Antibiotic breakthrough from India can counter drug-resistant bacteria

India has launched the first indigenous antibiotic for drug-resistant infections. Known as ‘Nafithromycin,’ the drug has been developed by researchers from the Biotechnology Industry Research Assistance Council (BIRAC), a unit of the Department of Biotechnology of India.
Nafithromycin, which will be used in the treatment of drug-resistant community-acquired bacterial pneumonia (CABP) in adults, will soon be available on the market under the brand name “Miqnaf”, distributed by the Mumbai-based pharmaceutical company Wolkardt.
In the race to create replacement antibiotics and antifungals, the soft launch of Nafithromycin is a step forward in combating the silent pandemic – Antimicrobial Resistance (AMR).
Every year, drug-resistant pneumonia causes over two million deaths worldwide. India, accounting for 23% of the global community pneumonia cases, struggles with treatment challenges, including rising resistance to drugs like azithromycin.
For years, azithromycin has been the first-line treatment for pneumonia since it targets the microbes responsible for the development of the disease. It is given to adults at a 500mg dosage for three to 10 days. Depending on the severity of the condition, a higher dosage may be prescribed.

The soft launch of Nafithromycin is a step forward in combating the antimicrobial resistance. (Photo: Getty Images)

However, with increasing resistance to azithromycin, the drug failed to work on my patients. With Nafithromycin’s introduction, experts believe, it could provide a “much-needed relief” against resistant pathogens.
ALL ABOUT NAFITHROMYCIN
Nafithromycin is the first new antibiotic in its class developed worldwide in over 30 years. It is a novel semi-synthetic macrolide antibiotic designed to combat multiple drug-resistant bacteria effectively.
Its unique feature is its ultra-short, once-daily, three-day therapy, enabled by its ability to remain in the lungs for extended periods. This comes at a critical time when antimicrobial resistance (AMR) is becoming a global health crisis, with few new treatments available.
Nafithromycin is 10 times more efficacious and provides eight times higher lung exposure than azithromycin. It boasts superior safety and tolerability and even has a clinical cure rate of 96.7%.
Developed in India after 14 years of research and an investment of Rs 500 crores, Nafithromycin is designed to tackle multi-drug-resistant pathogens.

Nafithromycin is 10 times more efficacious and provides eight times higher lung exposure than azithromycin. (Photo: Getty Images)

What makes Nafithromycin remarkable is its ability to target both typical and atypical bacteria, overcoming resistance mechanisms that have rendered other antibiotics less effective.
Clinical trials conducted in the US, Europe, and India show it is ten times more effective than azithromycin and works with just a three-day course.
It’s also safe, with minimal side effects, no major drug interactions, and can be taken with or without food, making it a convenient option for patients.
Union Minister Dr. Jitendra Singh announced that the drug is awaiting final approval from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing and public use.
WHAT DOES IT MEAN FOR INDIA?
Drug-resistant pneumonia has faced significant treatment hurdles, often leading to prolonged hospital stays and increased mortality.
Nafithromycin’s once-a-day, three-day regimen simplifies treatment, ensuring better compliance and reducing the risk of antibiotic misuse. Drug-resistant pathogens are those bacteria that do not respond to any drugs. In the case of pneumonia, most patients stopped responding to azithromycin.
“I am optimistic about Nafithromycin’s potential to save lives and improve patient care in the battle against antibiotic resistance. Its targeted action against resistant pathogens brings much-needed relief, particularly in India, where respiratory infections are a major concern,” Dr. Sulaiman Ladhani, Pulmonologist at Wockhardt Hospitals, Mumbai Central told India Today Digital.

Nafithromycin is a once-a-day, three-day regimen. (Photo: Getty Images)

Dr Tushar Tayal, Consultant-Internal Medicine, CK Birla Hospital, Gurugram, told India Today Digital that common infections like pneumonia, tuberculosis, and urinary tract infections become increasingly difficult to treat, often requiring longer and more expensive medical interventions.
“In severe cases, infections caused by resistant bacteria lead to higher mortality rates. Antibiotic resistance also jeopardises medical procedures that rely on effective antibiotics, such as surgery and cancer treatments,” he said.
Since Nafithromycin is Indian-made, the drug will become affordable and easily accessible for treatment.
However, Dr Ladhani cautioned against misuse and overuse of the drug.
“While Nafithromycin holds immense promise, it’s important to use it judiciously to prevent the emergence of further resistance. We do need continued research and surveillance to monitor its effectiveness and potential side effects in the long-run,” said Dr Ladhani.
Dr Mayank Saxena, Additional Director, Pulmonology, Fortis Hospital, Noida, said that although its a new antibiotic, clinicians will continue using traditional medicines, before the jump to Nafithromycin is made.
“I feel, we will be using Nafithromycin, as per guidelines, but still we have to use the conventional medicines. Only when we don’t see any response in the patient that is when we will have to prescribe Nafithromycin to test the efficacy,” said Dr Saxena.