In a ground breaking step for India’s biotechnology sector, Union Minister Dr. Jitendra Singh has formally launched the first indigenous antibiotic ‘Nafithromycin’ for resistant infections at an event here.
The drug is now awaiting final approval from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and public use, marking a major leap forward in India’s fight against AMR.
The antibiotic has been developed with the support of "Biotechnology Industry Research Assistance Council" (BIRAC), a unit of the Department of Biotechnology and has been brought to market under the trade name "Miqnaf" by pharma company "Wolkardt".
It is the country's first indigenously developed antibiotic aimed at tackling Antimicrobial Resistance (AMR).
This innovation is designed to treat Community-Acquired Bacterial Pneumonia (CABP), a severe illness caused by drug-resistant bacteria, which disproportionately affects vulnerable populations, including children and the elderly as well as immune compromised hosts like Patients with Diabetes, Cancers etc, said the Minister, as per a statement here.
Dr. Singh described the three-day treatment regimen of Nafithromycin as a game-changer in addressing drug-resistant pneumonia, a condition responsible for over two million deaths globally each year.
India, which bears 23% of the world’s community pneumonia burden, faces challenges with existing treatments, including widespread resistance to drugs like azithromycin. The new antibiotic is said to be ten times more effective than current options and offers a safer, faster, and more tolerable solution for patients.
Nafithromycin’s efficacy stands out as it targets both typical and atypical pathogens, offering a potent solution where no new antibiotic in this class has been developed worldwide for over three decades.
Beyond its efficacy, Nafithromycin boasts superior safety and tolerability. The antibiotic has minimal gastrointestinal side effects, no significant drug interactions, and remains unaffected by food, making it a versatile option for patients.
The antibiotics marks a historic breakthrough as the first new antibiotic in its class to be developed globally in over 30 years. “This significant milestone comes at a time when antimicrobial resistance (AMR) is a growing global health crisis, with few new drugs entering the pipeline,” said the Minister.
The development of Nafithromycin is a testament to India’s scientific advancement, offering a much-needed solution to combat multi-drug-resistant pathogens. Its innovative design, targeting both typical and atypical organisms and its ability to overcome existing resistance mechanisms, positions it as a beacon of hope in the fight against AMR, with the potential to save countless lives worldwide.
