Regulatory Compliance of Small-Scale Pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia
Abstract
Background: there is growing concern that medicines supplied to most of the developing countries are of substandard quality. Along with the establishment of strong regulatory systems for ensuring compliance and regulatory law enforcement, manufacturing facilities need to work to implement dependable systems at each stage of the production process to ensure the safety, efficacy, and quality of their products. Objective: the aim of this study was to assess the level of compliance with regulatory requirements by small-scale pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia.
Material & Method: A cross-sectional observational study was conducted using a structured questionnaire and checklist to assess the level of compliance of small-scale local pharmaceutical manufacturing facilities to regulatory requirements and also to identify the challenges faced by the manufacturing facilities.
Result: This study indicated that the overall implementation status of regulatory requirements in the local small-scale pharmaceutical manufacturing companies is far below the minimum standard set by WHO and the national regulatory authority. Basic on specific regulatory requirement elements compliance: requirements related to QA were 26.9, requirements related to personnel qualification were 38.1, requirements related to Quality control were 25.9, and requirements related to sanitation and hygiene were 15.3. Of the total regulatory requirements, only 26.1% were found to be implemented. Major challenges faced by the local small-scale pharmaceutical manufacturing industry for the implementation of regulatory requirements were: human resource capacity constraints, limited investment, limited support from Governments and other stakeholders, and poor infrastructure.
Conclusion: The study demonstrated that level of regulatory requirements implementation in the local small-scale pharmaceutical manufacturers is far below the minimum standard set by the national regulatory authority. Important gaps were reported particularly in materials management, production operations, quality control, and sanitation and hygiene.
Downloads
References
2. SESRIC. Pharmaceutical Industry in OIC Member Countries: Production, Consumption, and Trade, Statistical Economic and Social Research and Training Centre for Islamic Countries (SESRIC), Organization of Islamic Cooperation: Kudüs Caddesi No 9. 06450 Çankaya, Ankara, Turkey [Internet]. 2011 [cited 2022 Feb 22]. Available from:
Available from:
https://www.sesric.org/files/article/433.pdf
3. Amara AH, Aljunid SM. Local pharmaceutical production as means to improve access to essential medicines in developing countries. International Journal of Pharmacy and Pharmaceutical Sciences. 2012;4(4):233-40.
4. Hodel R. Emerging Pharmaceutical Infrastructure in Sub-Saharan Africa. In Chemistry as a Second Language: Chemical Education in a Globalized Society. American Chemical Society; 2010.p.159-180
5. Olliaro PL, Vijayan R, Inbasegaran K, et al. Drug studies in developing countries. Bull World Health Organ. 2001; 79(9):894.
6. Masupye EM, Suleman F, Govender T. Investigating extemporaneous compounding practices in the Polokwane tertiary hospital pharmacies in South Africa-a pilot study. African Journal of Pharmacy and Pharmacology. 2015 Dec 29;9(48):1099-105.
7. Mohiuddin AK. Extemporaneous compounding: cautions, controversies, and convenience. Innovative Journal of Medical and Health Science. 2019;9(1):252-64.
8. Union A. Report of the 8th session of the Africa population commission; 15-16 Sept 2011.
9. EFMHACA. Small scale medicine establishment directive, Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA), Addis Ababa; 2014a.
10. Bartsch S. The global fund to fight AIDS, tuberculosis, and malaria. In Global health governance and the fight against HIV/AIDS. London: Palgrave Macmillan; 2007.p. 146-171
11. EFMHACA (2014b). Good Manufacturing Practice Guideline for Pharmaceutical Products: Main Principles, Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA), Addis Ababa; 2014b
12. Harmonization R. Prequalification of Medicines Programme. WHO Drug Information. 2010;24(1).
13. UNDP. How local production of pharmaceuticals can be promoted in Africa: the case of the United Republic of Tanzania. United Nations Development Programme [Internet]. Dar es Salaam: UNDP; 2016 [cited 2022 Apr 22]. Available from:
https://adphealth.org/upload/resource/Tanzania_Local_Production.pdf.
14. Njeri GM. An investigation of factors affecting work life balance in non-governmental organizations (NGOs): A case of Management Sciences for Health (MSH) (Doctoral dissertation) [Internet]. Africa: United States International University; 2014 Aug 30 [cited 2022 Apr 21]. Available from:
http://erepo.usiu.ac.ke/11732/78
15. Iyer PK. Structure and Performance of Small and Medium Scale Pharmaceutical Firms. India, Science and Technology. [Internet]. 2008 Mar 15 [cited 2022 Apr 27]. Available from::
https://ssrn.com/abstract=1752125
16. Conway M, Holt T, Sabow A, Sun IY. Should sub-Saharan Africa make its own drugs; 2020.
17. Narsai K, Williams A, Mantel-Teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries–perceptions and experiences of pharmaceutical companies in South Africa. Southern med review. 2012 Jul;5(1):31.
18. Gebre-Mariam T, Tahir K, Gebre-Amanuel S. Bringing industrial and health policies closer: reviving pharmaceutical production in Ethiopia. Making Medicines in Africa. London: Palgrave Macmillan; 2016.p. 65-84
19. Rasheed H, Hoellein L, Bukhari KS, Holzgrabe U. Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations. Journal of Pharmaceutical Policy and Practice. 2019 Dec;12(1):1-5.
20. Ekeigwe AA. Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation. AAPS Open. 2019 Dec;5(1):1-5.
21. Tauqeer F, Myhr K, Gopinathan U. Institutional barriers and enablers to implementing and complying with internationally accepted quality standards in the local pharmaceutical industry of Pakistan: a qualitative study. Health policy and planning. 2019 Jul 1;34(6):440-9.
22. Kilama WL. The 10/90 gap in sub-Saharan Africa: resolving inequities in health research. Acta tropica. 2009 Nov 1;112:S8-15.
23. Fromhold-Eisebith M, Schartinger D. Universities as agents in regional innovation systems. Evaluating patterns of knowledge-intensive collaboration in Austria. In The emergence of the knowledge economy. Springer, Berlin, Heidelberg; 2002.p. 173-194
24. Rasheed H, Hoellein L, Bukhari KS, Holzgrabe U. Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations, J of Pharm Policy and Pract. 2019; 12 (23):1-15
doi.org/10.1186/s40545-019-0184-z
25. Kruss G. Balancing old and new organisational forms: changing dynamics of government, industry and university interaction in South Africa. Technology Analysis & Strategic Management. 2008 Nov 1;20(6):667-82.
26. Siyanbola WO, Egbetokun AA, Oluseyi I, Olamade OO, Aderemi HO, Sanni M. Indigenous technologies and innovation in Nigeria: opportunities for SMEs. American Journal of Industrial and Business Management. 2012; 2(2).
27. Collier P. Economic causes of civil conflict and their implications for policy. Department of Economics, Oxford University; April 2006.
28. Dube-Mwedzi S, Kniazkov S, Nikiema JB, Kasilo OM, Fortin A, Tumusiime P, Mahlangu GN, Ndomondo-Sigonda M. A rapid assessment of the National Regulatory Systems for medical products in the Southern African Development Community. Journal of Pharmaceutical Policy and Practice. 2020 Dec;13(1):1-0.
29. Ndomondo-Sigonda M, Miot J, Naidoo S, Dodoo A, Kaale E. Medicines regulation in Africa: current state and opportunities. Pharmaceutical medicine. 2017 Dec;31(6):383-97.
30. Harmonization R. Prequalification of Medicines Programme. WHO Drug Information, Geneva. 2010;24(1).
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
