Cipla, Hetero get DCGI’s nod to launch Remdesivir forCovid-19 treatment
Hetero, Cipla Get Nod to Manufacture Remdesivir for Covid-19 Patients on Oxygen Support
After Glenmark being given nod by DCGI to manufacture and market favipiravir. It is for “restricted emergency use” in mild to moderate cases. Pharma giants Cipla and Hetero have been given permission to make and sell the antiviral drug Remdesivir. It is for the treatment of Covid-19 Patients on Oxygen Support.
As reported by sources to ANI, India will begin the domestic production of anti-viral drug remdesivir. It will have efficacy, stability, safety for “restricted emergency use” on Covid-19 patients. Written informed consent of each patient is required before the use of remdesivir. Results of additional clinical trials, active post-marketing surveillance data, and reporting of serious adverse events have to be submitted.
The document on ‘Clinical Management Protocols for COVID-19’ stated. remdesivir has been included as an “investigational therapy” only for restricted emergency use. It is not recommended for those with severe renal impairment. Also not for pregnant and lactating women, and those below 12 years. The drug, administered in the form of injection, should be given at a dose of 200 mg on day one. It will be followed by 100 mg daily for five days.
Cipla and Hetero Labs have entered into non-exclusive licensing agreements with US pharma giant Gilead Sciences. They are the patent holder of the drug remdesivir. Gilead Sciences had applied to the Indian Drug Regulatory Agency, CDSCO, for import and marketing of Remdesivir on May 29. After due deliberations, permission authorization was granted by DCGI on June 1.