ASSESSMENT OF THE SUBSTANDARD DRUGS IN DEVELOPING COUNTRIES: THE IMPACT OF THE PHARMACEUTICAL REGULATIONS ON THE QUALITY OF MEDICINES ON THE SUDANESE MARKET IMPORTERS’ PERSPECTIVE
Abstract
The strategy of price liberalization and privatization had been implemented in Sudan over the last decade and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatization policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of the Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market are generally of good quality. The design of the research itself may be considered inadequate with regard to the selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics, and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up including the Act itself needs to be revised.
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References
2. Alubo, S.O. (1994). Death for sale: A study of drug poisoning and deaths in Nigeria. Social Science & Medicine 38(1): 97 – 103.
3. Andalo, D. (2004). Counterfeit drugs set alarm bells ringing. Pharmaceutical Journal 273- 341.
4. Bryman, A. (2004). Social Research Method. (2nd Edition). Oxford University Press.
5. Elfadil, A.A. (2005). Quality assurance and quality control in the CMSPO.
6. Erhun, W.O., Babalola, O.O., and Erhun, M.O. (2001). Drug regulation and control in Nigeria: The counterfeit drugs. Journal of Health and Population in Developing Countries 4(2): 23– 34.
7. Gamal, K. M., Omer, A. M. (2006). A prescription for improvement: A short survey to identify reasons behind public sector pharmacists’ migration. World Health and Population 2006: 1-24
8. Helling-Borda, M. (1995). The role and experience of the World Health Organisation in assisting countries to develop and implement national drug policies. Australian Prescriber 20 (Supp. 1): 34–38.
9. Jallow, M. (1991). Evaluation of national drug policy in the Gambia, with special emphasis on the essential drug programme. University of Oslo: Norway.
10. Lexchin, J. (1990). Drugmakers and drug regulators: Too close for comfort. A study of the Canadian situation. Social Science and Medicine 31(11): 1257 – 1263.
11. Lofgren, H., and Boer, R. (2004). Pharmaceuticals in Australia: developments in regulation and governance. Social Science and Medicine 58: 2397 – 2407.
12. Ministry of Health (MOH). (2003). 25 years Pharmacy Strategy (2002-2027). Khartoum: Sudan. Unpublished Report.
13. National Drug Policy (NDP). (1997). Ministry of Health (MOH): Sudan.
14. Osibo, O.O. (1998). Faking and counterfeiting of drugs. West African Journal of Pharmacy 12(1): 53 – 57.
15. Ratanwijitrasin, S., Soumerai, S.B., and Weerasuriya, K. (2001). Do national medicinal drug policies and essential drug programs improve drug use? A review of experiences in developing countries. Social Science & Medicine 53: 831–844.
16. Rudolf, P. M., and Bernstein, I.B.G. (2004). Counterfeit Drugs. New England Journal of Medicine 350(14): 1384 - 1386.
17. Shakoor, O., Taylor, R.B., and Behrens, R.H. (1997). Assessment of substandard drugs in developing countries. Tropical Medicines and International Health 2(9): 839 – 845.
18. Sibanda, F.K. (2004). Regulatory excess: The role of regulatory impact assessment and the Competition Commission. In: Proceedings of the Pro-Poor Regulation and Competition Conference hosted by the Centre of Regulation and Competition (CRC), University of Manchester, UK, and the School of Public Management & Planning, University of Stellenbosch, Cape Town, 7-9 September 2004.
19. WHO. (1991). Counterfeit drugs: guidelines for the development of measures to combat counterfeit drugs. Geneva: World Health Organisation. WHO/EDM/QSM/1990.1.
20. World Health Organisation / Drug Action Programme (WHO/DAP). (1996). Comparative analysis of international drug policies. Report from the second workshop Geneva, June 1996.
21. WHO. (2009). International drug policies. Geneva: Switzerland.
