The launch of Nafithromycin and other new drugs developed by India in response to antimicrobial resistance (AMR) is part of a larger national effort that highlights the country's leading position in healthcare on a global scale.

Due to its long history of providing affordable generic pharmaceuticals and vaccinations, India has earned the nickname "pharmacy of the world" among people worldwide. Nevertheless, the country's potential for developing innovative drugs has been underutilised.

Pharmaceutical companies around the world are working tirelessly to find new ways to fight the rising tide of antimicrobial resistance. A breakthrough has finally surfaced after years of difficulty and unrelenting labour. The development of Nafithromycin, the first indigenous Macrolide antibiotic in India, is the result of thirty years of dedicated research and development. The fight against antimicrobial resistance has reached a turning point, and this significant achievement highlights India's growing strengths in pharmaceutical innovation.

The Battle Against Antimicrobial Resistance in India

The "silent pandemic" that might undo decades of medical advancement is antimicrobial resistance (AMR). By 2050, the annual death toll from AMR might reach 10 million. One of the leading causes is pneumonia, which strikes low- and middle-income nations more severely than others. Among the world's pneumonia fatalities, 23% occur in India, where 4 million Community-Acquired Bacterial Pneumonia (CABP) cases are reported annually.

The eradication of antibiotic effectiveness by some microorganisms is known as antimicrobial resistance (AMR). The ineffectiveness of antibiotics and other antimicrobial treatments makes infections harder or impossible to cure; this, in turn, increases the risk of disease spread, serious illness, disability, and death. Although AMR is caused by genetic changes in microbes over time, human activities, especially the abuse and misuse of antimicrobial medications in plants, animals, and people, greatly speed up its spread. Around 6 lakh lives are lost in India every year owing to illnesses that are resistant to antimicrobials, making antimicrobial resistance (AMR) a serious worldwide health concern. Nonetheless, India is tackling AMR head-on, especially in the pharmaceutical industry.

An important step in this endeavour is the development of Nafithromycin, which received ₹8 crore in financing from the Biotech Industry Program of the Biotechnology Research Assistance Council (BIRAC) for Phase 3 clinical studies. With no new antibiotics on the market for some time, the introduction of Nafithromycin is particularly crucial given that India is responsible for a disproportionately high number of cases of pneumonia worldwide. To treat antimicrobial resistance (AMR), Nafithromycin is an essential step that improves patient compliance.

The Public Health Milestone: Nafithromycin

On November 20, 2024, Nafithromycin was formally introduced. Community-Acquired Bacterial Pneumonia (CABP) is caused by drug-resistant bacteria and disproportionately affects vulnerable populations like children, the elderly, and those with compromised immune systems. Wockhardt developed Nafithromycin, marketed as "Miqnaf," with support from the Biotechnology Industry Research Assistance Council (BIRAC).

With a three-day treatment schedule and 10 times the efficacy of existing medicines like azithromycin, this revolutionary antibiotic drastically reduces recovery time and improves patient outcomes. Nafithromycin is an important tool in combating the worldwide problem of antimicrobial resistance (AMR) since it can cure both common and uncommon types of bacteria that are resistant to drugs. It has no major medication interactions, is quite safe, and has few adverse effects.

As the first novel antibiotic of its kind to be launched worldwide in more than 30 years, the creation of nafithromycin is a watershed moment in medical history. The medicine is currently seeking final approval from the Central Drugs Standard Control Organisation (CDSCO) after undergoing thorough clinical studies in the US, Europe, and India, and with an investment of ₹500 crores.

Measures Taken by the Government to Combat Antimicrobial Resistance

In addition to creating Nafithromycin, the Indian government has launched a number of important programs to raise awareness about the problem of antimicrobial resistance (AMR) and encourage people to work together to find solutions. Improvements in infection control, strengthening of national and international relationships, and containment of antimicrobial resistance are the primary goals of these initiatives.

1. Monitoring and Reporting: Laboratories throughout the nation are part of national surveillance networks that compile yearly reports on antimicrobial resistance (AMR) and transmit the data to the Global AMR Surveillance System (GLASS).
2. Education and Training: Stakeholders have been provided with awareness materials that emphasise the need to practice good hand hygiene, avoiding the spread of infections, and the prudent use of antimicrobials. Infection prevention guidelines at the national level have been released, and all 50 states and the District of Columbia have participated in a "train-the-trainer" program, with further training cascading down from the states.
3. Use of Antimicrobials Decently: Tertiary care hospitals have begun monitoring antibiotic use to encourage responsible usage. NAP-AMR, or the National Action Plan on Antimicrobial Resistance, is in line with the GAP-AMR and was launched in 2017. The original duration of the plan was five years, and it has now been extended to encompass more than one ministry.
4. Development of NAP-AMR 2.0: The development of NAP-AMR 2.0, which includes a SWOT analysis and suggestions for AMR research policies, was the result of national discussions that took place in 2022 and involved sectors such as human health, research, the environment, and animal husbandry.
5. The Red Line Campaign: This initiative was started by the Ministry of Health and Family Welfare (MoHFW) to bring attention to the risks of taking antibiotics without a prescription. People should only take antibiotics that have a red vertical line on them if their doctor has specifically prescribed them, according to the advertising.
6. ICMR recommendations: Prevention and treatment recommendations for viral bronchitis and low-grade fever have been released by the Indian Council of Medical Research (ICMR) to control antibiotic overuse. Avoiding the overuse of antibiotics is the primary goal of these recommendations.
7. Antibiotics Under Schedules H and H1 of the Drugs Rules, 1945: Medications containing antibiotics are restricted to sale by certified medical practitioners only and are classified under Schedules H and H1 of the Drugs Rules, 1945. Medical records for drugs included in Schedule H1 must also be meticulously preserved for three years.
8. Notification from CDSCO Regarding High-End Antibiotics: Two-hundred-four antimicrobials have been placed on Schedule H1 by the Central Drugs Standard Control Organisation (CDSCO), requiring stringent control and supervision to avoid abuse.

Through cross-sectoral collaboration, these programs seek to combat the growing danger of antimicrobial resistance. The pharmaceutical business in India also plays an important role in improving the country's healthcare system, which helps these antimicrobial resistance containment initiatives.

Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.