Instant Report

Date: 29-Jul-2021

Apex Labs Receive Regulatory Approval For Oral Antiviral Clevira Tablets

Apex Laboratories Private Limited, a Chennai based pharmaceutical manufacturer and exporter known for research, innovation and quality medicines for more than four decades, has received approval from Government of India (Ministry of Ayush) regulators for their anti-viral drug Clevira as an additional indication as a supporting measure for mild to moderate condition of Covid-19.

This is the 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 brainchild of Apex's R&D Centre based on proven scientific evidence and was launched in Indian market aftermath of Dengue outbreak 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. Clevira is an approved antiviral formulation for the treatment of various viral infections including viral fever associated with or without thrombocytopenia.

Clevira has proven for its efficacy as analgesic, antipyretic and reversal of thrombocytopenia apart from its antiviral property. Clevira has ten potent standardized extracts, many of them antiviral in nature, including papaya leaf extract. Clevira is safe on host and lethal on viral cells. Studies indicate it doesn’t have any adverse reactions on vital organs. It is found to be very safe on renal and hepatic parameters. The results from clinical trials concluded in the month of September 2019, were published in an international journal called, International Journal of Innovative Research in Medical Sciences.

A phase III clinical trial was carried out in Government Medical College, Omandurar Government Estate Chennai, based on Government approval from The State Government of Tamil Nadu. The trial outcomes revealed Clevira having 86% recovery rate on 5th day of treatment in mild to moderate Covid-19 and 100% recovery rate noticed on 10th day of treatment, as per RT PCR or CT values. Clinical recovery from all signs and symptoms registered on 4.1 days. Clevira is proven to be safe on Kidney and Liver parameters.

The study outcomes were placed before the Government of Tamil Nadu, Indian Council of Medical Research (ICMR) and Ministry of Ayush in 2020. After various stages of scrutiny and deliberations before various technical review committees, Government of India (Ministry of Ayush) regulators have granted approval for Clevira as a supporting measure for mild to moderate condition of Covid-19.

Clevira is effective when taken orally and the dosage is one tablet twice daily after food for 14 days. Clevira is available as tablet and in syrup form too. Clevira is cost effective, the cost of entire therapy is less than Rs. 500/-, each tablet of Clevira costs only Rs. 11/- and not a financial burden in a country like ours. It has excellent proven safety profile and can be co-prescribed with patients of other co-morbidity conditions; it is also safe for kids above two years. It can be given as a prophylactic for frontline workers.