Can One State’s Bold Approach Lead in India’s Fight Against Superbugs?
By Arunima Rajan
In an exclusive interview with Healthcare Executive Magazine, Abdul Ghafur, Consultant in Infectious Diseases, Apollo Hospital, Chennai and Coordinator, Chennai Declaration on AMR shares his view on Kerala’s AMR Strategy.
What’s your take on Kerala’s AMR strategy?
Kerala's pioneering efforts in executing its comprehensive Antimicrobial Resistance (AMR) action plan serve as a model for the entire nation. A cornerstone of this initiative is the stringent implementation of the 2011 H1 rule introduced by the Indian Government, which prohibits the over-the-counter sale of antibiotics without a prescription. Kerala’s unwavering commitment to combating AMR is truly admirable. As a Keralite deeply engaged in AMR policy development at the national level, I take immense pride in the state's accomplishments. Nevertheless, I suggest that Kerala consider adopting the revised H1 rule of 2013. This modified regulation focuses on monitoring only second and third-line antibiotics while permitting the sale of first-line antibiotics without a prescription—offering a balanced approach to antibiotic stewardship, healthcare access, and economic considerations. Such a strategy would allow Kerala to provide a practical and replicable framework for other states across India.
What is the Indian government’s H1 regulation?
In 2011, the Indian government introduced the H1 rule to combat the escalating threat of antimicrobial resistance (AMR). This significant policy banned the over-the-counter sale of all antibiotics without a prescription. Nevertheless, until recently, Kerala was the only Indian state to implement this rule effectively. Kerala's strict enforcement led to notable reductions in antibiotic misuse. However, enforcing such an extensive ban on a national scale posed considerable challenges. In response, the Indian government revised the H1 rule in 2013, narrowing restrictions to 24 second and third-line antibiotics while allowing the sale of first-line antibiotics without requiring stringent monitoring. This revision offered a more adaptable and feasible solution, particularly for areas with limited access to healthcare professionals.
What are the key hurdles in enforcing a nation-wide ban?
While Kerala has successfully implemented the full ban under the 2011 H1 rule, the scenario looks quite different in many other Indian states. In rural regions and smaller towns, healthcare accessibility is limited, and imposing a complete ban on over-the-counter antibiotic sales could deprive individuals of essential treatment who find it challenging to consult a doctor. For instance, a woman residing in a remote village suffering from a urinary tract infection might struggle to leave her household duties for half a day to see a doctor. In such cases, she may rely on her local pharmacy for a first-line antibiotic like nitrofurantoin to alleviate her symptoms. Prohibiting access to these essential antibiotics without a prescription could result in untreated infections and severe health complications. No other Indian state besides Kerala has enacted any form of regulation on OTC antibiotic sales, and a nationwide ban, as mandated by the 2011 H1 rule, would be impractical for areas with such restricted access to healthcare professionals.
Besides healthcare challenges, a nationwide ban on OTC antibiotic sales would have major economic impacts. Kerala’s 2011 H1 rule enforcement cut antibiotic sales by ₹1,000 crore from ₹4,500 crore to ₹3,500 crore in a year, resulting in an overall drug sale drop by 8% to ₹15,000 crore. While this curbs antibiotic misuse, it raises economic concerns for small pharmaceutical producers, especially impacting the MSME sector which produces affordable medicines in India.
What are the economic consequences of nationwide ban
If this full ban on OTC antibiotic sales were to be implemented across the country, the economic impact could be even more severe. At the national level, annual losses could reach ₹10,000 crore, and with anti-infective sales valued at ₹30,000 crore annually, the consequences could be devastating for the MSME pharma sector. Many small pharmaceutical businesses might struggle to survive, ultimately leading to a monopolization of the market by large multinational corporations. This could severely restrict the availability of affordable medicines and widen the healthcare gap between different socioeconomic groups in India.
A more balanced and sustainable approach, such as the modified H1 rule of 2013, would allow essential first-line antibiotics to continue to be sold without strict monitoring of a prescription, while still addressing the misuse of more potent second and third-line antibiotics that contribute significantly to AMR. Once this approach is successfully implemented, we can gradually move toward a complete ban on OTC sales. This stepwise implementation would allow most states to adapt to the plan, and the MSME sector would have time to adjust to the new regulations without suffering severe financial losses.
Why do you believe the battle against AMR cannot be confined to a single state?
Although Kerala's proactive measures against AMR are commendable, addressing AMR requires a collective effort beyond just one state. AMR is not confined by borders, so Kerala's initiatives will have limited effectiveness unless neighboring states implement similar regulations. Presently, Kerala sources a substantial amount of its poultry and vegetables from adjacent states, many of which lack AMR controls for humans, animals, or agriculture. Research, including my own, indicates that these imported food items frequently contain antibiotic residues and drug-resistant bacteria, which can enter the human gut and share their resistance genes with other bacteria. This perpetuates a cycle of AMR spread, weakening Kerala's local efforts.
Kerala imports a significant portion of its agricultural products: 80% of its vegetables, 70% of its broiler poultry, and 55% of its eggs come from neighbouring states. These regions frequently lack regulation concerning antibiotic use in agriculture, contributing to the emergence and dissemination of antibiotic-resistant bacteria. To make Kerala’s antimicrobial resistance (AMR) initiatives sustainable, two strategies are available: Kerala could either halt the import of poultry and vegetables from other states, relying entirely on local production, or persuade neighbouring states to adopt rigorous AMR action plans. Yet, for neighbouring regions to embrace this, Kerala’s AMR practices must be scalable and practical for states with less advanced healthcare infrastructures. Should Kerala's methodology prove too stringent or impractical, other states might resist implementation, perpetuating the influx of antibiotic-contaminated products.
What adjustments should we make to the Kerala model?
For other states to adopt antimicrobial resistance (AMR) policies similar to Kerala’s, the Kerala model must be scalable and adaptable. This is where the modified H1 rule of 2013 presents a more practical solution. By concentrating on second- and third-line antibiotics while permitting less stringent monitoring for first-line antibiotic sales without prescription, this approach offers flexibility for states with differing levels of healthcare accessibility. Following the nationwide implementation of the modified H1 rule, Kerala and other states can gradually move towards a comprehensive ban on over-the-counter antibiotic sales.
By adopting a phased and flexible model, Kerala can ensure its initiatives to fight AMR are effective and set an example for other states to emulate. This strategy will foster a collective national effort against AMR, which is crucial for sustained success. Without collaboration from other states, Kerala's solitary actions will have minimal effect, and the persistent influx of drug-resistant bacteria from adjoining states will undermine its advancements.