Keywords Sustainability - Regulation - Pharmaceuticals in the environment - Pharmaceutical
industry - Environmental classification - Green chemistry
Highlights the critical need for sustainable materials in pharmaceutical production.
Addresses environmental concerns, promoting eco-friendly practices.
Explores innovations that reduce resource consumption and waste.
Supports regulatory compliance and corporate responsibility.
Encourages adoption of green chemistry principles.
Aims to improve long-term industry sustainability and cost efficiency.
Provides strategies for overcoming material supply challenges.
Introduction
Indeed, the sustainable development goals (SDGs) provide an all-encompassing framework
intended to tackle a broad spectrum of worldwide issues. The 17 goals ratified by
all UN member states in 2015 seek to eradicate poverty, safeguard the environment,
and guarantee prosperity for all people by 2030. Here is a brief description of each
objective:
No Poverty: Eradicate poverty in all its forms everywhere.
Zero Hunger: This aims to eradicate hunger, increase nutrition and food security, and advance
sustainable agriculture.
Good Health and Well-being: Make sure everyone, regardless of age, has a healthy life and is encouraged to be
well.
Quality Education: Make sure that everyone has access to inclusive, equitable quality education, and
encourage lifetime learning opportunities.
Gender Equality: Make gender equality a reality and give all women and girls more authority.
Clean Water and Sanitation: Guarantee that everyone has access to clean water and sustainable sanitation management.
Affordable and Clean Energy: Make sure that everyone has access to modern, cheap, trustworthy, and sustainable
energy.
Decent Work and Economic Growth: Encourage full and productive employment, consistent, inclusive, and sustainable
economic growth, and decent work for all.
Industry, Innovation, and Infrastructure: Encourage inclusive and sustainable industrialization, develop innovative ideas,
and construct robust infrastructure.
Reduced Inequality: Lessen inequality both within and across nations.
Sustainable Cities and Communities: Make human settlements and cities robust, safe, inclusive, and sustainable
Responsible Consumption and Production: Make sure that patterns of consumption and production are sustainable.
Climate Action: Act quickly to mitigate the effects of climate change.
Life below Water: Conserve and sustainably use the oceans, seas, and marine resources for sustainable
development.
Life on Land: Protect, restore, and promote sustainable use of terrestrial ecosystems, manage forests
sustainably, combat desertification, halt and reverse land degradation, and halt biodiversity
loss.
Peace, Justice, and Strong Institutions: Encourage inclusive and peaceful societies for long-term growth; guarantee everyone's
access to justice; and create inclusive, accountable, and strong institutions at all
levels.
Partnerships for the Goals: Reinvigorate the worldwide partnership for sustainable development and strengthen
the means of implementation.
Global cooperation from governments, businesses, civil society organizations, and
individuals is needed to accomplish these aims. Since these objectives are interrelated,
advancement in one area can bolster advancement in other areas, which is why integrated
techniques are crucial.
Materials sustainability in the pharmaceutical industry involves managing materials
and resources in a way that minimizes environmental impact, ensures long-term availability
of resources, and promotes ethical practices throughout the supply chain as shown
in [Fig. 1 ]. This involves utilizing renewable feedstock, designing safer chemicals, and optimizing
synthetic routes to enhance efficiency while minimizing environmental footprint. The
environmental effects of medications emerge across their entire life cycle. While
the pharmaceutical industry plays a crucial role in minimizing these effects during
early production stages, opportunities to reduce environmental impacts stemming from
drug consumption and disposal are currently limited.
Figure 1 An overview of cradle-to-gate and cradle-to-grave life cycle assessments in the pharmaceutical
industry, along with key actions and strategies to minimize environmental impacts.
The pharmaceutical industry faces growing pressure to integrate sustainable practices
into its operations due to environmental concerns and regulatory requirements. Material
sustainability, focusing on the responsible use of resources and minimizing environmental
impact, has emerged as a crucial aspect of this transformation. Key strategies include
the adoption of green chemistry principles to reduce hazardous substances and waste
generation during drug development and manufacturing processes. Biodegradable materials
and eco-friendly packaging designs are increasingly favored to mitigate the industry's
impact on landfills and ecosystems [1 ], [2 ].
Furthermore, the implementation of sustainable packaging solutions aims to reduce
carbon emissions and enhance recyclability. Moreover, initiatives promoting the circular
economy model are gaining traction, encouraging the reuse, recycling, and repurposing
of pharmaceutical materials and byproducts. This shift toward a closed-loop system
not only conserves resources but also reduces overall waste and enhances resource
efficiency.
Challenges remain, including the complexity of regulatory frameworks and the need
for collaborative efforts across stakeholders to achieve meaningful progress in material
sustainability. However, ongoing research and innovation continue to drive advancements
in sustainable practices within the pharmaceutical sector [3 ], [4 ].
Importance of Material Sustainability in the Pharmaceutical Industry
Importance of Material Sustainability in the Pharmaceutical Industry
Materials sustainability in the pharmaceutical industry represents a pivotal shift
toward environmentally responsible practices, driven by innovation, regulation, and
a collective commitment to safeguarding our planet's resources for future generations.
The importance of materials sustainability in the pharmaceutical industry lies in
its ability to minimize environmental impact, ensure resource efficiency, and promote
ethical practices throughout the supply chain. This approach supports the long-term
availability of resources, reduces waste generation, and enhances the overall sustainability
credentials of pharmaceutical products and processes. By focusing on sustainable materials,
the industry can mitigate ecological footprints and contribute positively to global
environmental goals while maintaining high standards of product efficacy and safety.
It is crucial in the pharmaceutical industry due to its role in reducing environmental
impact, optimizing resource use, and fostering ethical practices across the supply
chain. This approach ensures the long-term availability of resources, minimizes waste
generation and enhances the overall sustainability of pharmaceutical products and
processes. Material sustainability in the pharmaceutical industry is not only about
environmental stewardship but also about ensuring ethical operations, regulatory compliance,
cost efficiency, and long-term business resilience. It is a crucial aspect of corporate
strategy that aligns environmental goals with business objectives, benefiting both
the industry and society at large [5 ], [6 ].
Materials sustainability in the pharmaceutical industry is of significant importance
due to several key reasons as shown in [Fig. 2 ].
Figure 2 Importance of sustainability in pharmaceutical industry.
1.
Environmental Impact
Pharmaceutical manufacturing processes can have substantial environmental impacts,
including energy consumption, water usage, and emissions of greenhouse gases and other
pollutants. Material sustainability focuses on reducing these impacts through efficient
use of resources, waste reduction, and adoption of cleaner technologies.
Example: Energy Consumption Reduction:
Implementation of Energy-Efficient Technologies: Utilizing energy-efficient equipment and processes, such as advanced reactors, energy
recovery systems, and high-efficiency HVAC systems, can significantly reduce energy
consumption.
Renewable Energy Sources: Transitioning to renewable energy sources, such as solar, wind, or biomass, for powering
manufacturing facilities can reduce greenhouse gas emissions.
2.
Resource Conservation
Many pharmaceutical products rely on natural resources such as plant extracts or minerals.
Ensuring the sustainability of these resources is crucial to avoid depletion and to
maintain biodiversity. Sustainable sourcing practices can help mitigate these risks.
Example: Water Usage Optimization:
Water Recycling and Reuse: Implementing water recycling systems to reuse water in nonpotable processes, such
as cooling towers and irrigation, can reduce overall water consumption.
Efficient Water Management Practices: Using advanced water management techniques, such as closed-loop systems, can minimize
water waste and improve water use efficiency.
3.
Regulatory Compliance
Governments and international bodies are increasingly imposing regulations and standards
related to environmental sustainability. Adhering to these regulations not only avoids
legal penalties but also enhances the industry's reputation and reduces operational
risks. Potential regulations such as a carbon tax can play a significant role in driving
the pharmaceutical industry toward more sustainable practices. Here are some ways
in which these regulations can impact the industry and examples of how they might
be implemented:
Carbon Tax
A cost based on the amount of carbon in fuels is called a carbon tax. Its purpose
is to increase the cost of emitting carbon dioxide in order to promote the decrease
of greenhouse gas emissions.
Need for Carbon Tax
Imposing taxes on sources of environmental pollution and greenhouse gas emissions
is a highly efficient and effective method to address climate change, biodiversity
loss, and pollution. Additionally, environmental taxes can aid in generating revenue
and promoting equitable redistribution. The Organisation for Economic Co-operation
and Development’s (OECD) research and data play a key role in ensuring that green
taxes incentivize eco-friendly behaviors while aligning with broader tax policies
aimed at fostering fair and sustainable economic growth.
Carbon pricing is an efficient method for lowering emissions, offering households
and businesses incentives to reduce their reliance on carbon-heavy energy and transition
to cleaner alternatives, while also generating government revenue. However, according
to the OECD’s latest Effective Carbon Rates report, 58% of greenhouse gas emissions in 72 surveyed countries remain unpriced,
and only 7% face a carbon price aligned with the societal cost of CO₂ emissions (EUR
60 per tonne). Despite this, the momentum behind carbon pricing is evident, with the
share of emissions covered by Emissions Trading Systems (ETSs) doubling from 13 to
27% in recent years.
Impact on the Pharmaceutical Industry:
Increased Costs for High Emissions: Businesses with large emissions of greenhouse gases would have to pay more for operations,
which would encourage them to cut back on their carbon footprint.
Investment in Clean Technologies: To avoid the tax, companies might invest in cleaner technologies and more energy-efficient
processes.
Shift to Renewable Energy: Pharmaceutical businesses might switch to alternative energy sources in order to
lessen the tax's financial impact.
Examples of Implementation:
European Union: The Emissions Trading System (ETS), which was put into place by the European Union
(EU), essentially charges high-emission businesses for their carbon emissions. It
accomplishes a similar goal to a direct carbon price by limiting overall emissions
and permitting the market of emission permits.
Canada: Fuels like gasoline, diesel, and natural gas are subject to a carbon tax under the
country's recently implemented federal carbon pricing scheme.
4.
Supply Chain Resilience
By ensuring sustainability throughout the supply chain, risks related to resource
scarcity, regulatory modifications, disruptions brought on by climate change, or geopolitical
reasons are reduced. This toughness is essential to preserving a steady flow of medications.
Example: Although the pharmaceutical business and its worldwide supply chain are vital to
the healthcare system, they also have a big effect on the environment. The chain of
operations in this industry has a significant carbon footprint, ranging from the extraction
of raw materials to the disposal of medications.
The Greenhouse Gas Protocol created a framework for classifying greenhouse gas (GHG)
emissions into Scopes 1, 2, and 3 to assist enterprises in fully comprehending and
managing their emissions. Below is a summary of every scope:
Scope 1: Direct Emissions
Definition: Direct greenhouse gas emissions from sources under the company's ownership or control
are referred to as Scope 1 emissions.
Examples:
On-site Combustion: Emissions from burning fossil fuels in company-owned or controlled vehicles, boilers,
and furnaces.
Process Emissions: These are emissions emitted during industrial operations, like chemical reactions
in the production of pharmaceuticals.
Fugitive Emissions: Inadvertent discharges of greenhouse gases, such as gas pipeline or refrigeration
equipment leaks.
Impact on the Pharmaceutical Industry:
Pharmaceutical businesses usually have high Scope 1 emissions due to their large manufacturing
facilities and substantial logistics operations.
Reducing Scope 1 emissions can be achieved by introducing energy-saving techniques,
moving to cleaner fuels, and enhancing maintenance procedures.
Scope 2: Indirect Emissions from Energy
Definition: Indirect greenhouse gas emissions from the production of bought or acquired power,
steam, heating, and cooling that the business uses are referred to as Scope 2 emissions.
Examples:
Purchased Electricity: Emissions from the generation of power that a business purchases from a utility company.
Purchased Steam or Heat: This refers to emissions produced during the generation of steam or heat that a business
purchases from a third party.
Impact on the Pharmaceutical Industry:
The energy requirements of pharmaceutical businesses' manufacturing processes, HVAC
systems, and laboratory operations are frequently considerable.
Increasing energy efficiency, making investments in renewable energy sources, and
acquiring green electricity or renewable energy certificates (RECs) are some ways
to reduce Scope 2 emissions.
Scope 3: Other Indirect Emissions
Definition: All other indirect emissions, including both upstream and downstream emissions that
take place along the reporting company's value chain, are included in Scope 3.
Examples:
Upstream Emissions:
Purchased Goods and Services: Purchased Goods and Services: Emissions from the manufacturing of components and
raw materials that the business uses.
Capital Goods: Emissions from the manufacturing of machinery and equipment that the business purchases.
Fuel and Energy-Related Activities: Emissions resulting from the manufacture and delivery of fuels and energy that the
business purchases.
Downstream Emissions:
Transportation and Distribution: Emissions resulting from the company's product distribution and transportation.
End-of-Life Treatment of Sold Products: Emissions from the company's handling and disposal of sold goods.
Franchises: Emissions from businesses that are not covered by Scopes 1 and 2.
Investments: The company's investment-related emissions, that is, significant energy requirements
for laboratory activities, HVAC systems, and industrial processes.
Net Zero Targets
The term “net zero targets” refers to the objectives set by businesses, nations, and
local governments to minimize their GHG emissions to almost zero, with any leftover
emissions being offset by initiatives to remove them, including carbon offset programs
or carbon capture technologies. According to the Paris Agreement, achieving Net Zero
is essential to keeping global warming to 1.5 or 2 °C over preindustrial levels.
Components of Net Zero Targets
Components of Net Zero Targets
1.
Emission Reduction
Scope 1 and 2 Emissions: It is necessary to drastically cut both direct and indirect emissions from owned
or controlled sources (such as manufacturing and energy usage) by implementing efficiency
improvements, converting to renewable energy, and installing fuel cells.
Scope 3 Emissions: Changes in product design, supplier involvement, and more environmentally friendly
business practices should all be used to address indirect emissions from the full
value chain (such as the supply chain and product consumption).
2.
Carbon Removal
Nature-Based Solutions: Initiatives that use soil carbon sequestration, afforestation, and reforestation
to absorb CO2 from the atmosphere organically.
Technological Solutions: Innovations that collect and store CO2 emissions from industrial processes or straight from the air, including direct air
capture (DAC) and carbon capture and storage (CCS).
3.
Offsets
Carbon Offsetting: Investing in initiatives that decrease or remove GHG emissions to compensate for
any leftover emissions that cannot be eradicated. Methane capture from landfills,
energy efficiency programs, and renewable energy projects are a few examples.
Innovation, Competitiveness, and Cost Efficiency
Innovation, Competitiveness, and Cost Efficiency
Innovation in pharmaceutical processes and products can be stimulated by adopting
a sustainable approach. Businesses can have a competitive advantage in the market
and draw in eco-aware customers by innovating to lessen their environmental impact.
Long-term cost reductions are possible when sustainable practices are implemented.
This entails cutting back on water and energy use, saving money on trash disposal,
and making the best use of available resources. To balance environmental responsibility
with corporate performance, pharmaceutical sustainability must prioritize innovation,
competitiveness, and cost-effectiveness.
Examples:
Implementing green chemistry principles to create safer, more efficient chemical processes
include using renewable raw materials, reducing solvent use, and designing for energy
efficiency.
Shifting from traditional batch processes to continuous manufacturing to enhance efficiency,
reduce waste, and lower energy consumption.
Utilizing biotechnological approaches to develop drugs with lower environmental impacts.
This includes biocatalysis, which uses natural catalysts, such as protein enzymes,
to perform chemical reactions under milder conditions.
Designing biodegradable or recyclable packaging and delivery systems to minimize waste
and environmental impact.
Leveraging sustainability initiatives to enhance brand reputation, attract environmentally
conscious consumers, and build investor confidence.
By integrating innovation, competitiveness, and cost efficiency into their sustainability
strategies, pharmaceutical companies can effectively reduce their environmental impact
while maintaining profitability and market leadership [7 ], [8 ].
Important Terminologies Related to Sustainability
Important Terminologies Related to Sustainability
Sustainable development in the pharmaceutical industry focuses on practices that ensure
long-term health benefits without compromising the environment or the ability of future
generations to meet their needs. The practices of sustainable development in the pharmaceutical
industry are crucial for minimizing environmental impacts, ensuring regulatory compliance,
and conserving resources. They drive economic efficiency by reducing waste and optimizing
resource use, enhance corporate social responsibility (CSR) and reputation, and improve
health and safety by reducing hazardous substances. Here are definitions of important
terms related to sustainable development in the pharmaceutical industry:
1.
Sustainable Development
Sustainable development refers to development that meets the needs of the present
without compromising the ability of future generations to meet their own needs. In
the pharmaceutical industry context, this involves balancing economic growth with
environmental protection and social responsibility.
2.
Green Chemistry
Green chemistry, also known as sustainable chemistry, involves designing chemical
products and processes that reduce or eliminate the use and generation of hazardous
substances. In pharmaceuticals, green chemistry principles aim to minimize environmental
impact during drug discovery, development, and manufacturing.
3.
Life Cycle Assessment (LCA)
Life cycle assessment is a technique used to assess the environmental impacts associated
with all stages of a product's life, from raw material extraction through production,
use, and disposal or recycling. In pharmaceuticals, LCA helps identify opportunities
to reduce environmental burdens across the product lifecycle.
4.
Circular Economy
The circular economy is an economic system aimed at minimizing waste and making the
most of resources. It involves designing products and processes to maximize resource
efficiency and promote reuse, recycling, and recovery of materials. In the pharmaceutical
industry, adopting circular economy principles can reduce waste generation and improve
resource efficiency.
5.
Corporate Social Responsibility
CSR refers to a company's commitment to operating ethically and responsibly while
contributing to economic development and improving the quality of life for its workforce,
their families, the local community, and society at large. In pharmaceuticals, CSR
includes initiatives related to sustainable practices, philanthropy, ethical marketing,
and social equity.
6.
Responsible Sourcing
Responsible sourcing involves ensuring that raw materials and products are ethically
and sustainably produced. In pharmaceuticals, responsible sourcing practices include
sourcing from suppliers who comply with environmental regulations, uphold human rights,
and promote fair labor practices.
7.
Eco-efficiency
Eco-efficiency refers to producing goods and services while using fewer resources
and creating less waste and pollution. In the pharmaceutical industry, eco-efficiency
focuses on improving resource efficiency, reducing energy and water consumption, and
minimizing environmental impact per unit of product manufactured.
8.
Regenerative Medicine
Regenerative medicine involves developing therapies that replace or regenerate human
cells, tissues, or organs to restore or establish normal function. In the context
of sustainability, regenerative medicine aims to develop treatments that are effective,
safe, and sustainable over the long term, minimizing adverse environmental and societal
impacts.
9.
Ethical Marketing Practices
Ethical marketing practices in the pharmaceutical industry involve promoting products
honestly, transparently, and responsibly, ensuring that marketing activities comply
with regulations and ethical guidelines. This includes avoiding misleading claims,
promoting evidence-based information, and respecting patient privacy and autonomy.
10.
Health Impact Assessment (HIA)
Health impact assessment is a tool used to assess the potential health effects of
policies, programs, or projects on populations. In pharmaceuticals, HIA can evaluate
the health impacts of drug development, manufacturing, and distribution processes,
ensuring that products contribute positively to public health outcomes.
11.
Sustainable Sourcing
It involves obtaining raw materials from suppliers who adhere to ethical and environmental
standards, ensuring that resources are responsibly managed and that the environmental
impact is minimized [9 ], [10 ], [11 ].
Sustainable practices foster innovation, competitiveness, and climate change mitigation
by reducing greenhouse gas emissions and promoting resource reuse. These terms also
address public health concerns, meet stakeholder demands, and ensure the long-term
viability of pharmaceutical companies by balancing economic, environmental, and social
considerations for a healthier planet and society.
Current Challenges in Material Sustainability
Current Challenges in Material Sustainability
Many organizations worldwide are increasingly prioritizing environmental sustainability,
sustainable human resource management, green human resource management, CSR, socially
responsible human resource management, employee green behavior, and innovative behavior.
This shift is driven by mounting pressure to mitigate the negative environmental impacts
of their operations and to comply with environmental regulations. Similar challenges
arise due to environmental issues such as climate change, global warming, pollution,
and the energy crisis. These factors compel enterprises to embrace green practices.
Additionally, globalization and consumer/customer demand for high-quality products
have compelled industries to enhance product standards. However, the historical focus
solely on economic rewards has resulted in the depletion of nonrenewable resources,
increased waste generation, and environmental pollution.
Nongovernmental organizations and stringent government regulations impose limits on
industries to protect the environment. These regulations prevent industries from violating
laws and releasing harmful emissions. In this complex situation, adopting advanced
paradigms that yield financial benefits while preserving the environment is crucial.
Industries must embrace innovative approaches to eco-friendly operations to maintain
their market presence amid increasing regulatory pressures [12 ], [13 ].
The challenges of increasing industrialization, population growth, and environmental
degradation of air, water, and land are alarming. Many developed countries struggle
to enact effective environmental regulations to combat escalating pollution while
developing countries face significant hurdles in enforcement.
In the pharmaceutical manufacturing sector to remain competitive and sustainable globally,
it must enhance its environmental and social performance. Failure to improve in these
areas jeopardizes its competitiveness and sustainability. Effective management practices
integrating environmental protection, social enhancement, and economic development
are essential for organizational success in this industry [14 ], [15 ].
The major current challenges in materials sustainability are described in [Fig. 3 ].
Figure 3 Major challenges in materials sustainability.
1.
Resource Depletion
Minerals, metals, and fossil fuels are among the many raw materials used by the pharmaceutical
industry for equipment manufacturing, medication synthesis, and packaging. Manufacturing
of advanced medical devices and diagnostic equipment requires critical secondary resources,
like rare earth elements. To lessen the depletion of resources, pharmaceutical businesses
must invest in recycling initiatives, alternative materials, and sustainable sourcing
practices. Business performance and environmental responsibility.
2.
Waste Generation
The production of pharmaceuticals produces a large amount of solid waste, which includes
leftover packaging, byproducts, and raw materials. This covers emissions that cause
pollution and environmental deterioration as well as solid waste and wastewater. Wastewater
containing solvents, other chemicals, and active pharmaceutical ingredients (APIs)
is frequently released throughout the production process. Pharmaceutical businesses
must implement more sustainable procedures in response to tightening rules around
waste management and disposal.
3.
Single-Use Plastics
Single-use plastics are widely used in the pharmaceutical industry to package products
including blister packs, bottles, and syringes. Single-use medical equipment and consumables
for laboratories are major sources of plastic waste. It is imperative for pharmaceutical
companies to investigate eco-friendly packaging options and encourage the utilization
of recyclable or degradable materials.
4.
Chemical Pollution
Solvents, reagents, and APIs are among the hazardous chemicals used in the pharmaceutical
production process. Pesticide pollution may be exacerbated by the pharmaceutical industry's
dependence on agricultural products (for biopharmaceuticals, for example). Best practices
in chemical management and the use of cleaner technology are required by strict restrictions
on chemical emissions and disposal.
5.
Climate Change Impact
Emissions of greenhouse gases are caused by the extraction, processing, and use of
materials in the production of pharmaceuticals. Setting and meeting aggressive GHG
reduction goals is necessary for pharmaceutical businesses to lessen the effects of
climate change. Businesses must create plans to mitigate the risks associated with
climate change, such as diversifying their supply chains and making investments in
dependable infrastructure.
6.
Ecosystem Degradation
Degradation of ecosystems affects natural products, which are the source of many medications.
To preserve ecosystems and biodiversity, pharmaceutical businesses need to make sure
that their sourcing processes are sustainable.
7.
Supply Chain Vulnerabilities
Global supply chains for pharmaceuticals are dependent on intermediates and raw materials
from different geographical areas. Pharmaceutical firms must have strong risk management
procedures that include supplier diversification and backup preparations [16 ], [17 ].
8.
Social and Economic Impacts
Material unsustainability frequently crosses paths with social problems like unequal
resource distribution, violations of workers' rights in extractive industries, and
unstable economies in resource-dependent countries. Workers in the pharmaceutical
sector and the communities around them may be exposed to dangerous substances and
toxins. This includes the chemicals used in the manufacturing of drugs, which can
cause long-term chronic illnesses, skin ailments, and respiratory problems, among
other health problems. Antibiotic resistance can result from improper disposal of
pharmaceutical waste, particularly antibiotic waste, which poses a serious risk to
public health. Managing pharmaceutical waste can be expensive, both in terms of treatment
and disposal. Stricter environmental rules and the requirement for cutting-edge waste
treatment technologies may result in increased costs for businesses.
Measures to Overcome Material Sustainability Challenges
Measures to Overcome Material Sustainability Challenges
The measures to overcome material sustainability challenges are described in [Table 1 ].
Table 1
Measures to overcome material sustainability challenges
S. no.
Measures
Examples
1.
Promote recycling, reducing and reusing waste
Implement extended producer responsibility (EPR)
2.
Promote use of renewable resources to maintain sustainability
Transition of renewable energy resources
3.
Enforcement of strict regulations on waste management and hazardous materials
Plastic waste bans and restrictions
4.
Encourage companies to reduce waste and invest in cleaner technologies
Adopt zero-waste policies and eco-friendly packaging
5.
Implementation of carbon taxes or Emissions Trading Systems. (ETS)
Set emission reduction targets for industries
6.
Encourage sustainable agriculture and forestry practices
Support organic farming and agroforestry
7.
Invest in water-efficient technologies and infrastructure
Implement smart water management systems
Analysis of Current Unsustainable Practices in Raw Materials Sourcing and Packaging
Analysis of Current Unsustainable Practices in Raw Materials Sourcing and Packaging
Currently, the practices surrounding raw materials sourcing and packaging are fraught
with unsustainable methods that pose significant environmental and social challenges.
In raw materials sourcing, industries often engage in practices that contribute to
deforestation, such as clearing land for agriculture or logging without sustainable
forest management.
For Example: The study suggests that the Novartis DPIs have on average a carbon footprint of less
than half compared to other published DPI LCAs. Classical pressurized metered-dose
inhalers (pMDIs) using HFC-134a as propellant gas can have on average a carbon footprint
of up to 50 times higher than the Novartis DPI. Novartis is committed to integrating
environmental LCAs into product development processes to embed sustainability by design,
supporting the delivery of the Novartis goals to achieve our climate targets.
This not only threatens biodiversity but also releases carbon stored in forests, exacerbating
climate change. Moreover, mining operations for metals and minerals frequently employ
techniques that result in habitat destruction, soil erosion, and water contamination,
harming local ecosystems and communities.
In packaging, the predominant use of single-use plastics contributes substantially
to global plastic pollution, with a large portion ending up in oceans and landfills,
where they persist for centuries and harm marine life. Excessive packaging, often
made from nonbiodegradable materials, adds to waste volumes and energy consumption
during production. Furthermore, inefficient logistics and transportation methods amplify
carbon emissions, as products and materials are transported over long distances using
fossil fuels [18 ], [19 ], [20 ].
These unsustainable practices not only strain natural resources but also compromise
the health and well-being of ecosystems and communities worldwide. The major practices
are shown in [Table 2 ].
Table 2
Current unsustainable practices in raw materials sourcing and packaging
S. no.
Factors
Description
1.
Raw materials sourcing
Deforestation: Many industries contribute to deforestation by sourcing raw materials such as palm
oil, timber, and soy without sustainable practices. This disrupts ecosystems and contributes
to climate change
Overfishing: Fisheries often exploit marine resources beyond sustainable limits, leading to declines
in fish populations and disrupting marine ecosystems
Mining: Extraction of minerals and metals often involves environmentally destructive practices
like open-pit mining, which can lead to habitat destruction, water pollution, and
soil erosion
2.
Packaging
Single-Use Plastics: Many products are still packaged in single-use plastics, which contribute significantly
to plastic pollution in oceans and landfills
Excessive Packaging: Products are sometimes over-packaged with materials that are not biodegradable or
recyclable, increasing waste generation
Energy Intensive Materials: Some packaging materials require high-energy inputs to produce, such as aluminum
and certain plastics, contributing to carbon emissions
Chemical Leachable from Packaging: Certain plasticizers and other chemicals used in packaging can leach into the pharmaceutical
products. These chemicals may have harmful effects on both the environment and human
health if not managed properly
3.
Transportation and distribution
Carbon Emissions: Long-distance transportation of raw materials and products contributes to carbon
emissions, especially when using fossil fuels
Inefficient Logistics: Inefficient transportation and distribution networks can lead to unnecessary energy
consumption and emissions
4.
Waste management
Landfilling: Many materials used in packaging and products end up in landfills instead of being
recycled or composted
Toxic Waste: Some industries generate hazardous waste that requires specialized disposal methods,
posing risks to ecosystems and human health
5.
Social impacts
Labor Practices: In some cases, raw material sourcing involves exploitative labor practices or poor
working conditions
Community Displacement: Large-scale extraction projects can lead to displacement of local communities and
loss of traditional livelihoods
6.
High carbon footprint
Sourcing raw materials from distant locations often requires significant transportation,
contributing to high carbon emissions. The pharmaceutical manufacturing process, including
the extraction and purification of raw materials, is often water-intensive along with
the use pharmaceuticals also involve solvents that are hazardous to the environment
in a significant amount
Social and Environmental Impacts on Material Sustainability
Social and Environmental Impacts on Material Sustainability
Social and environmental factors have a significant impact on material sustainability
across various industries and products. Here are some key points to consider as shown
in [Table 3 ], [21 ], [22 ].
Table 3
Social versus environmental impact on material sustainability.
S. no.
Social impact
Environmental impact
1.
Social Impact: Labor Practices: Ensuring fair wages, safe working conditions, and adherence to labor
laws contribute to social sustainability. Exploitative practices can harm communities
and lead to social unrest
Environmental Impact: Resource Efficiency: Sustainable materials use resources efficiently, minimizing
waste and reducing the overall environmental footprint of production processes
2.
Community Relations: Engaging with local communities, respecting their rights, and minimizing disruptions
from operations can enhance social acceptance and long-term sustainability
Carbon Footprint: The carbon emissions associated with extracting, processing, and transporting materials
contribute to climate change. Sustainable materials aim to reduce these emissions
through cleaner production methods and logistics
3.
Health and Safety: Materials that are hazardous during production, use, or disposal pose risks to workers
and communities. Sustainable materials prioritize safety and minimize health impacts
Pollution and Waste: Materials that release pollutants during production or generate hazardous waste contribute
to environmental degradation. Sustainable materials prioritize reducing pollution
and promoting circularity to minimize waste
4.
Supply Chain Ethics: Ethical sourcing practices, such as avoiding conflict minerals or unsustainable logging,
ensure that materials are sourced responsibly without contributing to social conflicts
or environmental degradation
Biodiversity: Extractive industries can threaten biodiversity through habitat destruction and pollution.
Sustainable materials aim to protect ecosystems and biodiversity hotspots
Emerging Trends and Innovations
Emerging Trends and Innovations
Material sustainability in the pharmaceutical industry focuses on the sustainable
management of materials throughout the lifecycle of pharmaceutical products. This
encompasses several key aspects as shown in [Fig. 4 ], [23 ], [24 ].
Figure 4 Trends and innovations in materials sustainability.
Overall, material sustainability in the pharmaceutical industry is integral to reducing
environmental impact, enhancing operational efficiency, meeting regulatory requirements,
and fostering long-term business resilience. It aligns environmental stewardship with
corporate responsibility, benefiting both the industry and global sustainability efforts.
Recent Sustainability Trends
Recent Sustainability Trends
1.
Reality of Approaching Targets Begins to Set
Many companies have taken step toward maintaining the sustainability by adopting the
Net Zero Commitments and emissions reduction targets. They are continuously taking
steps toward achieving such targets.
2.
Sustainable Investing
Market Share to Hold Steady; Climate Comes into Focus for Indexes Sustainable funds
experienced diminished flows throughout 2023 due in part to the challenging macro
environment. Expect volumes to remain at similar levels with greater investor focus
on “Climate” and “Transition” related themes instead of “ESG”.
3.
Consistent Demand for Sustainable Loans Remains Amid Market Volatility
The sustainable use of proceeds and sustainability-linked loan (SLL) market is expected
to expand, with 2024 being a significant year for the integration of KPIs into credit
agreements via an amendment approach (“sleeping” SLLs).
4.
Carbon Markets
A Mixed Bag While COP28 failed to deliver a global carbon market, voluntary markets
are coalescing around emerging principles to establish quality, credibility, and transparency
in carbon credits.
5.
Nature
New Vocabulary and Complex Compliance Nature will continue to garner attention as
a developing topic with proposed disclosure frameworks.
Regulatory Framework and Compliance
Regulatory Framework and Compliance
WHO has formulated international regulatory standards, which include stability, packaging,
storage, and bioequivalence. It is important to take precautions to guarantee that
active medicinal ingredients are stable and unaffected by storage or packaging materials.
Furthermore, considering that the World Health Organization supports generic drugs
and that they may make vital medications more accessible, the creation of bioequivalence
criteria between originator and generic medications is crucial.
Internationally , sustainability in the pharmaceutical sector is guided by several key standards and
frameworks. ISO 14001 is a cornerstone, providing a framework for environmental management
systems that help organizations minimize their environmental impact and ensure compliance
with applicable regulations. It sets out criteria for identifying, managing, and improving
environmental performance, which pharmaceutical companies leverage to achieve sustainable
operations. Similarly, Good Manufacturing Practices (GMP) are not only about ensuring
product quality but now also integrating sustainable practices such as waste minimization
and energy efficiency into manufacturing processes. The International Council for
Harmonisation (ICH) further strengthens this approach with guidelines like ICH Q11,
which emphasize the sustainable development and manufacture of drug substances. These
guidelines ensure that companies adopt practices that reduce environmental impact
throughout
the product lifecycle [25 ], [26 ].
Regionally , regulations vary but consistently aim to enforce stringent environmental standards.
In the EU , the REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals)
regulation is pivotal. It requires companies to register chemicals and assess their
safety, thereby reducing the risk posed by hazardous substances. Additionally, the
European Medicines Agency (EMA) mandates environmental risk assessments (ERA) for
pharmaceuticals, ensuring that companies evaluate and mitigate the environmental impacts
of their products from development to disposal. The EU Green Deal further pushes pharmaceutical
companies toward achieving a circular economy by encouraging the use of sustainable
materials and reducing carbon footprints (2). Several OECD countries have developed
specific guidelines and frameworks for sustainable forest management (SFM). These
guidelines are designed to ensure that forests are managed in an environmentally responsible,
socially
beneficial, and economically viable manner. Here are some examples of guidelines and
practices from various OECD countries. For Example : Canada’s National Forest Strategy outlines the principles and practices for SFM
across the country. Implementing sustainable harvesting techniques. Conducting environmental
impact assessments. Monitoring and reporting on forest health and sustainability.
In the United States , the regulatory framework is governed by the Environmental Protection Agency (EPA)
and the Food and Drug Administration (FDA). The Toxic Substances Control Act (TSCA)
regulates the use of chemicals, requiring extensive testing and reporting to prevent
environmental harm. The FDA’s environmental impact regulations necessitate that new
drug applications include a comprehensive environmental assessment, ensuring that
potential impacts on ecosystems and human health are considered and mitigated(3).
In the Asia-Pacific region, countries like China and Japan have stringent laws to enforce sustainable
practices. China’s Environmental Protection Law mandates comprehensive measures for
pollution control and sustainable resource management, requiring pharmaceutical companies
to adhere to high standards of environmental stewardship. Japan’s Chemical Substances
Control Law regulates the production and use of chemicals to prevent pollution and
ensure
safety, requiring rigorous assessments and compliance to minimize environmental impacts.
India has implemented various laws and regulations that address sustainability across
different sectors, including environmental protection, resource management, and sustainable
development. India’s legal and regulatory framework for sustainability includes a
range of laws and policies aimed at environmental protection, resource management,
and sustainable development. These laws address critical areas such as forest conservation,
wildlife protection, energy efficiency, and waste management, contributing to the
country’s broader sustainability goals [27 ], [28 ].
Sustainable sourcing involves obtaining raw materials from suppliers who adhere to ethical and environmental
standards, ensuring that resources are responsibly managed and that the environmental
impact is minimized. Green chemistry principles guide the design of chemical processes
that reduce or eliminate the use of hazardous substances and minimize waste generation.
This approach promotes the development of safer, more efficient production methods
that reduce environmental impacts and enhance sustainability. Use resources such as
energy, water, and raw materials efficiently to minimize waste and reduce the environmental
footprint. Evaluate and reduce the environmental impact of products and services,
including aspects such as emissions, pollution, and habitat destruction [29 ], [30 ].
Discussion on Existing Regulations and Guidelines Governing Materials Sustainability
in the Pharmaceutical Sector
Discussion on Existing Regulations and Guidelines Governing Materials Sustainability
in the Pharmaceutical Sector
Materials sustainability in the pharmaceutical industry is governed by a complex web
of regulations and guidelines designed to minimize environmental impact, ensure safe
and responsible use of chemicals, and promote sustainable practices throughout the
lifecycle of pharmaceutical products. This discussion explores the key regulations
and guidelines that influence how pharmaceutical companies manage materials and maintain
sustainability in their operations [31 ].
1.
International Guidelines and Standards
ISO 14001: Environmental Management Systems
ISO 14001 is a globally recognized standard that provides a framework for organizations
to create an effective environmental management system (EMS). It helps pharmaceutical
companies identify and manage environmental risks, ensure legal compliance, and improve
resource efficiency. The standard emphasizes a systematic approach to reducing waste,
conserving energy, and minimizing the environmental footprint of manufacturing processes.
By adhering to ISO 14001, pharmaceutical companies can demonstrate their commitment
to environmental stewardship and meet the expectations of stakeholders and regulators
alike [32 ].
Good Manufacturing Practice (GMP)
GMP guidelines, established by regulatory agencies like the FDA in the United States
and the EMA in Europe, are critical for ensuring the quality and safety of pharmaceutical
products. While traditionally focused on product quality, GMP guidelines are increasingly
incorporating sustainability aspects, such as reducing the use of hazardous materials
and implementing waste management practices. For instance, GMP now often includes
requirements for energy-efficient processes, environmentally friendly production methods,
and responsible waste disposal. This shift reflects a broader recognition of the need
to balance product safety and quality with environmental sustainability [33 ].
ICH Guidelines
The ICH, which harmonizes technical requirements for pharmaceuticals across major
markets, includes guidelines that touch on sustainability. For example, ICH Q11, which
covers the development and manufacture of drug substances, includes principles related
to the sustainable use of resources and the minimization of environmental impacts
during drug production. These guidelines encourage pharmaceutical companies to adopt
more sustainable practices and reduce their environmental footprint, aligning with
global efforts to promote sustainable development in the industry [34 ].
Global Reporting Initiative (GRI) Standards
The GRI provides a comprehensive framework for sustainability reporting, allowing
companies to disclose their environmental, social, and governance (ESG) impacts. For
the pharmaceutical industry, GRI standards offer guidance on reporting the sustainability
of materials, including the sourcing of raw materials, energy use, waste management,
and emissions. By adhering to GRI standards, pharmaceutical companies can enhance
transparency and accountability in their sustainability practices, meeting the growing
demand from stakeholders for responsible corporate behavior [35 ].
2.
Regional Regulations
EU Regulations
REACH
REACH is a critical regulation in the EU that governs the production and use of chemical
substances. It requires companies to register chemicals used in their products and
manufacturing processes, conduct risk assessments, and ensure safe handling and disposal.
For the pharmaceutical industry, REACH imposes stringent requirements on the use of
hazardous substances and promotes the substitution of dangerous chemicals with safer
alternatives. This regulation helps reduce the environmental impact of pharmaceutical
manufacturing and encourages the development of greener, more sustainable materials
[36 ], [37 ].
EMA Environmental Risk Assessment
The EMA requires pharmaceutical companies to conduct an ERA for medicinal products.
This assessment evaluates the potential environmental impacts of pharmaceuticals,
from production through to disposal. Companies must identify and mitigate risks such
as contamination of water sources, soil pollution, and adverse effects on wildlife.
The ERA process promotes the responsible use of materials and encourages companies
to adopt more sustainable practices, ensuring that the environmental impact of pharmaceuticals
is minimized throughout their lifecycle [38 ], [39 ].
United States Regulations
Toxic Substances Control Act (TSCA)
The TSCA regulates the production, importation, and use of chemical substances in
the United States. It requires companies to provide data on the environmental and
health impacts of chemicals and to comply with restrictions on hazardous substances.
For the pharmaceutical industry, TSCA compliance involves ensuring that chemicals
used in drug production do not pose unreasonable risks to health or the environment.
This regulation promotes the safe and sustainable use of materials and encourages
the development of less harmful substances and processes [40 ], [41 ].
FDA Environmental Impact Regulations
The FDA requires an environmental assessment (EA) for new drug applications, biologics
license applications, and other product filings. The EA evaluates the potential environmental
impacts of pharmaceuticals, including resource use, emissions, and waste disposal.
Companies must demonstrate that their products and processes are environmentally responsible
and comply with relevant regulations. This requirement helps ensure that pharmaceutical
companies consider the environmental implications of their operations and take steps
to minimize their impact [42 ], [43 ],
Asia-Pacific Regulations
China’s Environmental Protection Law
China’s Environmental Protection Law imposes strict requirements on pollution control
and sustainable resource use. Pharmaceutical companies operating in China must comply
with regulations on emissions, waste management, and the use of hazardous substances.
This law encourages companies to adopt sustainable practices, such as reducing energy
consumption and minimizing waste, to protect the environment and promote public health.
Compliance with these regulations is essential for companies looking to operate sustainably
in China’s rapidly growing pharmaceutical market [44 ], [45 ].
Japan’s Chemical Substances Control Law
Japan’s Chemical Substances Control Law
Japan’s Chemical Substances Control Law regulates the production, importation, and
use of chemical substances to prevent pollution and ensure safety. Pharmaceutical
companies must register chemicals, perform risk assessments, and comply with restrictions
on hazardous substances. This regulation promotes the safe and sustainable use of
materials and encourages companies to develop more environmentally friendly products
and processes. By complying with Japan’s stringent regulations, pharmaceutical companies
can demonstrate their commitment to sustainability and environmental protection [46 ], [47 ].
Future Directions in Materials Sustainability
Future Directions in Materials Sustainability
Despite these efforts, the pharmaceutical industry faces several challenges in achieving
materials sustainability. The complexity of global regulations can be overwhelming,
requiring significant resources to ensure compliance across different regions. Balancing
the cost of implementing sustainable practices with operational and financial constraints
remains a critical issue, particularly for small and medium-sized enterprises. Managing
sustainability across a diverse and global supply chain adds another layer of complexity,
as it involves coordinating with multiple suppliers and stakeholders with varying
practices and standards.
Looking forward, the integration of digital technologies offers promising solutions
for enhancing sustainability compliance. Tools like blockchain can provide transparency
and traceability in supply chains, while artificial intelligence can help predict
compliance issues and optimize sustainability practices. Innovation in sustainable
materials will continue to be crucial, driving the development of new, eco-friendly
substances and processes that reduce the environmental footprint of pharmaceuticals.
Additionally, efforts toward the global harmonization of regulations could simplify
compliance and promote a more consistent and effective approach to sustainability
across the industry [48 ], [49 ].
The regulatory framework for materials sustainability in the pharmaceutical industry
is evolving to meet the increasing demands for environmental and social responsibility.
By adhering to these regulations and adopting proactive compliance strategies, pharmaceutical
companies can not only fulfill legal requirements but also contribute significantly
to global sustainability goals, fostering a more sustainable and responsible future
for the industry and society at large [50 ].
Practical Recommendations for Stakeholders in the Industry
Practical Recommendations for Stakeholders in the Industry
To effectively implement sustainable practices in the pharmaceutical industry, stakeholders—including
companies, suppliers, regulators, and consumers—must take specific actions.
Pharmaceutical Companies
Implementing sustainable practices starts with pharmaceutical companies taking the
lead through the development and implementation of robust sustainable policies. By
setting clear sustainability goals, creating comprehensive roadmaps, and conducting
regular audits, companies ensure accountability and track progress toward reducing
their environmental footprint. Investing in green technologies, such as energy-efficient
equipment and renewable energy sources, further enhances sustainability efforts by
reducing energy consumption and carbon emissions. Fostering a culture of sustainability
within the organization through employee training, cross-departmental teams, and leadership
commitment is essential for embedding sustainable practices into daily operations
[51 ], [52 ].
Suppliers
Suppliers play a crucial role in the pharmaceutical supply chain by adopting sustainable
practices in materials sourcing and manufacturing. By sourcing responsibly, using
eco-friendly materials, and obtaining relevant certifications, suppliers can align
with pharmaceutical companies’ sustainability goals and contribute to overall industry
sustainability. Collaborating closely with pharmaceutical partners and other stakeholders
ensures that sustainable practices are integrated throughout the supply chain, promoting
transparency and accountability in sourcing and manufacturing processes [53 ].
Regulators and Policymakers
Regulators and policymakers are instrumental in promoting sustainability through the
establishment and enforcement of regulations that govern the pharmaceutical industry.
Developing clear guidelines, enforcing compliance with environmental standards, and
incentivizing sustainable practices ensure that industry operations align with global
sustainability goals. By fostering a regulatory environment that supports innovation
in green technologies and practices, policymakers can drive industry-wide adoption
of sustainable initiatives and contribute to a more sustainable healthcare system
[54 ].
Healthcare Providers and Pharmacies
Healthcare providers and pharmacies can promote sustainability by prioritizing sustainable
products and practices within their facilities. By sourcing pharmaceuticals from companies
that adhere to sustainable practices, healthcare providers can reduce their environmental
impact. Implementing green practices, such as waste reduction strategies and energy-efficient
operations, further supports sustainability efforts in healthcare settings. Educating
patients on the environmental impact of pharmaceutical choices and encouraging proper
disposal of medications also play a crucial role in promoting sustainable healthcare
practices. Proper disposal of expired medicines is crucial to ensure environmental
protection, public health, and safety. Improper disposal can lead to contamination
of water supplies and soil and harm wildlife, as well as pose risks to human health
if medications are misused or accidentally ingested. Expired medicines, if not disposed
of correctly, can leach
harmful chemicals into the environment, contaminating soil and water sources. Chemicals
from expired medicines can adversely affect wildlife and aquatic ecosystems, causing
harm to various species. Proper disposal prevents expired medicines from being misused
or accidentally ingested by individuals, particularly children.
Pharmacy Take-Back Programs
Many pharmacies offer take-back programs where individuals can return expired or unused
medicines for proper disposal [54 ].
Consumers and Patients
Consumers and patients contribute to sustainability in the pharmaceutical industry
by making informed choices and adopting eco-friendly behaviors. Choosing pharmaceutical
products from companies that prioritize sustainability and properly disposing of medications
following guidelines helps reduce environmental impact. Participating in medication
take-back programs and supporting initiatives that promote sustainable healthcare
practices further contribute to environmental stewardship and support the shift toward
a more sustainable pharmaceutical industry [55 ].
Researchers and Academics
Researchers and academics drive innovation in sustainable practices by conducting
research on the environmental impact of pharmaceuticals and developing green technologies
and processes. By focusing on sustainable research, they identify opportunities to
reduce environmental footprint and improve sustainability across the pharmaceutical
lifecycle. Integrating sustainability into pharmaceutical education prepares future
professionals to incorporate green practices into their work, fostering a culture
of environmental responsibility and innovation in the industry [56 ].
Future Research Directions
Future Research Directions
Future research should focus on conducting comprehensive LCAs to identify and mitigate
environmental impacts throughout product life cycles. Research should also explore
sustainable synthesis methods through green chemistry, adopt circular economy principles
for recycling and reusing materials, investigate renewable and biodegradable packaging
alternatives, assess the sustainability of emerging technologies like nanotechnology
and 3D printing, enhance supply chain transparency using blockchain, understand consumer
behavior toward sustainable products, evaluate policy effectiveness, promote collaborative
initiatives, and conduct rigorous risk assessments for environmental and health impacts.
These efforts help in advancing environmental responsibility and innovation in pharmaceutical
manufacturing and distribution [57 ], [58 ].
Conclusion
In conclusion, the review highlights a critical need for concerted efforts toward
environmental responsibility and innovation. Pharmaceutical companies, suppliers,
regulators, healthcare providers, consumers, researchers, and academics all play integral
roles in promoting sustainable practices throughout the industry. By implementing
robust policies, investing in green technologies, and fostering a culture of sustainability,
stakeholders can significantly reduce the industry’s environmental footprint. Collaboration
among stakeholders is essential for developing and adhering to regulations that promote
sustainable sourcing, manufacturing, and packaging practices. Ultimately, by prioritizing
sustainability in materials sourcing and operations, the pharmaceutical industry can
contribute to global sustainability goals while ensuring a healthier future for both
healthcare and the environment.
Bibliographical Record
