The Green Pharmaceutical Transition

Words by Sadhana Dahal
Sadhana Dahal earned her PharmD from Punjab University, Pakistan. Embarking on an academic career, she lectured in Pharmacy at Asian College for Advanced Studies. Recognizing the need for further education, she pursued an M.Phil. in Pharmaceutical Chemistry from the same Pakistani university. She taught Pharm. D students at Punjab University, focusing on organic and analytical chemistry, before returning to Nepal in March 2018. Joining Nepal Army Institute of Health Sciences, she served for 3 years, and currently works as a pharmacy officer in the National Medicine Laboratory’s method validation department. In this role, Sadhana contributes to routine drug product analysis, reviews method validation protocols, and ensures compliance with regulatory standards. She aspires to lead as a team leader, fostering the laboratory’s commitment to quality and safety in drug production in Nepal and other low-income nations.

The pharmaceutical industry plays a crucial role in global healthcare by discovering, developing, producing, and marketing medications to treat and prevent diseases. However, its operations significantly impact human health and the environment. The industry contributes to a large carbon footprint through energy-intensive manufacturing processes and global supply chains, leading to greenhouse gas emissions. Pharmaceuticals and personal care products, including antimicrobial agents, hormones, and disinfectants, are increasingly found in water, soil, and wastewater, raising serious health concerns. Many researchers are continuously working to assess chronic effects linked to pharmaceutical and personal care products on ecology and human health due to their occurrence and persistence in aquatic and soil environments (1). Significant quantities of chemical waste are generated during production, and around 30 to 90 percent of active ingredients in drugs are excreted unchanged, entering the environment through sewage. (2) To ensure access to medicines for a growing population while protecting the planet, the industry must adopt sustainable practices. This involves reducing waste, using less toxic materials, and improving energy efficiency, aiming for zero emissions and waste—an ideal we must strive toward. Ideally the goal should be to assure access to high-quality medicines for all while having zero emissions and waste generated. This is more a vision than reality at the moment, but we can and have to work towards this direction.

Nepal’s Pharmaceutical Industry: Current Challenges
In the global scenario, sourcing of the sustainable raw materials, including active pharmaceutical ingredients (APIs) and excipients, proves challenging due to its sophisticated supply chains involving multiple suppliers. Another large issue is related to its transportation where finding eco-friendly shipping options remain difficult and costly. Nepal’s pharmaceutical industry has seen its substantial growth over the years, driven by increasing demand for medicines. However, the industry faces several challenges related to environmental sustainability:
1. Limited Infrastructure and Technology: Nepal’s pharmaceutical sector is characterized by a range of small to medium-sized enterprises with varying levels of technological advancement. Many companies operate with limited resources which can hinder their ability to implement green practices. Upgrading infrastructure and investing in advanced technologies are essential steps for adopting sustainable manufacturing processes.
2. Lack of Regulatory Framework: Nepal has made significant progress in environmental regulation, but the framework for overseeing green practices within the pharmaceutical industry remains in its early stages. There is a greater need for more detailed regulations that target pharmaceutical manufacturing and waste management. Furthermore, implementing incentives for adopting eco-friendly practices could motivate more companies to embrace sustainable methods.
3. Lack of Awareness and Education: Awareness of green pharmaceutical practices among industry stakeholders in Nepal is relatively low. There is a need for greater education and training on the benefits and implementation of sustainable practices. Raising awareness can help foster a culture of sustainability within the industry.

Opportunities for Advancing the Green Pharmaceutical Transition in Nepal
Despite the challenges, there are significant opportunities for Nepal to advance the green pharmaceutical transition:

1. Government Initiatives and Policies: The Nepalese government has expressed commitment to environmental sustainability through Article 30(1) of the Constitution 2072 which guarantees the right to live in a clean and healthy environment. By integrating green pharmaceutical practices into national environmental policies, the government can provide a supportive framework for the industry. Policies should include incentives or certification for adopting green technologies, stricter regulations on waste management, and support for research and development in green chemistry.

2. International Collaboration: Nepal can benefit from partnerships with international organizations and companies that are leading the way in green pharmaceuticals. Collaborations can provide access to advanced technologies, best practices, and funding opportunities. Engaging with global initiatives and networks can help Nepalese companies stay more updated with international trends and innovations in sustainable practices or may move towards better natural alternative

3. Innovation and Research: Investing in local research and innovation and involving academia is crucial for developing green pharmaceutical practices that are tailored to Nepal’s specific needs. Supporting research institutions, startups, and industry partnerships can drive innovation in green chemistry, sustainable manufacturing, and waste management. Research initiatives can also focus on developing eco-friendly drug formulations and processes that reduce environmental impact.

4. Educational Programs and Training: Developing educational programs; and training initiatives focused on green pharmaceutical practices can enhance industry knowledge and capabilities. Training programs for industry professionals, including manufacturers, regulators, and researchers, can help build expertise in sustainable practices and promote the adoption of green technologies.

Global initiatives: Lessons to learn from Sweden and the USA
Efforts to reduce the pharmaceutical industry’s environmental impact include adopting greener manufacturing practices, cutting down on waste, and following strict regulations. Sweden and the USA are leading with notable initiatives. In Sweden, a trial being started in 2024 will reward the production of environmentally friendly drugs, focusing on sex hormones, antibiotics, and anti-inflammatory medicines. Meanwhile, in the USA, the Environmental Protection Agency (EPA) has set guidelines to handle certain drugs as hazardous waste and enforce special disposal methods. The “Secure and Responsible Drug Disposal Act” further promotes safe drug disposal to protect the environment and public health. Moreover, Evonik Health Care has set the goal of achieving carbon neutrality by 2030 via green energy, efficiency, and Green Chemistry.

Conclusion:
Addressing waste reduction in drug manufacturing is not an easy job. It requires substantial changes to processes and investments, where many stakeholders may resist the process due to the need to balance economic considerations with sustainability goals. Reducing energy consumption in drug development and manufacturing may add another layer of complexity to older facilities that aren’t equipped to shift to renewable energy sources. For them the high initial costs of these changes can impact product pricing and competitiveness in the market. Aligning with regulatory authorities for sustainable practice is again a difficult move. But there is no other alternative other than moving in this direction. There is an urgent need to develop and implement novel innovative strategies to avoid the mismanagement of pharmaceutical waste. For this educational institutions must include pharmaceutical waste management in their curriculum to create awareness about the harmful effects of improper waste management in nature. Earth is not just our home. It is the home of every being that exists here. Thus we have to take responsibility not only for the quality of the manufactured pharmaceuticals but also for the footprint of our manufacturing processes on this planet. The path forward involves a collaborative effort from the government, industry stakeholders, and the community. Balancing quality, environmental, cost and timeline aspects in pharmaceutical development programs is highly complex but we should keep in mind that the green pharmaceutical transition is not just an option rather a necessary evolution towards a more sustainable future. For Nepal, this transition represents a critical opportunity to enhance the sustainability of its pharmaceutical industry, protect its rich natural resources, and contribute to global environmental goals.

References.
1.Chaturvedi, P., Shukla, P., Giri, B. S., Chowdhary, P., Chandra, R., Gupta, P., & Pandey, A. (2021). Prevalence and hazardous impact of pharmaceutical and personal care products and antibiotics in environment: A review on emerging contaminants. Environmental research, 194, 110664.
2.https://www.pharmaceutical-technology.com/comment/commentgreen-pharma-the-growing-demand-for-environmentally-friendly-drugs-5937344/
3.https://www.cornerstone-group.com/2024/04/12/green-pharma-how-the-pharmaceutical-industry-is-embracing-sustainability/
4.Alhoperah, G. H., Almaghthawi, S. O., Alrizq, M. O. M., Al Sulayyim, A. H., Alshammari, M. M., Al-Swedan, H. Y. H., … & Alenazi, M. S. F. (2023). Sustainability In Pharma-Green Initiatives And Environmental Responsibility. Journal of Namibian Studies: History Politics Culture, 36, 1942-1952.

 

 

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