India's First Indigenous Antibiotic Nafithromycin, To Fight AMR

04-12-2024

In November 2024, India launched its first antibiotic made within the country, Nafithromycin, to fight antimicrobial resistance (AMR), a serious health issue.
This new drug is a major progress in treating drug-resistant pneumonia, which kills over two million people each year around the world.
Nafithromycin is the first new antibiotic of its kind in over 30 years, making it a big step forward in medicine.

Why is Nafithromycin a Game-Changer?

Pneumonia is one of the leading causes of death worldwide, especially in developing countries.
However, many old antibiotics no longer work well due to antibiotic resistance, such as Azithromycin, a common treatment for pneumonia.
Nafithromycin is more powerful and effective against Community-Acquired Bacterial Pneumonia (CABP), a serious form of pneumonia caused by drug-resistant bacteria.
More Powerful and Effective:
1. Nafithromycin is 10 times stronger than Azithromycin, meaning it works much better at fighting resistant bacteria.
2. It reaches the lungs 8 times better than Azithromycin, which is important since pneumonia mainly affects the lungs.
Easier Treatment:
1. Nafithromycin requires just one dose per day for three days, making it easier for patients to follow the treatment.
2. This helps improve patient compliance, meaning patients are more likely to complete their treatment, which leads to better results.
3. Nafithromycin has very few stomach-related side effects and can be taken with or without food, making it more convenient for patients.
4. Nafithromycin has a 96.7% success rate in treating pneumonia, showing that it works well in most cases.

Why is Drug-Resistant Pneumonia a Big Problem in India?

India has 23% of the world’s pneumonia cases.
Studies show that half of pneumonia cases in India may involve bacteria that no longer respond to regular antibiotics, which is a major problem in the country.
Reasons for Resistance:
1. Overuse of Antibiotics: In India, doctors often prescribe antibiotics too easily, and people sometimes take them without medical advice.
2. This leads to bacteria becoming resistant to treatment over time.
3. Many parts of India still face problems like poor sanitation and lack of access to healthcare, making it easier for infections to spread.
4. people in India take antibiotics on their own without proper medical advice, which can cause resistance to develop.
Drug-resistant pneumonia is especially dangerous for children, the elderly, and people with weakened immune systems (such as those with diabetes or cancer).
These groups are more likely to suffer severe illness, and existing treatments may not work.

Why Nafithromycin is Important for India

Cost-Effective Treatment: Nafithromycin could lower healthcare costs by improving patient recovery and reducing the need for long hospital stays.
It also prevents the use of treatments that don’t work, which can be expensive.
Fighting AMR: As a new antibiotic, Nafithromycin can help fight the problem of antimicrobial resistance (AMR), a growing global health threat.
Developing new antibiotics is crucial in stopping the spread of infections that cannot be treated with current drugs.
Better Treatment and Faster Recovery: With its three-day treatment course, Nafithromycin allows patients to recover faster compared to other antibiotics that require longer courses. This reduces the risk of complications.

Research and Development

Years of Research: Nafithromycin is the result of 14 years of research and an investment of ₹500 crore (around $60 million).
The drug went through clinical trials in the US, Europe, and India before being approved.
Support and Manufacturing: Nafithromycin was developed with the help of the Biotechnology Industry Research Assistance Council (BIRAC), a government agency in India.
It will be sold under the brand name Miqnaf by Wockhardt Pharmaceuticals, making it available to more patients.

What is Pneumonia?

Pneumonia is an infection that causes inflammation in the lungs, affecting the air sacs (alveoli), which fill with fluid or pus, making it difficult to breathe.

Causes of Pneumonia:

Bacterial Infections: The most common cause, especially Streptococcus pneumoniae.
Viral Infections: Such as influenza (flu), respiratory syncytial virus (RSV), and coronaviruses.
Fungal Infections: Less common but can occur in people with weakened immune systems.
Aspiration Pneumonia: Caused when food, drink, or saliva is inhaled into the lungs.

Symptoms:

Cough (with or without mucus)
Fever and chills
Shortness of breath
Chest pain when breathing or coughing
Fatigue and weakness
Rapid breathing or shallow breathing
Confusion (especially in older adults)

Treatment:

Antibiotics: For bacterial pneumonia (e.g., Azithromycin, Amoxicillin).
Antivirals: For viral pneumonia (e.g., Oseltamivir for flu).
Oxygen Therapy: To improve oxygen levels in the blood.
Pain and Fever Management: With medications like acetaminophen or ibuprofen.
Hospitalization: In severe cases, especially for elderly or high-risk patients.

What is Antimicrobial Resistance (AMR) and Growing Threats:

One of the most pressing concerns in global health today is Antimicrobial Resistance (AMR).
AMR occurs when harmful germs, such as bacteria, fungi, and viruses, evolve to resist the effects of medicines like antibiotics.
This makes infections harder to treat, leading to longer hospital stays, increased medical costs, and even death.
Overuse and misuse of antibiotics are key drivers of AMR, particularly in regions like South and Southeast Asia.
These regions account for 6.5% of global antibiotic use, with a disproportionate share of critical antibiotics that are essential for treating severe infections.
A major contributor to AMR is the under-vaccination of children.
When children are not vaccinated, they are more likely to contract preventable diseases, leading to unnecessary antibiotic use.
This misuse of antibiotics accelerates the development of resistant bacteria, making it more difficult to treat common infections.

One powerful example shared during AMR Week is the tragic story of Felix Liauw from Indonesia.

He lost his 3-month-old son due to a misdiagnosis and the inappropriate use of antibiotics.
His son was wrongly treated for sepsis, even though he had a rare condition called congenital short bowel syndrome.
This case shows the importance of proper diagnosis and responsible antibiotic use to avoid life-threatening consequences.

How can AMR be prevented?

Increased Vaccination: Reduction in Antibiotic Use:

By preventing infections that would otherwise require antibiotics, vaccines would help reduce the overall antibiotic consumption.
This reduction is crucial in the fight against AMR, as overuse of antibiotics is one of the main drivers of resistance.

The study also suggested that the greatest reductions in antibiotic use would be observed in economically advantaged groups, though even economically disadvantaged populations would experience benefits, leading to a more equitable reduction in antibiotic consumption.