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
