Executive summary

This report explores the impacts of pollution from pharmaceutical production sites in the Indian city of Hyderabad, one of the world’s largest “bulk drug” manufacturing hubs, which supplies tonnes of medicines to markets across the European Union and United States every year.

As part of its ongoing engagement with drug companies and their suppliers regarding pollution in the pharmaceutical supply chain, and following the publication of “Impacts of Pharmaceutical Pollution on Communities and Environment in India” in March 2016, Nordea commissioned the Changing Markets Foundation to conduct a follow-up investigation in India, the results of which are presented here.

Based on findings from two field trips (one in April 2017, during the dry season, and one in September 2017, during the rainy season), interviews with NGO experts and people living or working in the affected areas as well as in-depth analysis of media coverage and academic studies, this report confirms the findings of the 2016 study by showing that pharmaceutical companies in Hyderabad are continuing to discharge untreated or inappropriately treated wastewater into the environment and that local and national authorities are failing to get the situation under control. It concludes that the situation in Hyderabad has not improved in the past two years – if anything, it has deteriorated. Furthermore, with plans afoot to expand the city’s pharmaceutical production capacity over the coming years and the lack of credible regulation and measures to control manufacturing emissions, the future looks grim for the area’s inhabitants.

The centrepiece of the report are results from the testing of water samples collected adjacent to pharma factories and some of the city’s waterbodies in September 2017 which highlight the occurrence of a range of heavy metals and industrial solvents commonly used in pharmaceutical manufacturing. In some cases, these were found to be present at extremely high concentrations, orders of magnitude higher than maximum regulatory limits or safe exposure levels, which points to substantial human and ecological risk potential.

The mere presence of some of these substances is cause for alarm given their extreme toxicity. In addition, the occurrence of mixtures of chemicals shows a lack of adequate water treatment prior to discharge (or potentially no treatment whatsoever). Depending on the water flow in receiving water bodies, and the distance from the effluent source, the actual concentrations of these chemicals from the discharge source could be many magnitudes greater that the concentrations detected in samples.

These findings come amidst repeated warnings from the scientific community about the dire state of India’s water resources. Numerous factors, including climate change, industrial activity and a growing population are placing unbearable pressure on the country’s water, drying up rivers and lakes and precipitating a dramatic decrease in groundwater. This is already causing acute social and economic distress which is only predicted to worsen over the coming years. Beyond the evident human health impacts, the corporate sector, including the pharmaceutical industry itself, also depends on a reliable supply of clean water. The effects of water stress and pollution therefore present a substantial material risk for businesses operating or using suppliers in India.

India’s Environment Ministry classifies pharmaceutical manufacturing as a “red category” activity owing to the hazardous waste it produces. Successive studies have shown that air, water and soil in Telangana state (of which Hyderabad is the capital) are significantly contaminated by toxic chemicals and heavy metals such as copper, lead, mercury and arsenic. One 2001 article recommended that “Most of the soils should be removed from agricultural production” in Patancheru, the industrial area on the outskirts of Hyderabad where many of the city’s pharmaceutical factories are situated. A report published in the Journal of the Geological Society of India in October 2017 showed that groundwater in the Nalgonda district to the east of Hyderabad contains toxics including lead, cadmium, vanadium and arsenic “in concentrations that are thousands of times higher than the maximum levels prescribed for drinking water quality by the World Health Organisation (WHO) and Bureau of Indian Standards (BIS).” The paper reported that one likely origin of the pollution is “the release of reactive pollutants into the atmosphere by industries”, listing the pharmaceutical industry as one of the area’s key ‘anthropogenic’ activities.

Pharmaceutical pollution, whether from the excretion of drugs or industrial activity, carries specific dangers for human health and ecosystems ranging from the near elimination of entire species9 to the feminisation of fish and the spread of antimicrobial resistance (AMR). Furthermore, pharmaceutical manufacturing also uses large quantities of solvents – which are often highly toxic chemicals – and heavy metals, whose long-lasting impacts on human health have been proven and whose use is therefore regulated in many countries.

Of particular relevance here, a series of studies over the past decade have linked uncontrolled manufacturing discharges from antibiotics factories in Hyderabad with the spread of AMR, a global health threat which could kill more people than cancer by 2050. In its Frontiers 2017. Emerging Issues of Environmental Concern report, UN Environment identifies growing AMR linked to the discharge of drugs and particular chemicals into the environment as one of the most worrying health threats today, noting the role that heavy metals can play in “co-selecting” for drug-resistant bacteria alongside high concentrations of Active Pharmaceutical Ingredients (APIs). At the report’s launch, UN Environment Executive Director Erik Solheim drew particular attention to a pharmaceutical facility in Hyderabad, where testing of discharged water revealed that the concentration in the treated wastewater of ciprofloxacin, a vital broad-spectrum antibiotic, was strong enough to treat 44,000 people.

Because of the globalised nature of today’s pharmaceutical industry and inter-connected world where disease and drug resistance can spread rapidly, what happens in India concerns us all.