Evaluation of National Quality Control Capacity for Herbal Medicines in West Africa: the Case of Benin and Burkina Faso.

Daniel Dori; Gabin A Assanhou; Fernand A Gbaguidi; Brigitte Evrard; Joëlle Quetin-Leclercq; Rasmané Semdé

doi:10.5281/hsd.v21i11.2374

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Abstract

Objective: To assess the capacity of quality control of herbal medicines in two countries in West Africa, thus, Benin and Burkina Faso. Methods: This is a cross-sectional descriptive study, through surveys of 33 manufacturing facilities and 5 independent quality control laboratories listed in the two countries. Results: Among the 33 production units surveyed, only six had space or premises dedicated to quality control. Furthermore, 29 out of the 33 manufacturers used geographic, organoleptic and macroscopic criteria to verify the quality of the raw materials when buying or harvesting. For finished products, they checked the organoleptic characteristics themselves. For more complex analysis, such as the search for microbial contaminants or pesticide residues, they most often used public laboratories at the national level, which are better equipped with skilled staff. Conclusion: These results show that a lot of effort needs to be done in this area by these two countries in order to better ensure the quality and safety of locally produced herbal medicines.

Keywords

Herbal medicine traditional medicine raw materials quality control Benin Burkina Faso.

Author Biography

Daniel Dori, Laboratory of Drug Development, Doctoral School of Sciences and Health, Joseph KI-ZERBO University, Burkina Faso;

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Dori, D., Assanhou, G. A., Gbaguidi, F. A., Evrard, B., Quetin-Leclercq, J., & Semdé, R. (2020). Evaluation of National Quality Control Capacity for Herbal Medicines in West Africa: the Case of Benin and Burkina Faso. HEALTH SCIENCES AND DISEASE, 21(11). https://doi.org/10.5281/hsd.v21i11.2374

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References

WHO (World Health Organization). Traditional medicine: Increasing needs and potentials. Geneva, 2002; (2): 1-6. http://apps.who.int/ medicinedocs/fr/d/Js2294f/ (Consulted on 10 September 2019).
WHO (World Health Organization). Traditional medicine. memory aid
WHO n° 939; Geneva, 2003; 13(2):105-6. http://apps.who.int/gb/archive/pdf_files/WHA56/fa5618.pdf. (Consulted on 10 September 2019).
WHO (World Health Organization). WHO Strategy for Traditional Medicine, 2014-2023. Geneva; 2013. p. 72. https://www.who.int/publications/list/traditional_medicine_strategy/fr/ (Consulted on 11 September 2019).
Mosihuzzaman M, Choudhary MI. Protocols on safety, efficacy, standardization, and documentation of herbal medicine (IUPAC Technical Report). Pure and Applied Chemistry. 2008;80(10):2195–2230. doi:10.1351/pac200880102195
Sofowora A. Medicinal Plants and African Traditional Medicine. Paris: Karthala [u.a.]; 1996. 378 p. (ISBN 2-86537-652-4).
WHO | Quality control methods for herbal materials [Internet]. WHO. [cité 11 oct 2019]. http://www.who.int/medicines/publications/qas_ herbalmed/en/
Srivastava S, Misra A. Quality Control of Herbal Drugs: Advancements and Challenges. In: Singh B, Peter KV, éditeurs. New Age Herbals: Resource, Quality and Pharmacognosy [Internet]. Singapore: Springer Singapore; 2018 [cité 11 oct 2019]. p. 189‑209. https://doi.org/10.1007/978-981-10-8291-7_10
Dori D, Ganfon H, Gbaguidi FA, Quetin-Leclercq J, Semdé R, Evrard B. Overview of regulations on medicines derived from traditional Pharmacopoeia in Benin and Burkina Faso. International Journal of Drug Regulatory Affairs. International Journal of Drug Regulatory Affairs. 15 déc 2019;7(4):8‑13. (10.22270/ijdra.v7j4.361)
Eniojukan JF, Ifudu NC. The Effect of Registration and Regulation on the Use of Herbal Medicines in an Urban Local Government Area of Lagos State, Nigeria. Research in Social and Administrative Pharmacy. 1 nov 2012;8(6):24. https://doi.org/10.1016/j.sapharm.2012.08.056
Chan Fung VSW. Integrating traditional Chinese (herbal) medicines into risk based regulation - With focus on non-clinical requirements to demonstrate safety. Journal of Traditional Chinese Medical Sciences [In Press, Corrected Proof] https://doi.org/10.1016/j.jtcms.2020.03.003
Bouzabata A. Herbal Medicines in Algeria: regulation and registration. Phytotherapy. 1 Dec 2017;15(6):401‑408. doi:https://doi.org/10.1007/s10298-016-1089-5
Qu L, Zou W, Wang Y, Wang M. European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States. Phytomedicine. 15 mars 2018;42:219‑25. doi: 10.1016/j.phymed.2018.03.048
Liang Y-Z, Xie P, Chan K. Quality control of herbal medicines. J Chromatogr B Analyt Technol Biomed Life Sci. 5 déc 2004;812(1‑2):53‑70. doi: 10.1016/j.jchromb.2004.08.041.
Júnior JOCS, Costa RMR, Teixeira FM, Barbosa WLR. Processing and Quality Control of Herbal Drugs and Their Derivatives. Quality Control of Herbal Medicines and Related Areas; 2011; 195-222 p. ISBN 978-953-307-682-9; doi: 10.5772/20346
Yongyu Z, Shujun S, Jianye D, Wenyu W, Huijuan C, Jianbing W, Xiaojun G. Quality Control Method for Herbal Medicine - Chemical Fingerprint Analysis. Quality Control of Herbal Medicines and Related Areas; 2011; 172-194 p. ISBN 978-953-307-682-9; DOI: 10.5772/2396216. Hennell JR. Quality control methods for herbal medicine : a multifaceted approach. [Doctor of Philosophy Thesis] 2012, University of Western Sydney; [United States], [119 p.]. Corpus ID: 79728302
Yang W, Zhang Y, Wu W, Huang L, Guo D, Liu C. Approaches to establish Q-markers for the quality standards of traditional Chinese medicines. Acta Pharmaceutica Sinica B. 1 juill 2017;7(4):439‑46. https://doi.org/10.1016/j.apsb.2017.04.012
Dori D, Méda N, Gbaguidi FA, Quetin-Leclercq J, Semdé R. Wholesale Distribution and Delivery of Herbal Medicines through the phamaceutical circuit in Burkina Faso. French Pharmaceutical Annals. March 2020; 78(2):179‑188. https://doi.org/10.1016/j.pharma.2019.12.003
Health Ministry. National Policy for Traditional Medicine in Benin. Benin; 2013. 37 p.
Health Ministry. Pharmaceutical Policy, 2nd ed., 2012, Burkina Faso, [96 p.; consulted on 16/09/2019] http://www.apps.who.int/medicinedocs/fr/m/ abstract/Js23266fr/.
Health Ministry. National Strategy for Traditional Medicine and Pharmacopoeia, 2nd edition. Burkina Faso; 2015. 37 p.
WAEMU. Decision N° 08/2010/CM/UEMOA related to the adoption of the good practice Guide for the manufacturing of pharmaceutical products for human in the WAEMU member states. WAEMU; 2010
Xie P-S, Leung AY. Understanding the traditional aspect of Chinese medicine in order to achieve meaningful quality control of Chinese materia medica. Journal of Chromatography A. 13 march 2009;1216(11):1933‑40. https://doi.org/10.1016/j.chroma.2008.08.045
Liu WJH. Traditional Herbal Medicine Research Methods: Identification, Analysis, Bioassay, and Pharmaceutical and Clinical Studies. John Wiley & Sons; 2011. 510 p. ISBN 978-0-470-922-66-8 (ebk)
Calixto JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Brazilian Journal of Medical and Biological Research. févr 2000;33(2):179‑89. https://doi.org/10.1590/S0100-879X2000000200004
Steinhoff B. Review: Quality of herbal medicinal products: State of the art of purity assessment. Phytomedicine. 1 juill 2019;60:153003. https://doi.org/10.1016/j.phymed.2019.153003
Head Office for Medicine Quality. European Pharmacopoeia (European treaties series, n° 50). 6th ed. Strasbourg : European Council; 2007. 3538 p.
Liang X, Jin Y, Wang Y, Jin G, Fu Q, Xiao Y. Qualitative and quantitative analysis in quality control of traditional Chinese medicines. Journal of Chromatography A. 2009; 1216(11):2033‑2044. https://doi.org/10.1016/j.chroma.2008.07.026

References

WHO (World Health Organization). Traditional medicine: Increasing needs and potentials. Geneva, 2002; (2): 1-6. http://apps.who.int/ medicinedocs/fr/d/Js2294f/ (Consulted on 10 September 2019).

WHO (World Health Organization). Traditional medicine. memory aid

WHO n° 939; Geneva, 2003; 13(2):105-6. http://apps.who.int/gb/archive/pdf_files/WHA56/fa5618.pdf. (Consulted on 10 September 2019).

WHO (World Health Organization). WHO Strategy for Traditional Medicine, 2014-2023. Geneva; 2013. p. 72. https://www.who.int/publications/list/traditional_medicine_strategy/fr/ (Consulted on 11 September 2019).

Mosihuzzaman M, Choudhary MI. Protocols on safety, efficacy, standardization, and documentation of herbal medicine (IUPAC Technical Report). Pure and Applied Chemistry. 2008;80(10):2195–2230. doi:10.1351/pac200880102195

Sofowora A. Medicinal Plants and African Traditional Medicine. Paris: Karthala [u.a.]; 1996. 378 p. (ISBN 2-86537-652-4).

WHO | Quality control methods for herbal materials [Internet]. WHO. [cité 11 oct 2019]. http://www.who.int/medicines/publications/qas_ herbalmed/en/

Srivastava S, Misra A. Quality Control of Herbal Drugs: Advancements and Challenges. In: Singh B, Peter KV, éditeurs. New Age Herbals: Resource, Quality and Pharmacognosy [Internet]. Singapore: Springer Singapore; 2018 [cité 11 oct 2019]. p. 189‑209. https://doi.org/10.1007/978-981-10-8291-7_10

Dori D, Ganfon H, Gbaguidi FA, Quetin-Leclercq J, Semdé R, Evrard B. Overview of regulations on medicines derived from traditional Pharmacopoeia in Benin and Burkina Faso. International Journal of Drug Regulatory Affairs. International Journal of Drug Regulatory Affairs. 15 déc 2019;7(4):8‑13. (10.22270/ijdra.v7j4.361)

Eniojukan JF, Ifudu NC. The Effect of Registration and Regulation on the Use of Herbal Medicines in an Urban Local Government Area of Lagos State, Nigeria. Research in Social and Administrative Pharmacy. 1 nov 2012;8(6):24. https://doi.org/10.1016/j.sapharm.2012.08.056

Chan Fung VSW. Integrating traditional Chinese (herbal) medicines into risk based regulation - With focus on non-clinical requirements to demonstrate safety. Journal of Traditional Chinese Medical Sciences [In Press, Corrected Proof] https://doi.org/10.1016/j.jtcms.2020.03.003

Bouzabata A. Herbal Medicines in Algeria: regulation and registration. Phytotherapy. 1 Dec 2017;15(6):401‑408. doi:https://doi.org/10.1007/s10298-016-1089-5

Qu L, Zou W, Wang Y, Wang M. European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States. Phytomedicine. 15 mars 2018;42:219‑25. doi: 10.1016/j.phymed.2018.03.048

Liang Y-Z, Xie P, Chan K. Quality control of herbal medicines. J Chromatogr B Analyt Technol Biomed Life Sci. 5 déc 2004;812(1‑2):53‑70. doi: 10.1016/j.jchromb.2004.08.041.

Júnior JOCS, Costa RMR, Teixeira FM, Barbosa WLR. Processing and Quality Control of Herbal Drugs and Their Derivatives. Quality Control of Herbal Medicines and Related Areas; 2011; 195-222 p. ISBN 978-953-307-682-9; doi: 10.5772/20346

Yongyu Z, Shujun S, Jianye D, Wenyu W, Huijuan C, Jianbing W, Xiaojun G. Quality Control Method for Herbal Medicine - Chemical Fingerprint Analysis. Quality Control of Herbal Medicines and Related Areas; 2011; 172-194 p. ISBN 978-953-307-682-9; DOI: 10.5772/2396216. Hennell JR. Quality control methods for herbal medicine : a multifaceted approach. [Doctor of Philosophy Thesis] 2012, University of Western Sydney; [United States], [119 p.]. Corpus ID: 79728302

Yang W, Zhang Y, Wu W, Huang L, Guo D, Liu C. Approaches to establish Q-markers for the quality standards of traditional Chinese medicines. Acta Pharmaceutica Sinica B. 1 juill 2017;7(4):439‑46. https://doi.org/10.1016/j.apsb.2017.04.012

Dori D, Méda N, Gbaguidi FA, Quetin-Leclercq J, Semdé R. Wholesale Distribution and Delivery of Herbal Medicines through the phamaceutical circuit in Burkina Faso. French Pharmaceutical Annals. March 2020; 78(2):179‑188. https://doi.org/10.1016/j.pharma.2019.12.003

Health Ministry. National Policy for Traditional Medicine in Benin. Benin; 2013. 37 p.

Health Ministry. Pharmaceutical Policy, 2nd ed., 2012, Burkina Faso, [96 p.; consulted on 16/09/2019] http://www.apps.who.int/medicinedocs/fr/m/ abstract/Js23266fr/.

Health Ministry. National Strategy for Traditional Medicine and Pharmacopoeia, 2nd edition. Burkina Faso; 2015. 37 p.

WAEMU. Decision N° 08/2010/CM/UEMOA related to the adoption of the good practice Guide for the manufacturing of pharmaceutical products for human in the WAEMU member states. WAEMU; 2010

Xie P-S, Leung AY. Understanding the traditional aspect of Chinese medicine in order to achieve meaningful quality control of Chinese materia medica. Journal of Chromatography A. 13 march 2009;1216(11):1933‑40. https://doi.org/10.1016/j.chroma.2008.08.045

Liu WJH. Traditional Herbal Medicine Research Methods: Identification, Analysis, Bioassay, and Pharmaceutical and Clinical Studies. John Wiley & Sons; 2011. 510 p. ISBN 978-0-470-922-66-8 (ebk)

Calixto JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Brazilian Journal of Medical and Biological Research. févr 2000;33(2):179‑89. https://doi.org/10.1590/S0100-879X2000000200004

Steinhoff B. Review: Quality of herbal medicinal products: State of the art of purity assessment. Phytomedicine. 1 juill 2019;60:153003. https://doi.org/10.1016/j.phymed.2019.153003

Head Office for Medicine Quality. European Pharmacopoeia (European treaties series, n° 50). 6th ed. Strasbourg : European Council; 2007. 3538 p.

Liang X, Jin Y, Wang Y, Jin G, Fu Q, Xiao Y. Qualitative and quantitative analysis in quality control of traditional Chinese medicines. Journal of Chromatography A. 2009; 1216(11):2033‑2044. https://doi.org/10.1016/j.chroma.2008.07.026

Evaluation of National Quality Control Capacity for Herbal Medicines in West Africa: the Case of Benin and Burkina Faso.

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Daniel Dori, Laboratory of Drug Development, Doctoral School of Sciences and Health, Joseph KI-ZERBO University, Burkina Faso;

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