An assessment of the compliance of some essential drugs in Nigeria to pharmacopoeial specifications

  • N A Ochekpe
  • C C Bello
  • N C Ngwuluka
  • M S Abubakar
  • B Mustapha
  • O A Adegoke
Keywords: Counterfeit drugs, Pharmacopoeia standards

Abstract



The counterfeit drugs phenomenon is a global one. Most developing countries however lack adequate scientific data on the incidence. An attempt has been made to establish the level of counterfeit medicines in Nigeria as at 1993. Sampling and assay of drugs were completed by 1993, prior to the establishment of the National Drug Regulatory Agency. A total of 379 samples were analyzed to determine the percentage content of their active ingredients and the results judged against the British Pharmacopoeia 1988 specifications. The analytical tools employed were those of ultraviolet/visible spectrophotometer and liquid chromatography. A total of 265 (69.9%) drug preparations were found to be outside of BP 1988 specifications of their active ingredients. On application of the Null hypothesis statistical tool to further analyze the data, the overall failure came to 41.4%. Further analysis of the data revealed that of the 379 total samples, 103 (27.2%) were imported while 267 (70.4%) were made in Nigeria. The labels on 9 (2.4%) of the samples did not indicate country of manufacture. 184 (69.4%) of the samples that failed to comply with pharmacopoeia standards were made in Nigeria while the remaining 81 (30.6%) were imported. The study showed that the level of counterfeit drugs in Nigeria as at 1993 was as high as 41.4%.

Keywords: Counterfeit drugs, Pharmacopoeia standards

Journal of Pharmacy and Bioresources Vol. 3 (1) 2006: pp. 7-11
Published
2007-08-06
Section
Articles

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eISSN: 0189-8442