Europaudvalget 2020-21
EUU Alm.del Bilag 27
Offentligt
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Date:
Ref. nr.:
27 October 2020
20.39167
PHARMACEUTICAL POLLUTION IN INDIA AND EU’S ROLE
Introduction
India is among the countries worst affected by antimicrobial resistance (AMR),
with over 58,000 newborns estimated to die from drug-resistant infections
annually. One, often overlooked cause of AMR is
pollution from the
pharmaceutical industry.
Antibiotic residues from manufacturing plants enter
the environment in the form of wastewater and have been found in lakes,
streams and wells, leading to a high level of resistant bacteria. Few EU
pharmaceutical companies set discharge limits for external waste-treatment
sites, and none disclose active pharmaceutical ingredient (API) levels in
discharged wastewater. To this day, drug manufacturers continue pumping
huge quantities of inadequately treated pharmaceutical waste into the
environment (The Parliament Magazine, 2016). This excerpt will demonstrate
how a lack of transparency and regulation in the EU damages vulnerable
communities in India, for the sake of pharmaceutical industry profitability.
Impacts of pharmaceutical pollution on communities and environment in
India
As India is a low-cost manufacturing destination for multinational drug
companies, it acts as the major supplier to Europe and is home to many EU
pharmaceutical factories. The EU is completely dependent on third countries to
supply its own pharmaceutical market. In particular,
90 % of APIs
for generic
medicines are sourced from India (and China). (Parliament,
2020)
By
consequence, this dependence has accelerated pharmaceutical pollution in
many Indian cities and towns, damaging the land, water, food, and health.
Worse, pharmaceutical waste directly contributes to antibiotic contamination
further increasing AMR. (Nordea,
2016)
For instance, in the town of Bonthapalle, villagers avoid eating any food that
was grown in their own area. They are concerned for all the health problems at
play linked to such high pollution levels, notably miscarriages, cancers, and
deaths of livestock. Due to highly contaminated water, wells are dug far from
the town. Villagers who complain about the constant damage of pollution are
threatened by local police, who are complicit with the factory owners. (Nordea,
2016)
Another city, Hyderabad, is known as
the city drowning in
pharmaceutical pollution
. Villagers explain that if you drink the water, you
feel nauseas and have immediate diarrhoea. There used to be fish in the lakes;
however, wastewater from drug companies leaks into lakes and results in the
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death of hundreds of thousands of fish. Regarding agriculture, because the
groundwater is completely polluted, farmers are dependent on rainwater. If
there is no rain, then the harvest fails and the farmers suffer the consequences
(Canadian
Press, 2018).
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The Musi River is a major waterway that flows through Hyderabad, whose
smells are so bad that if you come close to it, your throat and eyes burn. A
study by the Indian Institute of Technology found that
antibiotic
concentrations were 1000 times higher in the Musi river than rivers found in
developed countries.
Villagers argue that the manufacturing industry damages
their land, water and food, but drug companies deny any involvement in
causing pollution to the environment, claiming there is no evidence (Canadian
Press, 2018).
Why is this occurring?
EU regulations in the shape of the Good Manufacturing Practice framework
(GMP) require that medicinal products are of consistent high quality, are
appropriate for their intended use, and meet the requirements of the market
authorization or clinical trial authorization (EMA). These requirements focus on
drug safety, but do not oblige companies to put in place environmental
safeguards when producing their drugs, despite the alarming and well-known
risks. The Commission has yet to respond to the calls from European NGOs and
the OECD recommendation for environmental criteria to be included in the
EU’s
GMPs. (Swedwatch,
2020)
As of today, there are currently no GMP
provisions regulating environmental emissions from the production of
medicinal products.
Another issue is how monitoring of manufacturing plants take place. Private
laboratories in India are paid by the pharmaceutical industry to carry out
Environmental Impact Assessments (EIA) of the pharmaceutical plants. These
assessments provide certificates saying that plants are well within the
standards despite potential issues. Because these labs are paid by the industry,
they have the incentive to give positive reports because else they will no longer
be hired. Cases from villagers against the pharmaceutical industry have been in
the courts since at least the 1980s. But, despite being paid by the
pharmaceutical industry, EIAs are considered expert testimony in court
whenever the waste management standards are called into question (Nordea,
2016).
EU Legislation on Pharmaceutical Pollution
Parliament’s call for action to tackle pharmaceutical pollution on
September 10,
2020
declared that the COM insufficiently acted and presented a serious delay
in developing concrete actionable plans and targets from the 2019
Communication.
The Co
issio ’s strategi approa h failed to de o strate
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the concrete steps it would take to improve pharmaceutical production.
(Swedwatch,
2020)
With a Motion for a Resolution, MEPs stressed for more
careful use of medicines, the development of greener manufacturing and
better waste management in the EU (Motion
for a Resolution, 2020).
MEPs
approved this resolution with 671 votes to 15 and 10 abstentions calling for
new measures to tackle pharmaceutical pollution, which causes long-term
damage to ecosystems, reduces drug efficiency and increases resistance to
antibiotics. Still, to this day, the Commission has yet to respond and no plan of
effective measures has taken place.
This has become a
Human Rights
issue:
According to The UN Guiding Principles (UNGP) on Business and Human Rights,
Business enterprises must respect human rights and have the responsibility to
prevent and mitigate the adverse human rights impacts associated with their
co pa y’s activities
. The UNGPs require companies to verify their
effectiveness in addressing the human rights issues associated with their
business activities. They are obligated to have consultation with affected
groups, and businesses must externally communicate how they address human
rights abuses.
A recent NGO investigation’s research and interviews in India revealed that
widespread environmental pollution from pharmaceutical manufacturers
violates lo al o
u ity e ers’ right
to a healthy environment, including
their access to clean water, air and soil. It further threatens their fundamental
right to life through long-term exposure to pharmaceutical residues and other
hazardous materials that are released into the environment . Furthermore, the
extreme concentrations of antibiotics and the presence of multi-resistant
bacteria found in rivers and lakes are further increasing the devastating impact
of AMR. (Swedwatch,
2020).
Conclusion
In addition to the 58,000 babies dying of AMR annually, India faces almost
57,000 deaths due to sepsis caused by drug-resistant bacteria.
While I dia’s
2017 national action plan on AMR includes intentions to monitor and regulate
industrial discharges of antibiotic residues, this may be hindered if the EU does
not increase transparency and accountability and reduces pharmaceutical
pollution. (The Parliament Magazine, 2018,
Swedwatch, 2020)
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20.39167
FC/27/10/20