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Manufacture Standards & Regulation, Small Molecules, Small Molecules

Testing the Water

Environmental campaigning organization, Changing Markets, recently published a report uncovering widespread antibiotic resistant bacteria in wastewater from pharmaceutical plants in India (1). Pollution from antibiotic manufacture is known to be a factor in the global spread of drug resistance, alongside excessive consumption of antibiotics in human medicine and their profligate use in livestock rearing. We spoke to the group about why – and how – the industry should address this important environmental issue.

Why focus on antibiotic pollution?

Pollution from the antibiotic manufacture is known to be a factor in the global spread of drug resistance, alongside excessive consumption of antibiotics in human medicine and their profligate use in livestock rearing.

This is still a relatively unexplored issue, despite a substantial and growing body of scientific evidence highlighting the negative environmental and human health impact of antibiotic residues. A series of studies (2)(3) over the past decade have revealed worryingly high concentrations of antibiotics in water near pharmaceutical manufacturing zones in India, associated with high rates of antibiotic resistance.

What did your investigation reveal?

Our report exposed the occurrence of resistant bacteria surrounding pharmaceutical manufacturing plants in India, which supply European and US markets. An on-the-ground investigation by the investigative agency, Ecostorm, and subsequent analysis of water samples under the supervision of Mark Holmes from the University of Cambridge found high levels of drug-resistant bacteria at sites in three Indian cities: Hyderabad, New Delhi and Chennai. Out of 34 sites tested, 16 were found to be harboring bacteria resistant to antibiotics.

How widespread is the problem?

This is just the tip of the iceberg. Our research is the equivalent of a “pilot study,” but of course more extensive research would be required to establish the full scale of the problem. Pharmaceutical pollution is an emerging issue and even developed regions, such as Europe, could make considerable improvements to their regulatory framework. For example, the European Commission’s Strategic Approach to pharmaceuticals in the environment is already more than a year late, which is concerning.

What can be done?

The Review on Antimicrobial Resistance characterize pharmaceutical manufacturing pollution as “a supply chain problem that pharmaceutical companies and their suppliers need to solve together,” (2). We couldn’t agree more. Pharmaceutical companies have a duty to stamp out pollution throughout the supply chain by implementing clean production and appropriate waste management at their own factories, as well as those of their suppliers. Companies need to integrate environmental criteria in all their contracts. Regulators must also act to include environmental criteria in the GMP framework and should be demanding more transparency in the pharmaceutical supply chain.

When it comes to addressing the global antimicrobial resistance challenge, tackling drug resistance due to irresponsible production and opaque supply chains is low-hanging fruit. This is an issue that must be addressed head-on across the board - failure to act will negatively impact the reputation of the industry as a whole.

Is the pharma industry taking appropriate action?

The pharma industry as a whole has been shockingly slow to take action on pharmaceutical pollution. More progressive companies are only now beginning to act on a decade’s worth of scientific evidence regarding the contribution of pharmaceutical pollution to the development of drug resistance. And at the other end of the spectrum, some players are clearly in denial. In India, civil society organizations have spent decades denouncing the pharmaceutical industry’s terrible environmental record but to no avail. Not all of these companies are household names in Europe and the US, but many of the firms they supply drugs to are. All players – whether they are simply purchasing APIs or other products from contract manufacturers, or manufacturing directly – have a duty to act on stamping out pollution in the drug supply chain. 

Companies sometimes blame lax regulation for environmental violations in the supply chain. While it is true that governments and regulators must clamp down bad practices, the bottom line is that this is a supply chain issue that companies themselves have a responsibility to address.

Is there anything that could be done by the regulators?

Regulators must act to include environmental criteria in the Good Manufacturing Practice (GMP) framework. A study by the Swedish Medical Products Agency back in 2011 concluded that this would be the most straightforward solution to the problem of manufacturing discharges as it would build on an existing system (5). GMP inspections should also be significantly strengthened, so that factories that fail to implement them lose their access to global markets.

In addition to this, regulators should demand more transparency in the pharmaceutical supply chain by asking companies to disclose the origin of their drugs right back to the factory that produced the raw materials. The textiles and electronics sectors again offer good examples of how this can be done.

The Strategic Approach to pharmaceuticals in the environment, which the European Commission is slated to publish by the end of this year, and which has already been delayed offers the first opportunity for Europe to act on these issues. In light of the threat that AMR represents, strong regulatory action should be a no-brainer. 

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  1. Changing Markets, “Superbugs in the supply chain”, (2016). Available at: Accessed Febuary 02, 2016.
  2. DGJ Larsson et al., “Effluent from drug manufactures contains extremely high levels of pharmaceuticals”, Op Cit, 148, 3, 751-755 (2007). PMID: 17706342.
  3. RH Lindberg et al., “Screening of human antibiotic substances and determination of weekly mass flows in five sewage treatment plants in Sweden”, Environ Sci Technol, 39, 10, 3421-3429 (2005). PMID: 15952345.
  4. J O’Neill, “Antimicrobials in agriculture and the environment: reducing unnecessary use and waste”, (2016). Available at: Accessed February 13, 2016.
  5. Swedish Medical Products Agency (Läkesmedelverket), “Platform to enable the initiation of a revision of EU legislation on Good Manufacturing Practice”, Available at: Accessed February 21, 2017.
About the Author
James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.


From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.

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