By: Amanjeet Singh and Samriddhi Gupte
When India announced its first home-grown antibiotic Nafithromycin last November, it was touted as a breakthrough in the country’s fight against deadly superbugs. However, medical experts warn that creating new drugs is not enough – we need smarter ways to introduce them into healthcare systems to prevent antibiotics from becoming resistant too quickly.
This call for systematic drug introduction gains new urgency with the Central Drugs Standard Control Organization’s (CDSCO) releasing diagnostic validation guidelines, highlighting the need for comprehensive approaches deal with silent pandemic of antimicrobial resistance.
To safeguard modern medicine and prevent deaths, India must protect both existing and new antibiotic molecules by prolonging their life cycle through sustainable entry strategies,” says Dr Ranga Reddy Burri, Honorary Professor at the University of Hyderabad and President of the Infection Control Academy of India.
The challenge is stark: India lost 300,000 people to antimicrobial resistance (AMR) in 2019 alone. While the country’s robust pharmaceutical industry makes antibiotics affordable and accessible, this blessing often becomes a curse. A 2014 Mumbai survey found that less than half of people consult a doctor before taking antibiotics, risking dangerous drug interactions. Globally, AMR now kills more people annually than HIV/AIDS, malaria or COVID-19, with 1.27 million deaths reported in 2022.
“Currently, antibiotics are not just prescribed by trained doctors – they are sometimes prescribed based on assumptions and are often freely available in pharmacies,” explains Dr Subbalaxmi Malladi, Professor of Internal Medicine at NIMS Hyderabad. “We urgently need a systematic approach to help healthcare professionals follow evidence-based guidelines.”
This widespread misuse makes pharmaceutical companies hesitant to bring new antibiotics to countries like India. Between 1999 and 2014, only 12 out of 25 new antibiotics reached more than ten low- and middle-income countries.
Learning from Past Experiences
India’s contrasting experiences with two important antibiotics show why careful planning matters. Take Bedaquiline, a tuberculosis drug: Its introduction followed a careful, phased approach starting with controlled trials. Access expanded gradually as healthcare systems proved they could manage it properly.
Compare this with Ceftazidime-Avibactam, introduced in 2018. Though initially restricted to major hospitals, it became generic in 2023 and is now widely available in pharmacies. The introduction patterns are also linked to the development of resistance.
Thus, there is a need to develop an alternative drug introduction pathway that ties stewardship to procurement and access, ensuring the responsible launch of the new antibiotic.
“Any new drug should be used judiciously and rationally,” emphasises Dr PVM Lakshmi, Professor at PGIMER Chandigarh. “India should prepare ahead of the introduction of new drugs in the market so that proper use can be promoted.”
A New Path Forward
Recent field work in Punjab, Telangana, and Kerala by the Max Institute of Healthcare Management at Indian School of Business points to a solution: need for sustainable use pathway. The key lies in strengthening antibiotic monitoring at all healthcare facilities – from local clinics to major hospitals. By tracking how these drugs are used and ensuring they are prescribed only when necessary, India can preserve these life-saving medicines for future generations while ensuring they reach those who truly need them today.
Evidence shows that pharmaceutical companies are concerned in bringing new antibiotics to LMICs like India as without appropriate use it could lead to rapid development of resistance and loss of effectiveness in global markets.
Careful use of antibiotics or stewardship is a central ask for informing innovative sustainable use pathways for antibiotics. Innovative action is needed to gear health systems exploring an alternative pathway – a sustainable use framework that seamlessly links access to stewardship and is integrated into country health systems and priorities for timely monitoring and evaluation.
This includes establishing and strengthening stewardship practices at facility level, (public, private or NGO type), and analyzing data across these healthcare facilities in a systematic manner to ensure that new drugs are used responsibly.
