India's Indigenous Antibiotic to Combat AMR Highlights Pharma Progress

The arrival of nafithromycin, the nation’s initial homegrown macrolide antibiotic currently waiting for final endorsement from the Central Drugs Standard Control Organization (CDSCO), will mark a crucial moment in the battle against antimicrobial resistance, highlighting India’s expanding expertise in pharmaceutical innovation, according to the ministry of chemicals and fertilizers.

The medication created with Rs. On November 20, 2024, Union minister Dr. Jitendra Singh officially launched the Biotechnology Industry Research Assistance Council (BIRAC) Biotech Industry Programme, which includes funding of 8 crore for phase 3 clinical trials.

Created by Wockhardt with assistance from BIRAC, the medication will be sold under the name "Miqnaf," aiming at community-acquired bacterial pneumonia (CABP) due to drug-resistant bacteria, which mainly impacts vulnerable groups like children, the elderly, and individuals with weakened immune systems.

This innovative antibiotic is ten times more potent than existing therapies such as azithromycin and provides a three-day treatment course, greatly reducing recovery time while enhancing patient results. Nafithromycin is developed to target both standard and unusual drug-resistant bacteria, positioning it as an essential resource in combating the worldwide health challenge of AMR (anti-microbial resistance). "It offers enhanced safety, reduced side effects, and no major drug interactions," stated the ministry.

The development of Nafithromycin represents a significant milestone as the first novel antibiotic in its class to be launched worldwide in more than 30 years. The medication, which has participated in thorough clinical trials in the US, Europe, and India, has been created with an investment of Rs. 500 crore and is currently pending final approval from the CDSCO, the ministry stated.