The Drug controller of India (DCGI) given the approval for Mylan Remdesivir Lyophilized powder for injection under the brand name of DESREM for restricted emergency use in COVID -19 patients in India
Desrem (Remdesivir) 100mg / vial with MRP Rs. 4800 per injections, may be available in the market during the July month middle or end.
Desrem (Remdesivir) will be manufacture by Mylan in its injection manufacturing facilites in India.
Remdesivir is an investigational drug targeted for COVID-19 and has demonstrated favorable outcomes in two P-III trials. Additionally, the US FDA granted EUA to treat hospitalized patients with severe COVID-19 based on the two P-III trials results in the US also recommended for compassionate use in EU including Japan, Taiwan, and Singapore
Mylan's version Desrem (Remdesivir) is the third company got the approval for Remdesivir already Hetero Labs Covifor (Remdesivir) and Cipremi (Remdesivir) Cipla Ltd launched their generic versions of the drug.
Cipla will price its version, Cipremi at Rs. 4,000, while Hetero has priced its version Covifor at Rs.5,400.
Gilead has signed licensing agreements with India's Dr. Reddy's Laboratories Ltd, Jubilant Life Sciences Ltd, Syngene International Ltd and Zydus Cadila, listed as Cadila Healthcare Ltd, to make and sell remdesivir.
The Union Health Ministry of India ,on Friday has revised the dosage of the antiviral drug - remdesivir, being administered to hospitalized Covid-19 patients from the earlier six-days to five-day treatment course.
According to the Health Ministry, remdesivir drug is only for restricted emergency use on patients with moderate disease (those on oxygen support). The drug cannot be administered to a pregnant or lactating mother and children below the age of 12 years. Also, the drug is not recommended to a patient with severe renal impairment and a high level of liver enzymes.
The Central Health Ministry has issued a fresh clinical management protocol for COVID-19 patients on Friday. In the latest protocol, the ministry has informed the dosage of remdesivir should be 200 mg IV on day 1 followed by 100 mg IV daily for 4 days (5 days in total). However, in the previous clinical protocol issued on June 13, the Health Ministry stated that the patient has to be administered with 200 mg IV on day 1 followed by 100 mg IV daily for 5 days, that was, 6 days in total