Nafithromycin stands out as a groundbreaking achievement in India’s pharmaceutical landscape, being one of the first antibiotics developed within the country. As a member of the macrolide antibiotic class, it has demonstrated significant potential in combating various bacterial infections.
This milestone underscores India’s advancing capabilities in pharmaceutical research and development and plays a vital role in the global battle against antibiotic resistance. By fostering the creation of homegrown antibiotics like Nafithromycin, we can ensure a reliable supply of effective treatments while decreasing dependency on imports, ultimately enhancing public health and safety.
Nafithromycin the Answer to Antibiotic Resistance
Antimicrobial resistance has long been a significant global issue, with pharmaceutical companies working diligently to develop new medicines to combat it worldwide. After years of facing challenges and putting in relentless effort, a breakthrough has finally been achieved. After three decades of research and hard work, India has pioneered the creation of Nafithromycin, the country’s first indigenous macrolide antibiotic. This significant achievement represents a crucial moment in the battle against antimicrobial resistance, highlighting India’s enhanced capabilities in pharmaceutical innovation.
What is Antimicrobial resistance?
Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi, or parasites evolve to resist the effects of medications designed to kill or inhibit them, such as antibiotics, antivirals, antifungals, and antiparasitics. This makes standard treatments ineffective, leading to persistent infections and increasing the risk of spread, severe illness, and death.
Antimicrobial resistance (AMR) is a natural process caused by genetic changes in pathogens over time. However, human activities significantly accelerate its spread, especially the overuse and misuse of antimicrobial drugs in humans, animals, and plants. Antimicrobial resistance (AMR) is a significant global health concern, resulting in approximately 600,000 deaths in India annually due to resistant infections.
Nafithromycin is ten times more effective than Azithromycin
Nafithromycin is a ten times more effective antibiotic than current treatments like Azithromycin and provides a three-day treatment regimen. Thus it significantly shortens the recovery time while improving patient outcomes.
Nafithromycin is intended to treat both typical and atypical drug-resistant bacteria. Thus making it an essential tool in combating the global health crisis of antimicrobial resistance (AMR). It offers enhanced safety, minimal side effects, and no major drug interactions.
Nafithromycin marks a historic milestone as the first new antibiotic in its class introduced globally in over 30 years. The drug has undergone extensive clinical trials in the U.S., Europe, and India.
Breaking Barriers: The Story Behind Nafithromycin, India’s First Antibiotic
Developing new antimicrobials is challenging, time-consuming, and often not financially viable for pharmaceutical companies. As resistance grows, our arsenal of effective drugs is shrinking.
Nafithromycin has been developed with an investment of ₹500 crores. It has been developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council.
Nafithromycin was officially launched by Union Minister Dr. Jitendra Singh on November 20, 2024. Nafithromycin is sold under the brand name “Miqnaf”. Furthermore, it targets community-acquired bacterial pneumonia (CABP) caused by drug-resistant bacteria. Moreover, drug resistance disproportionately affects vulnerable populations, including children, older people, and individuals with compromised immune systems.
Besides developing Nafithromycin, the Government of India has undertaken significant actions to fight Antimicrobial Resistance (AMR) through various strategic initiatives focused on surveillance, awareness, and collaboration. These initiatives aim to strengthen AMR containment, enhance infection control, and promote global cooperation.
Combination medicine combines two or more salts into single-dose tablets or capsules. They are also called as fixed-dose combination drugs. Now the government has taken steps to ban combination medicine. Furthermore, the Government of India has banned 156 medicines. These include especially skin care, pain relievers, multivitamins and other medicines.
Generally, these medicines are found in homes. According to the government notification, these medicines can threaten humans. Safer alternatives are available, hence a ban on their production, sale, distribution and use is necessary. Furthermore, the committee of experts formed by the government found these medicines unsuitable. The Drugs Technical Advisory Board also stated that there is no medical justification for combining these medicines after testing the combination medicine.
Why combination medicine is harmful
Combination medicine, which contains two or more active ingredients in a single dosage form, can be harmful in certain circumstances due to several factors:
Increased Risk of Side Effects: Since combination medicines contain multiple active ingredients, the risk of side effects or adverse reactions may increase. If a person is sensitive to one component, they may still experience unwanted effects even if the other component is necessary.
Difficulty in Adjusting Dosages: With combination medicines, it can be difficult to tailor the dosage of each active ingredient to meet individual patient needs. If a patient requires a higher or lower dose of one component, they may end up taking too much or too little of the other, leading to inefficacy or toxicity.
Drug Interactions: The combination of different drugs can lead to unintended interactions between the ingredients themselves or with other medications the patient is taking. Moreover, this can enhance toxicity, reduce efficacy, or cause unpredictable reactions.
Allergic Reactions: If a person is allergic to one of the components, they might still be exposed to it, even though they need the other component of the medication. This can lead to allergic reactions, which could be severe.
Masking of Symptoms: Combination drugs may mask certain symptoms, which could delay diagnosis or proper treatment. For example, a combination drug for pain and inflammation might reduce pain but also hide an underlying condition that needs medical attention.
Another reason for the ban
Overuse or Misuse: People might unintentionally overdose on one of the components of a combination drug if they are also taking another medication that contains the same ingredient. For example, taking a cold medicine and a painkiller that both contain acetaminophen could lead to an overdose of acetaminophen.
While combination medicines can be convenient and effective when prescribed properly, they do come with risks that need to be carefully considered by healthcare providers.
Pharmaceutical company’s reaction to the ban
Although pharmaceutical companies have already stopped producing some of the drugs included in the banned list. The pharmaceutical industry is currently analyzing what will be the economic impact of the ban. Moreover, companies like Cipla, Torrent, Sun Pharma, IPCA Lab and Lupine say this will affect their products.
The government had announced a ban on the manufacture, sale and distribution of 344 FDCs in 2016. As a result, the pharmaceutical companies in the court challenged this decision. However, 14 combination medicines were already banned in June 2023. Now the government has banned 153 medicines.
Combination medicine banned list
The drugs banned include the combination of the antibiotic azithromycin with adapalene, which is used to treat acne. At the same time, Aceclofenac 50mg Paracetamol 125 mg tablets have been banned. Above all, it is one of the popular combinations of pain relief medicines manufactured by top pharma companies. Furthermore, other drugs including combinations of paracetamol, tramadol, taurine and caffeine are banned. Here is the combination medicine banned list.
