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Pharma manufacturing tends to cause AMR in communities: Nick Voulvoulis

Changes are required both in manufacturing practices as well as in regulatory oversight, says Voulvoulis

Nick Voulvoulis
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Nick Voulvoulis, professor of environmental technology at the Centre for Environmental Policy, Imperial College, London

Sohini Das Mumbai

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Nick Voulvoulis is professor of environmental technology at the Centre for Environmental Policy, Imperial College, London. He has collaborated with Indian institutions for research that uncovered the link between antibiotic manufacturing in the country and the rise of antimicrobial resistance (AMR). Voulvoulis, in an email interview with Sohini Das, explained how low-cost antibiotics pressure manufacturers to spend on costly waste disposal. Edited excerpts:
 
Which AMR research projects are you working on?
 
I led a project called AMRWatch, which was one of five funded projects under the India-UK Tackling AMR in the Environment from Antimicrobial Manufacturing Waste programme funded by the UK’s Natural Environment Research Council and India’s Department of Biotechnology. The programme aimed to address the global challenge of AMR by investigating the role of antimicrobial manufacturing in the emergence of AMR in the environment.
 
Five collaborative projects were conducted across key manufacturing hubs in India; they assessed the impact of pharmaceutical waste on local communities and explored the role of manufacturing in AMR.
 
Can you provide examples of Indian manufacturing sites where the environment in local communities has been affected due to the pharma facility?
 
Across the programme, research focused on eight important manufacturing settings in India: Kangra, Baddi, Dera Bassi, Bhiwadi, Maharashtra, Hyderabad, Chennai and Pondicherry, with samples collected from water, sediment, soil and human and animal faeces from these areas. High concentrations of antimicrobials and resistance genes in water bodies near manufacturing sites were identified, highlighting the need to further investigate and address the environmental impact of antimicrobial manufacturing to combat the global AMR crisis.
 
For example, AMRWatch identified a high proportion of multidrug resistant isolates in the Chennai industrial site, where evidence of physicochemical contamination and an altered microbial ecosystem was found in proximity to the manufacturing site. 
 
What changes are needed in plant production and disposal of effluents to reduce such effluents?
 
Changes are required both in manufacturing practices as well as in regulatory oversight. These include cost-effective wastewater treatment technologies, such as photo catalysis, and the implementation of zero liquid discharge (ZLD) systems. Strengthening good manufacturing practices and enhancing regulatory frameworks are essential to ensure compliance and reduce environmental contamination.
 
One of the problems identified is the low cost of antibiotics, which, considering the high cost of waste treatment technologies, creates economic pressures for manufacturers. Competition and lack of transparency in the pharmaceutical supply chain further hinder efforts to adopt sustainable practices. Collaborative approaches, such as shared wastewater treatment facilities and horizontal industry collaboration, could potentially reduce costs and improve compliance. 
 
Have you shared the findings with the Indian government?
 
We had a major India Stakeholders Workshop (Indian Institute of Technology Bombay, December 4 & 5, 2023) and most of the findings have been shared with government departments through our partners in India.
 
What are key challenges in implementing better and greener manufacturing practices?
 
The Indian government expects manufacturing plants to use ZLD for effluents; a closed-loop system that involves primary, secondary, and tertiary treatment with a final evaporation step to minimize the final volume of effluent generated. Although ZLD has the potential to minimise antibiotic discharges to the environment, it has not been operationalized by most API (active pharmaceutical ingredient) plants, as it requires lots of energy and is expensive to implement. Moreover, there are no regulations to enforce or monitor compliance in place.
 
What kind of deaths and public health threats are anticipated due to AMR in India and globally in the next few decades?
 
An estimated 4.95 million global deaths were associated with AMR in 2019 and this number is only projected to increase. A landmark 2016 review by the UK government (the O’Neill Report) projected that 10 million deaths per year could occur globally by 2050 due to AMR if no action is taken, surpassing current annual deaths from cancer.
 
India already has a high burden of AMR, and by 2050 it is expected to be one of the worst-affected countries, with hundreds of thousands of AMR-related deaths annually, though exact projections vary.
 
Which are the main contributors for AMR?
 
There are many, including misuse and overuse of antibiotics in human health (inappropriate prescribing, over-the-counter sales, incomplete courses and self-medication); use of antibiotics in agriculture and animal husbandry(growth promotion, preventive use); environmental contamination (pharmaceutical manufacturing waste; hospital and agricultural runoff; improper sanitation and waste management); poor infection prevention and control; lack of access to quality health care and diagnostics; global travel and trade; slow pace of new antibiotic development; and weak surveillance and regulation. 
 
Which, according to you, are the most important initiatives by the government and private sector to prevent the rise of AMR in India?
 
India has taken several important steps, both at the government and private-sector levels, to combat AMR. The National Action Plan on AMR (NAP-AMR) – 2017–2021 is India’s central strategic framework aligned with the WHO Global Action Plan. It focuses on awareness, surveillance, infection prevention, antimicrobial stewardship, research, and international collaboration. It encouraged state-level AMR action plans (SAPs). As of 2024, over 10 states have developed or are developing SAPs. Key areas still needing strengthening include the need for enforcement of prescription-only sales, the regulation and monitoring of antibiotic use in informal healthcare settings and agriculture and better oversight of manufacturing sites.
 
Which Indian institutions are you working with?
 
For our project (AMRWatch), we collaborated with Pondicherry University as well as the Aarupadai Veedu Medical College & Hospital (AVMC), the Indian Institute of Technology (BHU) and the Indira Gandhi Medical College & Research Institute Varanasi (IGMCRI). Partners in the other projects included the Indian Institute of Technology Bombay, the Indian Institute of Technology Hyderabad, the Indian Institute of Technology Madras, the Indian Institute of Technology Gandhinagar, the Indian Institute of Technology Delhi, the Jamia Millia Islamia University and Panjab University amongst others.