval was based on the data that have been filed for the EUA in the United States, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
“We are working urgently to increase manufacturing capacity and supply by ramping up our own production network, as well as actively collaborating with external partners to maximise production of Actemra wherever possible with the goal of increasing its availability,” Roche said in a statement.
The Drug firm noted that with the increasing number of infections in the country, minimising hospitalisation and easing pressure on healthcare systems is particularly important.
The therapy is a cocktail of two antibodies Casirivimab and Imdevimab, which are synthetically manufactured copies of antibodies that the body produces after an infection.
It has been shown to reduce hospitalizations in COVID-19 patients who are at a high risk of developing severe illness.
The drug already has similar authorization in the United States and is used in Europe non-hospitalised patients. Former U.S. President Donald Trump had taken the drug when he contracted the disease.
Cipla said the drug is meant for people with mild-to-moderate infection who are at high risk of developing severe disease. The company did not provide a price or a launch date.