Chennai: In its fight against COVID, the Chennai-based pharma manufacturer Apex Laboratories Private Limited today said it has received the approval for Antiviral drug Clevira as a supporting measure for mild to moderate condition of COVID.
The company has received approval from the Union Ministry of AYUSH for Clevira as an additional supporting measure, makingit first of its kind approval in India through various stages of scrutiny at CCRAS (The Central Council for Research in Ayurvedic Sciences) and Inter-Disciplinary Technical Review Committee (ITRC) a 12-member technical committee constituted by Ministry of AYUSH and headed by Dr.S.K.Maulik Former Professor Department of Pharmacology AIIMS.
Clevira is the brain child of apex’s R and D Center based on proven scientific evidence and was launched in Indian market during the recent outbreak of dengue epidemic and associated mortality in 2017.
Clevira is extensively studied for its safety in animal model (Wistar rats) and efficacy in human subjects in Phase II and III clinical trials.
It is an approved antiviral formulation for treatment of various viral infections including viral fever associated with or without thrombocytopenia, besides it has proven for its efficacy as Analgesic, Antipyretic and reversal of thrombocytopenia apart from its Antiviral property, according to a release here.
A phase III Clinical trial was carried out in Government Medical College Omandurar Government Estate and the outcomes revealed that Clevira has shown 86 per cent recovery rate on fifth day of treatment in mild to moderate COVID-19.
The release said 100 per cent recovery rate was noticed on 10thday of treatment and clinical recovery from all signs and symptoms was registered in four days.
Clevira is proven to be safe on Kidney and Liver parameters.
The study outcomes were placed before the Tamil Nadu Government, Indian Council of Medical Research (ICMR) and Ministry of AYUSH in 2020.
After various stages of scrutiny and deliberations before various technical review committees, Ministry of AYUSH regulators have granted approval for Clevira as a supporting measure for mild to moderate COVID cases.
Clevira is effective when taken orally and the dosage is one tablet twice daily after food for 14 days. (UNI)
