By Valerio di Caprio
The pharmaceutical industry is the bedrock of modern medicine. Since discovering the earliest antimicrobials like Salvarsan, Prontosil, and penicillin, the industry has played a pivotal role in ushering in better health outcomes worldwide.
In particular, antibiotics are one of the most significant discoveries of medical science: the world’s first antibiotic – penicillin – was key to inducing a positive shift in mortality patterns from gastrointestinal and respiratory infections. Over the past 70 years, global life expectancy at birth has also increased due to the discovery of various classes of antibiotics. In the United States of America (USA) alone, antibiotics save over 200,000 lives annually.
While the discovery of antibiotics has been critical to human development, the increasing antimicrobial resistance (AMR) threatens the long-term efficacy of antimicrobial agents. Rising AMR has been touted as one of the top 10 threats to public health by the WHO. To make matters worse, the antibiotics currently under development are not sufficient to treat drug-resistant diseases. The rampant overuse and misuse of antimicrobials like antibiotics in human and veterinary medicine, along with the improper discharge of pharmaceutically-active effluents into the environment, accelerate the build-up of AMR in pathogens. The diminished effectiveness of antibiotics causes infections longer to heal and, in some cases, not heal at all, hence leading to mortalities. This is no longer a theoretical proposition: AMR has complicated the treatment of diseases like tuberculosis (TB), and the World Health Organization (WHO) estimates that a significant portion of the global detections of TB in 2018 was resistant to the two most potent anti-TB drugs.
The ramifications of increased AMR are not just an issue between governments: its mitigation is a collective responsibility of the various stakeholders involved – government, industry, academia, scientific and medical experts, and of course, the public. The global and national plans that have been drawn out for AMR mitigation encourage collaboration between all stakeholders. Situated in the One-Health Approach, these action plans encourage de-siloed measures across the interconnected animal, environment, and human ecosystems.
While the pharmaceutical industry has enabled better health outcomes, it can unknowingly undo the progress due to the improper discharge of pharmaceutically active effluents into the environment. In addition to degrading the environment, this also gravely contributes to an uptick in environmental AMR. The emphasis on clean procurement of raw materials for antibiotic production is an important aspect the industry must address: when raw materials are procured within environmentally responsible frameworks, it facilitates sustainable production.
Enforcing strict protocols to produce antibiotics Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDF) is an important pillar of AMR mitigation. The industry can complement the ongoing global and national measures. In the absence of effective effluent treatment facilities and lack of enforceable standards, potent pharmaceutical compounds escape into the water bodies, potentially leading to an uptick in environmental AMR. Of late, there has been a spurt in cases of antibiotic pollution, with the more recent one from the pharmaceutical hub of Baddi, located in the Indian state of Himachal Pradesh.
There is a dire need for global standards backed by a sound regulatory framework to govern the discharge of antibiotic concentrations in wastewater. Additionally, the pharmaceutical companies can also self-regulate by adhering to AMR Alliance’s antibiotic discharge targets, improving the efficacy of their wastewater treatment plants, and undertaking a regular life-cycle assessment of their manufacturing plants.
Apart from emphasizing sustainable production, Industry leaders’ emphasis on sustainable procurement can nudge the suppliers to weave environmentally responsible practices into their production. Further, supply chain transparency should be encouraged by aligning the suppliers to business risks of increased AMR. Countries like Norway and Sweden have already tinkered with market incentives to promote sustainable antibiotic manufacturing. While the Swedish County Councils use environmental criteria in pharmaceutical procurement, suppliers’ sustainability profile in Norway accounts for 30 % of the procurement score criteria.
Additionally, the United Nations launched its Sustainable Procurement in the Health Sector Initiative (SPHS) with a purchasing power of USD 5 billion to drive sustainable procurement. Importantly, China and India are key players in the global supply chain of pharmaceuticals. While India is the largest producer of generic medicines globally, various countries depend on China for APIs. Therefore, a transition to sustainable procurement and production in these countries would protect the global interests of the industry and contribute to mitigating AMR growth.
Without urgent course corrections, we are staring at 10 million mortalities every year by 2050, coupled with substantial dents to the global economic paradigm. Moreover, when manufactured drugs fail to cure infections, the pharmaceutical industry would be adversely impacted. The industry must prioritize long-term sustainability over short-term profits by transitioning to sustainable procurement and production pathways. Globally, we see increased commitment from the industry to reduce AMR risks through good manufacturing processes. Being a global leader in this sector, India needs to emulate such best practices of sustainable production, well supported by the governments, policy makers, investors, and purchasers resulting in sustainably produced antibiotics and reduced perils of AMR on the economy and society.
The columnist is Global Franchise Director – SSP and PEN, Centrient Pharmaceuticals. Views expressed are the author’s own.