As the world adjusts to the post-COVID-19 reality, it is time to reflect and reset. It cannot be ‘business as usual’ in the struggle to survive. The pandemic of COVID-19 has made everyone aware of the importance of masks and physical distancing. Yet the other silent ‘killer’ pandemic of antimicrobial resistance (AMR) that undermines health, including efforts to address COVID-19 is still unacknowledged.
AMR is the resistance of a microorganism (bacteria, parasites, viruses, or fungi) to an antimicrobial drug that was originally effective for the treatment of infections. When bacteria change in response to the use of antibiotics, they give rise to antibiotic resistance. AMR is one of the top ten global health threats which grows to undermine food security as well as sustainable development today. By 2050, it is projected to cause an estimated 10 million deaths per year and a loss of $100 trillion to the global economy.
Drivers of AMR include the irresponsible and indiscriminate use of antibiotics as ‘short cuts’ in human and veterinary sector in place of sustained improvements in infection prevention and control.
Unsurprisingly, in the interconnected ecosystem that we live in, AMR has other significant ways to spread. Effluents from animal farms, hospitals, homes and pharma plants are concentrates of antibiotics and resistant bacteria that contaminate the environment. A comprehensive ‘One Health’ approach that addresses these drivers in human, veterinary and especially the environment sector is needed to address AMR. The 2017 UN Environment Program Report categorically stated that the environment is the key to antibiotic resistance. Bacteria in soil, rivers and seawater can easily develop resistance by contact with resistance bacteria, antibiotics and disinfectants released by human activity.
India has one of the highest antibiotic resistance rates among bacteria that commonly cause infections in the community and healthcare facilities. In 2017, it announced the National Action Plan on AMR (NAP-AMR), based on the ‘One Health’ approach. It is historic as it declares the intention to ‘Strengthen India’s leadership on AMR’ as a key strategic objective besides ensuring surveillance of antimicrobial resistance – in human, animal and environment sectors (Strategic objective two).
As India rolls ahead with the much-needed ‘Atmanirbhar Bharat’ programme in pharma, it is the right time to lay the foundation for sustainable antibiotic production. The Indian pharma industry is the third-largest in the world by volume and 11th by value. With 3000 pharma companies and 10,500 pharma plants in the country, it produces 20 per cent of the world’s generic medicines and 60 per cent of the world’s vaccines. During the manufacturing process, there is a chance for residual material and active pharma ingredients to percolate into effluent water, which is then discharged into the surrounding environment. Scientific studies now delineate the important role of the environment, and more importantly, pharma effluents as an ecological driver in the emergence and spread of AMR. This can be easily addressed at the source.
The CDDEP report on Antimicrobial resistance in India (2017) listed 40 antibiotic API manufacturers and 250 antibiotic formulation companies manufacturing one or more antibiotics for human use. For AMR, the environmental contamination from the pharma plant effluents in these ‘hot-spots’ could be worrisome.
As part of the NAP-AMR implementation, India rolled ahead with the plan to develop standards for antibiotic residues in industrial effluents, particularly for those from pharma industries. It displayed its leadership in addressing AMR when in January 2020, the Ministry of Environment Forest and Climate Change (MoEFCC) released the draft standards for antibiotic residue in industrial effluent. The draft (Environment (Protection) Amendment Rules, 2019) provides stringent limits for 121 antibiotics and is also applicable to treated effluents from common effluent treatment plants (CETP) with membership of bulk drug and formulation units.
Since India (with China) manufactures almost 90 per cent of world’s active pharma ingredients (APIs) including antibiotics, the ‘Pharmacy of the World’ needs to address this issue for its own citizens. India’s leadership is being well acknowledged globally but these draft guidelines need to now be made mandatory. Additionally, the industry needs to put in place environment risk management (ERM) strategies in pharma plants. Efficient monitoring of these standards by regulators and adherence to the ERM strategies by the industry can be done meaningfully through public-private partnerships.
Interventions to address AMR from pharma effluents need leadership from both, the environment regulatory authorities and the pharma industry. The dynamic pharma industry and supportive regulatory system in India can establish key public-private partnerships that are needed to take concerted coordinated actions to tackle AMR in India. After all, we need to be united to save antibiotics!