India can lead the way in tackling antimicrobial resistance
With its scientific expertise, clinical resources and pharmaceutical sector track record, India may be the heart of the solution
by Manica Balasegaram · The HinduDrug-resistant infections may be a global killer, associated with nearly five million deaths a year, but a fifth of all these deaths occur in just one single country — India. Yet, despite this and being portrayed by the international community as the ground zero of the global antimicrobial resistance (AMR) crisis, India may be the heart of the solution. Because, given its scientific expertise, clinical resources and pharmaceutical sector, India has everything it needs to not only reverse the crisis within its own borders but also to lead the way in the global AMR response.
AMR is a growing threat
Such solutions are urgently needed because AMR has now reached an alarming tipping point. Having remained relatively flat for more than three decades, the global number of deaths associated with AMR is now expected to rise sharply. By the year 2050 it could increase by 70% and claim as many as 169 million lives. A key way to prevent this is by developing effective new treatments and ensuring that people get access to them. India is uniquely positioned to deliver on both of these, and, moreover, has a strong track record of doing so.
During the height of the HIV/AIDS epidemic, and then again, more recently, with the COVID-19 pandemic, India became one of the foremost producers and global suppliers of affordable medicines and vaccines. Similarly, in recent years India has also significantly increased access to childhood immunisation and, thanks to the largest and most ambitious national immunisation campaign pre-COVID-19, has for more than a decade been polio-free, a feat many experts thought not possible.
In theory, India can now have similar successes with AMR. Not just because it has the ability to develop much needed tools, such as new antibiotics, but also because it has all the key pieces in place required to develop the right antibiotics. This will be key as it will also help to address the chronic lack of access across the globe, which currently kills more people than drug-resistant infections.
Poor access is partly the result of fewer antibiotics being developed and manufactured. But even so, long before pharmaceutical companies started to withdraw from the market, millions of people, particularly those living in low- and middle-income countries (LMICs), were not getting the antibiotics they needed either because they were priced out of reach, not registered in their country or simply were not being developed in the first place. In addition, antibiotics were often not approved or formulated for those populations most at risk, such as children and infants.
Have dedicated R&D
If we are to change this, then a radically different approach is needed — one involving a research and development (R&D) ecosystem geared entirely towards affordable antibiotics targeting those multidrug-resistant infections that pose the greatest public health threat. And it is hard to imagine a country in a better position to achieve this than India.
First, there is India’s high burden of drug-resistant infections. The one advantage of this is that when trials or studies are carried out on larger and more relevant populations, the results tend to be a lot more robust. This is important not just in terms of ensuring that the right antibiotics are developed for the right kinds of drug-resistant infections, but also that they can be developed for groups which may be at high risk, but might otherwise be excluded from trials, such as newborns, women and people living with co-morbidities. Then there are India’s expert medical and scientific communities and its clinical trial networks. Under the auspices of the Indian Council of Medical Research (ICMR), these networks include research institutions and clinical research organisations which are helping to plug vital data gaps that are important for antibiotic development and introduction. Such trials can, for example, provide greater clarity on disease burden and antibiotic usage, and can help to identify solutions to important barriers to antibiotic access.
The third essential piece is India’s highly innovative biotech and pharmaceutical industry, which, in addition to innovative R&D, has a long history of commercial partnerships and technology transfers. Given that many biotech companies developing antibiotics are small and lack any kind of manufacturing capabilities of their own, such partnerships are essential to take a drug beyond the initial R&D. In addition, there are signs that Indian-based biotechs and innovator companies may be emerging that can help address AMR. And from an access perspective, establishing a pathway between innovation and manufacturing is also critical because it includes all the necessary activities to ensure that an antibiotic can be manufactured and commercialised at an affordable price and in sufficient supply.
In perspective
The final piece of the puzzle is India’s huge population, and the high antibiotic need that comes with it, both of which conspire to make a sustainable market for antibiotics possible. Because for antibiotics to be both affordable and financially viable, sufficient volumes are needed, which is precisely what India has. Given that the historic decline of antibiotic R&D is often blamed on market failures, the economies of scale of India suggest that some markets can in fact succeed.
The Global Antibiotic Research and Development Partnership (GARDP) is deeply involved with India, partnering with the ICMR as well as several pharmaceutical firms and manufacturers and carrying out studies within India. Because not only does India provide a way to tackle AMR differently but also because there is so much to gain from it.
If the Government of India were to further embrace this, such as through additional funding for clinical trials, capital expenditure grants for pharmaceutical companies, import waivers for key manufacturing equipment and by implementing pooled procurement models for antibiotics, this would not only bode well for India but also for the rest of the world. Partly because if India is able to tackle AMR domestically it will have a big impact on AMR globally. But also if India, once again, takes on the role of the global supplier and even innovator of affordable life-saving drugs, it will pave the way for other countries to tackle AMR too.
Dr. Manica Balasegaram is Executive Director, Global Antibiotic Research and Development Partnership (GARDP)
Published - November 24, 2024 04:30 am IST