Improving the Quality Assurance of Organic Drugs Production Challenge and Solutions

Issue

Vol. 13 No. 2 (2025): 2025 Volume -13 - Issue 2

Date Log

Published
June 29, 2025
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Improving the Quality Assurance of Organic Drugs Production Challenge and Solutions

https://doi.org/10.61096/ijamscr.v13.iss2.2025.301-318
Zukaa Mansoura
Department of Quality Assurance, Mewar University. Gangrar, Chittorgarh, Rajasthan-312901
Tanya Sharma
Faculty of Pharmaceutical Sciences, Mewar University. Gangrar, Chittorgarh, Rajasthan- 312901
Pankaj Chasta
Faculty of Pharmaceutical Sciences, Mewar University. Gangrar, Chittorgarh, Rajasthan- 312901

Corresponding Author(s) : Zukaa Mansoura

tanyasharma@mewaruniversity.co.in

International Journal of Allied Medical Sciences and Clinical Research, Vol. 13 No. 2 (2025): 2025 Volume -13 - Issue 2

Abstract

Background: Natural drugs are widely used in the industry, more than 60% of drugs are their derivatives, so the production of organic drugs has become more and more important; but it also has many challenges, especially quality assurance. For the health of consumers and to uphold regulatory standards, ensuring the safety and efficacy of these drugs is paramount. The objective of this paper is to show the need for a more robust quality assurance system in the organic drug response.


Objective: This research aims to find the influential factors concerning the quality assurance of organic pharmaceuticals and provide some solutions for improving these measures. The study seeks to address the problems which are tried in this industry towards building strong quality assurance frameworks.


Approach: This study utilizes a mixed-methods methodology, integrating experimental analysis and stakeholder-oriented qualitative evaluation. Such an approach gives a holistic perspective on the quality assurance scenario in organic drug manufacturing. To provide practical recommendations for improvement, the research has an extensive analysis of quality control methodologies, regulatory challenges, and sustainable development strategies.


Results: The study outlined challenges faced in the quality assurance of organic drugs, including insufficient regulatory frameworks and a lack of standardized quality control processes. The study reveals key parameters that affect the quality control, including selection of extraction techniques and conditions of production of organic drugs.


Conclusion: This study emphasizes the significance of stringent quality assurance behaviour in organic medicaments, the study aims at improving the quality and safety of the organic pharmaceuticals by addressing the mentioned challenges and forthcoming actionable solutions. These research findings are anticipated to be beneficial to the stakeholders in the pharmaceutical sector that will help bolster practices as well as consumer outcomes.

Keywords

Organic Drugs Quality Assurance Regulatory Challenges Biotechnological Advancements Analytical Techniques
1.
Zukaa Mansoura, Tanya Sharma, Pankaj Chasta. Improving the Quality Assurance of Organic Drugs Production Challenge and Solutions. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2025 Jun. 29 [cited 2026 Apr. 16];13(2):301-18. Available from: https://ijamscr.com/ijamscr/article/view/1631
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX
References
  1. Adulapuram Aroon, Akuthota Kavya, Mudhadapu Swetha rani, Mandapati Harshitha, & Nagula Anannya. (2024). Evolution of quality assurance in pharmaceutical industry. World Journal of Biology Pharmacy and Health Sciences, 20(2), 656–661. https://doi.org/10.30574/wjbphs.2024.20.2.0937
  2. Alegbeleye, O. O., Singleton, I., & Sant’Ana, A. S. (2018). Sources and contamination routes of microbial pathogens to fresh produce during field cultivation: A review. Food Microbiology, 73, 177–208. https://doi.org/10.1016/j.fm.2018.01.003
  3. Ali, F., & Nollet, L. M. L. (2024). Global Regulations of Medicinal, Pharmaceutical, and Food Products. CRC Press. https://doi.org/10.1201/9781003296492
  4. Avigan, M., Mozersky, R., & Seeff, L. (2016). Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States. International Journal of Molecular Sciences, 17(3), 331. https://doi.org/10.3390/ijms17030331
  5. Awlqadr, F. H., Majeed, K. R., Altemimi, A. B., Hassan, A. M., Qadir, S. A., Saeed, M. N., Faraj, A. M., Salih, T. H., Abd Al‐Manhel, A. J., Najm, M. A. A., Tsakali, E., Van Impe, J. F. M., Abd El-Maksoud, A. A., & Abedelmaksoud, T. G. (2025). Nanotechnology-based herbal medicine: Preparation, synthesis, and applications in food and medicine. Journal of Agriculture and Food Research, 19, 101661. https://doi.org/10.1016/j.jafr.2025.101661
  6. Borges, C. V., Minatel, I. O., Gomez-Gomez, H. A., & Lima, G. P. P. (2017). Medicinal Plants: Influence of Environmental Factors on the Content of Secondary Metabolites. In Medicinal Plants and Environmental Challenges (pp. 259–277). Springer International Publishing. https://doi.org/10.1007/978-3-319-68717-9_15
  7. Chaachouay, N., & Zidane, L. (2024). Plant-Derived Natural Products: A Source for Drug Discovery and Development. Drugs and Drug Candidates, 3(1), 184–207. https://doi.org/10.3390/ddc3010011
  8. Chandra, S., Khan, S., Avula, B., Lata, H., Yang, M. H., ElSohly, M. A., & Khan, I. A. (2014). Assessment of Total Phenolic and Flavonoid Content, Antioxidant Properties, and Yield of Aeroponically and Conventionally Grown Leafy Vegetables and Fruit Crops: A Comparative Study. Evidence-Based Complementary and Alternative Medicine, 2014, 1–9. https://doi.org/10.1155/2014/253875
  9. Chen, Y.-G., He, X.-L.-S., Huang, J.-H., Luo, R., Ge, H.-Z., Wołowicz, A.,Wawrzkiewicz, M., Gładysz-Płaska, A., Li, B., Yu, Q.-X., Kołodyńska, D., Lv, G.-Y., & Chen, S.-H. (2021). Impacts of heavy metals and medicinal crops on ecological systems, environmental pollution, cultivation, and production processes in China. Ecotoxicology and Environmental Safety, 219, 112336. https://doi.org/10.1016/j.ecoenv.2021.112336
  10. Deschamps, E., Calabrese, V., Schmitz, I., Hubert-Roux, M., Castagnos, D., & Afonso, C. (2023). Advances in Ultra-High-Resolution Mass Spectrometry for Pharmaceutical Analysis. Molecules (Basel, Switzerland),28(5). https://doi.org/10.3390/molecules28052061
  11. Dubale, S., Kebebe, D., Zeynudin, A., Abdissa, N., & Suleman, S. (2023). Phytochemical Screening and Antimicrobial Activity Evaluation of Selected Medicinal Plants in Ethiopia. Journal of Experimental Pharmacology, Volume 15, 51–62. https://doi.org/10.2147/JEP.S379805
  12. Eapen, J. V., Thomas, S., Antony, S., George, P., & Antony, J. (2024). A review of the effects of pharmaceutical pollutants on humans and aquatic ecosystem. Exploration of Drug Science, 484–507. https://doi.org/10.37349/eds.2024.00058
  13. Ekor, M. (2014). The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Frontiers in Pharmacology, 4. https://doi.org/10.3389/fphar.2013.00177
  14. George, S., & Elrashid, S. (2023). Inventory Management and Pharmaceutical Supply Chain Performance of Hospital Pharmacies in Bahrain: A Structural Equation Modeling Approach. Sage Open, 13(1). https://doi.org/10.1177/21582440221149717
  15. Guner, S., & Topalcengiz, Z. (2018). Effect of Pulsed Ultraviolet Light on Natural Microbial Load and Antioxidant Properties of Fresh Blueberries. Turkish Journal of Agriculture - Food Science and Technology, 6(6), 733–739. https://doi.org/10.24925/turjaf.v6i6.733-739.1797
  16. Jordan, S. A., Cunningham, D. G., & Marles, R. J. (2010). Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment. Toxicology and Applied Pharmacology, 243(2), 198–216. https://doi.org/10.1016/j.taap.2009.12.005
  17. Kumar, M., Bhatia, R., & Rawal, R. K. (2018). Applications of various analytical techniques in quality control of pharmaceutical excipients. Journal of Pharmaceutical and Biomedical Analysis, 157, 122–136. https://doi.org/10.1016/j.jpba.2018.05.023
  18. Kunle. (2012). Standardization of herbal medicines - A review. International Journal of Biodiversity and Conservation, 4(3). https://doi.org/10.5897/IJBC11.163
  19. Li, C.-Q., Lei, H.-M., Hu, Q.-Y., Li, G.-H., & Zhao, P.-J. (2021). Recent Advances in the Synthetic Biology of Natural Drugs. Frontiers in Bioengineering and Biotechnology, 9. https://doi.org/10.3389/fbioe.2021.691152
  20. Mo rlock, G. E. (2021). High-performance thin-layer chromatography combined with effect-directed assays and high-resolution mass spectrometry as an emerging hyphenated technology: A tutorial review. Analytica Chimica Acta, 1180, 338644. https://doi.org/10.1016/j.aca.2021.338644
  21. Moualek, I., Iratni Aiche, G., Mestar Guechaoui, N., Lahcene, S., & Houali, K. (2016). Antioxidant and anti-inflammatory activities of Arbutus unedo aqueous extract. Asian Pacific Journal of Tropical Biomedicine, 6(11), 937–944. https://doi.org/10.1016/j.apjtb.2016.09.002
  22. Newton, P. N., Green, M. D., & Fernández, F. M. (2010). Impact of poor-quality medicines in the ‘developing’ world. Trends in Pharmacological Sciences, 31(3), 99– 101. https://doi.org/10.1016/j.tips.2009.11.005
  23. Ngamkhae, N., Chulikhit, Y., Monthakantirat, O., Maneenet, J., Khamphukdee, C., Boonyarat, C., & Daodee, S. (2022). Development and Validation of a High-performance Liquid Chromatography Method for Simultaneous Determination of Five Active Compounds in Kleeb Bua Daeng Formula. Research Journal of Pharmacy and Technology, 3618–3626. https://doi.org/10.52711/0974-360X.2022.00606
  24. Nikolin, B., Imamović, B., Medanhodžić-Vuk, S., & Sober, M. (2004). High performance liquid chromatography in pharmaceutical analyses. Bosnian Journal of Basic Medical Sciences, 4(2), 5–9. https://doi.org/10.17305/bjbms.2004.3405
  25. Ovuru, K. F., Izah, S. C., Yasmin, H., Enerijiofi, K. E., Das, M., & Ogwu, M. C. (2023). Microbial Contaminants of Herbal Remedies: Health Risks and Sustainable Quality Control Strategies (pp. 1–30). https://doi.org/10.1007/978-3-031-21973-3_9-1
  26. Pal, P., Sambhakar, S., Dave, V., Paliwal, S. K., Paliwal, S., Sharma, M., Kumar, A., & Dhama, N. (2021). A review on emerging smart technological innovations in healthcare sector for increasing patient’s medication adherence. Global Health Journal, 5(4), 183–189. https://doi.org/10.1016/j.glohj.2021.11.006
  27. Parveen, A., Parveen, B., Parveen, R., & Ahmad, S. (2015). Challenges and guidelines for clinical trial of herbal drugs. Journal of Pharmacy And Bioallied Sciences, 7(4), 329. https://doi.org/10.4103/0975-7406.168035
  28. Puspitasari, H. P., Aslani, P., & Krass, I. (2015). The influence of pharmacy and pharmacist characteristics on the secondary prevention of cardiovascular disease. International Journal of Clinical Pharmacy, 37(5), 834–843. https://doi.org/10.1007/s11096-015-0127-y
  29. Riaz, M., Khalid, R., Afzal, M., Anjum, F., Fatima, H., Zia, S., Rasool, G., Egbuna, C., Mtewa, A. G., Uche, C. Z., & Aslam, M. A. (2023). Phytobioactive compounds as therapeutic agents for human diseases: A review. Food Science & Nutrition, 11(6), 2500– 2529. https://doi.org/10.1002/fsn3.3308
  30. Rombolà, L., Scuteri, D., Marilisa, S., Watanabe, C., Morrone, L. A., Bagetta, G., & Corasaniti, M. T. (2020). Pharmacokinetic Interactions between Herbal Medicines and Drugs: Their Mechanisms and Clinical Relevance. Life, 10(7), 106. https://doi.org/10.3390/life10070106
  31. Shraim, A. M., Ahmed, T. A., Rahman, M. M., & Hijji, Y. M. (2021). Determination of total flavonoid content by aluminum chloride assay: A critical evaluation. LWT, 150, 111932. https://doi.org/10.1016/j.lwt.2021.111932
  32. Thakkar, S., Anklam, E., Xu, A., Ulberth, F., Li, J., Li, B., Hugas, M., Sarma, N., Crerar, S., Swift, S., Hakamatsuka, T., Curtui, V., Yan, W., Geng, X., Slikker, W., & Tong, W. (2020). Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regulatory Toxicology and Pharmacology, 114, 104647. https://doi.org/10.1016/j.yrtph.2020.104647
  33. Trienekens, J., & Zuurbier, P. (2008). Quality and safety standards in the food industry, developments and challenges. International Journal of Production Economics, 113(1), 107–122. https://doi.org/10.1016/j.ijpe.2007.02.050
  34. Wainwright, C. L., Teixeira, M. M., Adelson, D. L., Braga, F. C., et al., (2022). Future directions for the discovery of natural product-derived immunomodulating drugs: an IUPHAR positional review. Pharmacological Research, 177, 106076. https://doi.org/10.1016/j.phrs.2022.106076
  35. Wang, H., Chen, Y., Wang, L., Liu, Q., Yang, S., & Wang, C. (2023). Advancing herbal medicine: enhancing product quality and safety through robust quality control practices. Frontiers in Pharmacology, 14. https://doi.org/10.3389/fphar.2023.1265178
  36. Youl, O., Moné-Bassavé, B. R. H., Yougbaré, S., Yaro, B., Traoré, T. K., et al., (2023). Phytochemical Screening, Polyphenol and Flavonoid Contents, and Antioxidant and Antimicrobial Activities of Opilia amentacea Roxb. (Opiliaceae) Extracts. Applied Biosciences, 2(3), 493–512. https://doi.org/10.3390/applbiosci2030031
  37. Yuan, H., Ma, Q., Ye, L., & Piao, G. (2016). The Traditional Medicine and Modern Medicine from Natural Products. Molecules,21(5), 559. https://doi.org/10.3390/molecules21050559
  38. Zhang, J., Wider, B., Shang, H., Li, X., & Ernst, E. (2012). Quality of herbal medicines: Challenges and solutions. Complementary Therapies in Medicine, 20(1–2), 100–106. https://doi.org/10.1016/j.ctim.2011.09.004
  39. Zhang, Y., Yang, Y., Ding, L., Wang, Z., Xiao, Y., & Xiao, W. (2021). Emerging Applications of Metabolomics to Assess the Efficacy of Traditional Chinese Medicines for Treating Type 2 Diabetes Mellitus. Frontiers in Pharmacology, 12. https://doi.org/10.3389/fphar.2021.735410
Read More
Author biographies is not available.
Download
PDF
Statistic
Read Counter : 250 Download : 118