Global procurement focus shifting to monitoring drug manufacturing practices
Antimicrobial Resistance (AMR) is a growing and significant health challenge worldwide. Though there is growing knowledge and efforts about the issue, it needs to be scaled up at factory, cluster and policy levels for manufacturing practices to meet global standards.
Without effective action on AMR, it is estimated that nearly 2 million deaths are projected to occur in India due to AMR by the year 2050, according to the Indian Journal of Community Medicine, 2019.
AMR refers to the ability of microorganisms such as bacteria, fungi, parasites and viruses to proliferate despite exposure to drugs designed to kill them or slow down their growth.
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India is a global drug manufacturing hub but also suffers from the highest levels of drug resistance globally. There are many causes of rising resistance today. The environmental contributions to AMR include the discharge of untreated antibiotic residues from factories and hospitals into local water bodies.
However, there is limited data that is scientifically verified and universally accepted to ascertain the cause-effect relationship specific to antibiotic manufacturing. Hence, the global focus has been on mitigating the human, agricultural and water, sanitation and hygiene contributions to AMR.
There is an urgent need to address the environmental contributions from antibiotic manufacturing to complete the missing part of the One Health approach to tackling AMR successfully.
India is the world’s largest producer of antibiotics, supplying over 40 per cent of the global market. The industry is diverse, with small, medium, and large companies engaged in active pharmaceutical ingredients and formulation manufacturing.
Over the last few years, there has been a growing concern due to the presence of high levels of antibiotic compounds in water resources near pharmaceutical manufacturing clusters due to the discharge of untreated effluents from the factories.
The emergence of cases across the country, from Baddi in Himachal Pradesh, Musi river in Telangana to Rangpo in Sikkim, is contributing to evidence of the growing concerns.
The National Green Tribunal has directed drug manufacturers in these states to reduce the discharge of untreated antibiotics into the environment and the central pollution control board to develop monitoring guidelines.
These practices are also leading to changes in global procurement practices of European governments, as shown by the Swedish National Agency for Public Procurement’s environmental criteria for procurement of medicinal products, including antibiotics.
The practices have also led to multinationals prioritising environmental goals in their procurement of antibiotics. Some Nordic countries have revised the selection criteria for the procurement of drugs based on the supplier’s environmental performance.
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In Norway, for example, “environmentally friendly production will be weighted by 30 per cent as allocation criteria” under the new system.
Global and multilateral financial institutions are also moving towards green financing as sustainability becomes a priority in environmental, social and corporate governance. The global shift towards green procurement could have adverse effects on the competitiveness of the Indian pharmaceutical industry.
Therefore, it is now critical to measure and monitor the impact of manufacturing antibiotics on the environment and human health. This must be validated based on scientific studies and water quality monitoring data.
Consumers, regulators, scientists, laboratories and the pharmaceutical industry are all struggling to determine the best approaches to address these challenges.
Since, at present, there is no universally accepted methodology for monitoring antibiotics, stakeholders need to collaborate to develop a common understanding and scientific basis for monitoring antibiotics in the environment.
The complexity of their manufacturing process in batches demands a more rigorous process of monitoring beyond the existing pollution control monitoring parameters.
The Union Ministry of Health and Family Welfare has spearheaded the efforts to develop a national action plan on AMR.
The Central Pollution Control Board (CPCB), under the Union Ministry of Environment, Forest and Climate Change, has spearheaded efforts to develop environmental standards and protocols for antibiotic monitoring in water bodies.
Draft antibiotic discharge and monitoring standards were proposed in 2020 and 2022. However, the guidelines still need to be formalised as many questions around monitoring and related processes still need to be answered.
Despite the recent efforts, there are gaps in establishing a common understanding of the presence of antibiotics in the environment and their impact on AMR.
In order to further our understanding of this relationship, it is important to enhance the monitoring framework by developing guidelines and policy recommendations for monitoring antibiotics in India.
We must also identify capacity-building, technology and infrastructure gaps, needs, and resources to implement the guidelines. These will require laboratory infrastructure investments, testing, monitoring capacity and training of industry and regulators.
Some companies have begun to monitor and adopt sustainable antibiotic manufacturing practices to meet global environmental standards. These efforts need to be scaled up at the factory, cluster and policy levels through incorporation into environmental components of national and state AMR action plans.
Siddhartha Prakash is the director for advisory firm Shawview Consulting
Views expressed are the authors’ own and don’t necessarily reflect those of Down To Earth
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