Pharma major Cipla Limited announced the launch of Remdesivir under the brand name Cipremi. Remdesivir is the only US FDA authorized treatment for COVID19 infection.
The Drug Controller General of India has granted the medicine regulatory approval for restricted emergency use as part of the accelerated approval process considering the urgent medical need.
Cipremi is a generic version of Remdesivir, an antiviral drug first developed for treating Ebola in 2014. It is administered intravenously and inhibits viral replication in the body.
Since Remdesivir has not been approved as a treatment for COVID19 yet and has been approved by the DCGI only for “restricted emergency use”, a patient would need to sign a consent form before he is administered.
It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the union health ministry’s document on ‘Clinical Management Protocols for COVID-19’ stated.
Commenting on the launch, Umang Vohra, MD and Global CEO, Cipla said, “Cipla appreciates the strong partnership with Gilead to bring Remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by COVID-19 pandemic, and this launch is a significant milestone in that direction. We will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with our belief that no patient should be denied access to life-saving treatments.”