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Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia

A Correction to this article was published on 08 June 2022

This article has been updated

Abstract

Background

Medicines of poor quality are currently prevailing problems undermining the quality of health care services in veterinary and human medicine. In this study, physico-chemical quality of veterinary medicines was evaluated.

Methods

A total of 959 veterinary medicines samples were collected during routine regulatory activities, i.e. pre-registration, re-registration, consignment checking and post-marketing surveillance, in Ethiopia. The samples were transported to Animal Products, Veterinary Drug and Feed Quality Assessment Centre (APVD-FQAC), which is the quality control laboratory of the Veterinary Drug and Feed Administration and Control Authority (VDFACA) and stored until analysis. The samples were subjected to visual inspection and chemical analysis following the United States, European or British Pharmacopoeias, or manufacturer’s methods.

Results

The findings revealed that 12 (1.3%) of tested products showed defects in physical characteristics, packaging, or labelling information, while a total of 66 (6.9%) samples of the investigated products failed to comply with the Pharmacopoeias and supplier’s specification limit set for assay. Of these, 60 samples did not comply with the minimum assay specification limit.

Conclusion

Overall, 8.2% of the investigated veterinary medicine samples did not comply with the specification set for the investigated quality attributes and thus were categorized as of poor quality. This indicates the need for continued strengthening of regulatory functions.

Background

The livestock sector is one of the potential areas that play a critical role in ensuring food security and livelihoods [1, 2]. Thus, there is a shift of farming practices, and an increment and intensification of food animal production [3, 4] which in turn could increase zoonotic and trans-boundary animal diseases that may lead to the increased use of veterinary medicines [5,6,7]. The global veterinary medicine market expected to reach $85,059.4 million by 2030 [8]. Though veterinary medicines are one of the critical elements in improving productivity of livestock, informal pharmaceutical supply chains and illegal marketing, poor-quality medicines, medicines misuse and inappropriate use are prevailing factors [9,10,11], that could contribute to treatment failure, antimicrobial resistance development and economic losses [12,13,14,15].

In many low- and middle-income countries (LMICs), the National Regulatory Authorities (NRAs) are still under resourced [16]. Even if the World Health Organization (WHO) Global Benchmarking of Regulatory Systems can now be a game changer to guide regulatory strengthening [17], substantial investments will be needed to reach an adequate regulatory maturity [18] everywhere. The weak regulatory systems, scarce resources, poor infrastructure and lack of trained personnel [16, 19,20,21], contribute to the relatively huge burden of the aforementioned problems in LMICs [20, 22, 23]. Thus, assessing the quality of medicines according to stringent criteria and monitoring their rational use, is crucial, including in the veterinary sector [24] to explore multiplicity and prevalence of the problem and ensure quality health care services.

In Ethiopia, owning to the prevalence of infectious animal diseases [16, 18,19,20], veterinary medicines such as antibiotics, anthelmintics, antiprotozoals and acaricides are widely used [21, 22]. However, there is scarce information regarding the quality of veterinary medicines circulating in the market [23, 24]. Therefore, the present study was conducted. It was nested in regulatory inspections routinely conducted by the Ethiopian Veterinary Drug and Food Administration and Control Authority (VDFACA). The Authority is a public organization established in 2011 and it is responsible for the registration, licensing, inspection, quality verification and regulation of Veterinary Medicinal Products (VMPs), commercial animal feed and feed supplements. Hence, no VMPs, feed and feed supplements may be produced locally or imported from abroad and put in use, unless it is registered by the Authority after being tested for its quality and safety (proclamation no. 728/2011) [25]. The VDFACA collaborates with the Animal Product, Veterinary Drug and Feed Quality Assessment Center (APVD-FQAC), which is a quality control laboratory established as entity of VDFACA in June 2014. The APVD-FQAC provides laboratory testing services to the public, to verify the quality and safety standards of primary livestock products, VMPs and commercial animal feedstuffs. In this study, the physico-chemical quality of veterinary medicine samples collected by VDFACA during pre-registration, re-registration, consignment check and post-marketing surveillance was assessed at APVD-FQAC.

Methods

Study area and design

The study was conducted in Ethiopia which is located in the Horn of Africa. Cross-sectional study was conducted between November 2016 to June 2021 for the purpose of regulatory activities, i.e. pre-registration, re-registration, consignment check and post-marketing surveillance of veterinary medicines.

Sample collection and sampling techniques

The sample collection of veterinary medicines is routinely conducted by the VDFACA for the purpose of regulatory inspection, i.e. pre-registration, re-registration, consignment check and post-marketing surveillance. We included in the present study, all samples encompassing acaricides, anthelmintics, antibacterials, antiprotozoals and miscellaneous, obtained between 16 November 2016 and 22 June 2021. Samples were provided by the supplier to the VDFACA quality control laboratory when submitting the request for registration or re-registration; or collected during regulatory inspection conducted at import entry check points for consignment or throughout the country for post-marketing surveillance, across different levels of veterinary supply chain. The samples were immediately labelled with a study code and accompanying information of samples was recorded (i.e. sample collection and submission dates, sampling purpose, international nonproprietary name trade name, dosage form, strength, manufacturing and expiry dates, batch number, active pharmaceutical ingredients, storage temperature, stated country of origin, sample collection place, method of analysis). Overall, 959 samples were purposively collected as part of ongoing regulatory inspections.

Samples were properly transported to VDFACA quality control laboratory, Addis Ababa, Ethiopia, for testing, and stored until analysis, according to product manufacturers storage recommendations and in line with WHO Good storage and distribution practices for medical products [26].

Chemicals, reagents, solvents, and certified reference materials (CRMs)

Methanol, acetonitrile, hydrochloric acid 37% and sulfuric acid 98%, ammonium dihydrogen phosphate, sodium hydroxide, sodium dodecyl sulphate, and sodium dihydrogen orthophosphate were used. All chemicals, reagents and solvents used were analytical grade and met the required purity standards set for specific test and analyses.

Physico-chemical quality test

All veterinary medicine samples collected for regulatory purpose between 16 November 2016 and 22 June 2021 were subjected to visual inspection by VDFACA experts and to chemical analysis for identity and assay. High-performance liquid chromatography (HPLC-Shimadzu-CTO-20AC) with UV–Vis detector, gas chromatography (GC-Agilent-7890A) with flame ionization detector (FID), UV–Vis spectrophotometer (Jenway-6850) and automatic titrator (Hanon-T860) analytical instruments were used for chemical analyses. The visual inspection encompassing physical characteristics, packaging and labelling information was conducted using the checklist described elsewhere [27] presented in the additional file (see Additional file 1). The chemical analyses were conducted according to the standard methods described in the US, European or British Pharmacopoeias [28] and/or supplied by the manufacturer, in case of in-house specifications.

Results

Physico-chemical quality test

The physico-chemical quality of veterinary medicine samples (n = 959) encompassing acaricides (n = 19), anthelmintics (n = 456), antibacterials (n = 314), antiprotozoals (n = 106), miscellaneous, i.e. vitamins, synchromate hormones, disinfectants, and anaesthesia (n = 26) collected during pre-registration, re-registration, consignment check or post-marketing surveillance was evaluated. The descriptions of defects on samples and supplied documents observed during visual inspection are depicted in Table 1. Overall, the results of visual inspection revealed that 12 (1.3%) samples had defects in physical characteristics (Table 2). Out of the total 959 samples examined, 6 (0.6%) of anthelmintic samples submitted for pre-registration were rejected on visual inspection without undertaking any chemical analysis, due to major physical quality defect findings at the time of sample reception.

Table 1 Descriptions of defects on the samples and supplied documents observed during visual inspections
Table 2 Visual inspection vs. chemical analyses non-compliance summary results (n = 959)

The results of identity test indicated that all samples contain the intended active pharmaceutical ingredient (API) that matches with the product’s label claim. However, out of 953 samples investigated for the purpose of regulatory inspection, 66 (6.9%) samples failed to comply with the pharmacopoeia’s and/or suppliers specifications limits regarding the required amount of API contents. Furthermore, 60 samples out of 953 (6.3%) passed the visual inspections, but later failed to comply with assay result specifications.

The assay results of 66 samples deviated from assay specification limit (%label claim (lc.): minimum and maximum) set for each investigated product. The out of specification (OOS) samples assay results are presented in Table 3.

Table 3 The OOS samples assay results (%lc.) showing deviation from minimum and maximum assay specification limit

The detailed information on test results (identity and assay) of each sample is presented in the additional file (see Additional file 2).

The results of the quality of medicines categorized based on the source of samples; therapeutic category, level of supply chain and stated production origins are presented in Table 4.

Table 4 The results of physico-chemical quality of veterinary medicines samples (n = 953)

Discussion

Quality assured medicines are critical in preventing and mitigating diseases and preventing the emergency of resistance, as well as reducing risks attributed to use of poor-quality medicines. In recent years, there has been growing awareness of the treats to individual and public health represented by poor-quality medicines for human use, but the field of veterinary medicines remains relatively neglected. In this study, nested in routine regulatory activities in Ethiopia, the physico-chemical quality of veterinary medicines was assessed for the purpose of regulatory inspection. The results of this study revealed that 1.3% (12/959) failed the visual inspections, and 6.9% (66/953) of samples failed to comply with the specification limit set for the tested quality attributes. Interestingly, 60 samples out of 953 (6.3%) did not reveal any visible defect when visually inspected, but failed to comply with assay result specifications. This indicates a relatively low predictive value of the visual inspection for this specific determinant of pharmaceutical quality. Though there is scarce information regarding quality of veterinary medicine circulating in Ethiopia, 28% samples of trypanocidal medicines and 50% samples of albendazole brands investigated in previous studies failed to comply with the quality requirements set for the tested quality parameters [29,  30].

The observed poor quality of medicines may reflect failure of pharmaceutical manufacturers to comply with the Good Manufacturing Practice (GMP) [31], or failure to implement adequate storage and distribution practices along the supply chain [26]. In fact, it is difficult to distinguish quality problems caused by poor practices at manufacturing sites vs. those caused by poor practice along the distribution chains. In our study, however, a higher prevalence of out-of-specifications was found during post-market surveillance (10.8%), and at retailers (11.2%) and wholesalers (20%), suggesting the additional impact of poor storage and distribution practices. The lack of stringent medicines regulatory systems, clearly limits countries’ capacity to detect, prevent and respond to poor-quality medicines [32]. This suggests the need for stronger control and monitoring of quality of veterinary pharmaceuticals during production, procurement, distribution/supply, storage, and surveillance. It is hoped that the forthcoming African Medicine Agency (AMA) [33] will represent a game changer for strengthening regulatory oversight across the continent, including for veterinary medicines.

It is well known that administering poor-quality medicines (i.e. substandard and falsified) [34] leads to poor or reduced treatment outcomes, toxicity and antimicrobial resistance [35,36,37], in addition to causing an unnecessary economic burden on the health system [38]. The poor quality of about 8.2% of the medicines investigated in this study implies a potential negative consequence also in the animal disease prevention and control efforts, as well as economy of the country. In areas where there is application of inappropriate dosage and incorrect duration of veterinary medicines due to lack of knowledge and involvement of non-professionals [39,40,41,42], the impact might be even higher. In Ethiopia, weak medicine regulation and involvement of non-professional actors in the veterinary sector [43, 44] could contribute to the infiltration of poor-quality medicines into medicines supply chain. Furthermore, all medicines analysed in this study were subjected to regulatory oversight; it may be hypothesized that the prevalence of out-of-specifications would be higher for medicines circulating in the informal market. Given that fact that veterinary medicines such as tetracyclines, albendazole and diminazene diaceturate are essential medicines widely used in veterinary sectors in Ethiopia, the quality failure observed for these medicines could jeopardize the existing efforts in veterinary services [44, 45].

Our study has a few limitations: for instance, we could not make distinctions between products originally of poor quality and those that degraded along the supply chain; we only sampled product available in the formal sector; and we did not carry out all the Pharmacopoeial tests, e.g. we did not conduct dissolution and impurity tests. Also, not all the regions in Ethiopia were equally represented. Thus, the findings of this report are likely to be the iceberg of the real situation on the ground and points to the need for further actions in conducting wide-ranging studies. Such studies should either be nested in regulatory activities, or conducted in partnership with the regulatory authorities, so as to provide them with immediate guidance on prevalence and distribution of poor medicines, for corrective measures.

Conclusions

The results of the present study indicated that 8.2% the investigated samples of veterinary medicines failed to comply with one or more of the assessed quality standards. Therefore, continued strengthening of the inspection of veterinary medicines and drug regulatory functions is highly recommended.

Availability of data and materials

All the data and materials will be made available on request to the corresponding author.

Change history

Abbreviations

AMA:

African Medicine Agency

APVD-FQAC:

Animal Products, Veterinary Drug and Feed Quality Assessment Centre

BP:

British Pharmacopoeia

CoA:

Certificate of Analysis

CRMs:

Certified Reference Materials

EDQM:

European Directorate for the Quality of Medicine

EP:

European Pharmacopoeia

FAO:

Food and Agriculture Organization of the Untied Nation

GC:

Gas chromatography

GMP:

Good Manufacturing Practice

HPLC:

High-performance liquid chromatography

JuLaDQ:

Jimma University Laboratory of Drug Quality

LMICs:

Low- and middle-income countries

NRAs:

National Regulatory Authorities

USP:

US Pharmacopoeia

References

  1. Gassner A, Harris D, Mausch K, et al. Poverty eradication and food security through agriculture in Africa: rethinking objectives and entry points. Outlook Agric. 2019;48:309–15.

    CAS  Article  Google Scholar 

  2. Paul BK, Groot JCJ, Maass BL, et al. Improved feeding and forages at a crossroads: farming systems approaches for sustainable livestock development in East Africa. Outlook Agric. 2020;49:13–20.

    Article  Google Scholar 

  3. Price LB, Koch BJ, Hungate BA. Ominous projections for global antibiotic use in food-animal production. Proc Natl Acad Sci U S A. 2015;112:5554–5.

    CAS  Article  Google Scholar 

  4. Van BTP, Brower C, Gilbert M, et al. Global trends in antimicrobial use in food animals. Proc Natl Acad Sci. 2015;112:5649–54.

    Article  Google Scholar 

  5. Vougat Ngom RRB, Tomdieu T, Ziébé R, et al. Quality of veterinary pharmaceuticals and their use by pastoralists in the Far North Region of Cameroon. Pastoralism. 2017;7:1–14.

    Article  Google Scholar 

  6. Falowo AB, Akimoladun OF. Veterinary drug residues in meat and meat products: occurrence, detection and implications. Vet Med Pharm. 2019. https://doi.org/10.5772/INTECHOPEN.83616.

    Article  Google Scholar 

  7. Tufa TB, Gurmu F, Beyi AF, et al. Veterinary medicinal product usage among food animal producers and its health implications in Central Ethiopia. BMC Vet Res. 2018;14:1–7.

    Article  Google Scholar 

  8. GAMMOS. Global Animal Medicine Market Opportunities and Strategies Report 2020–2030—ResearchAndMarkets.com | Business Wire, https://www.businesswire.com/news/home/20210111005495/en/Global-Animal-Medicine-Market-Opportunities-and-Strategies-Report-2020-2030---ResearchAndMarkets.com. 2021. Accessed 1 Oct 2021.

  9. Quynh HL, Bich TNT, Hoang LT, et al. Quality testing of veterinary antimicrobial products used for livestock in Vietnam, 2018–2019. PLoS ONE. 2021;16: e0247337.

    Article  Google Scholar 

  10. Beyene T, Tesega B. Rational veterinary drug use: its significance in public health. J Vet Med Anim Health. 2014;6:302–8.

    Google Scholar 

  11. Tekle T, Terefe G, Cherenet T, et al. Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia. BMC Vet Res. 2018;14:1–8.

    Article  Google Scholar 

  12. Kolozsvári LR, Kónya J, Paget J, et al. Patient-related factors, antibiotic prescribing and antimicrobial resistance of the commensal Staphylococcus aureus and Streptococcus pneumoniae in a healthy population—Hungarian results of the APRES study. BMC Infect Dis. 2019. https://doi.org/10.1186/s12879-019-3889-3.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Castro-Sánchez E, Moore LSP, Husson F, et al. What are the factors driving antimicrobial resistance? Perspectives from a public event in London, England. BMC Infect Dis. 2016. https://doi.org/10.1186/s12879-016-1810-x.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Newton PN, Green MD, Fernández FM. Impact of poor-quality medicines in the ‘developing’ world. Trends Pharmacol Sci. 2010;31:99.

    CAS  Article  Google Scholar 

  15. Gml N, Jg B, Tk M, et al. Falsified and substandard drugs: stopping the pandemic. Am J Trop Med Hyg. 2019;100:1058–65.

    Article  Google Scholar 

  16. Ndomondo-Sigonda M, Miot J, Naidoo S, et al. Medicines regulation in Africa: current state and opportunities. Pharm Med. 2017;31:383–97.

    Article  Google Scholar 

  17. Guzman J, O’Connell E, Kikule K, et al. The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity. BMJ Glob Health. 2020;5: e003181.

    Article  Google Scholar 

  18. Roth L, Bempong D, Babigumira JB, et al. Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems. Glob Health. 2018;14:1–12.

    Article  Google Scholar 

  19. Ndomondo-Sigonda M, Ambali A. The African medicines regulatory harmonization initiative: rationale and benefits. Clin Pharmacol Ther. 2011;89:176–8.

    CAS  Article  Google Scholar 

  20. Aminu N, Sha’aban A, Abubakar A, et al. Unveiling the peril of substandard and falsified medicines to public health and safety in Africa: need for all-out war to end the menace. Med Access @ Point Care. 2017;1:maapoc.0000023. https://doi.org/10.5301/maapoc.0000023.

    Article  Google Scholar 

  21. Ndomondo-Sigonda M, Miot J, Naidoo S, et al. National medicines regulatory authorities financial sustainability in the East African Community. PLoS ONE. 2020;15: e0236332.

    CAS  Article  Google Scholar 

  22. Tchamdja E, Kulo AE, Akoda K, et al. Drug quality analysis through high performance liquid chromatography of isometamidium chloride hydrochloride and diminazene diaceturate purchased from official and unofficial sources in Northern Togo. Prev Vet Med. 2016;126:151–8.

    CAS  Article  Google Scholar 

  23. Nayyar GML, Breman JG, Mackey TK, et al. Falsified and substandard drugs. Stopping the pandemic. Am J Trop Med Hyg 2019;1–8.

  24. Ponte H, Ivo RS, Silva-Lima B, et al. Quality control programmes for veterinary antimicrobial medicines. Regul Toxicol Pharmacol. 2018;99:1–4.

    Article  Google Scholar 

  25. FDRE. Proclamation No. 728–2011 Veterinary Drug and Feed Free pdf download—1327831—DocDatabase.net. 2011. http://www.docdatabase.net/more-proclamation-no-728-2011-veterinary-drug-and-feed--1327831.html. Accessed 13 Oct 2021.

  26. WHO. WHO Good storage and distribution practices for medical products—ECA Academy. 2020. https://www.gmp-compliance.org/guidelines/gmp-guideline/who-good-storage-and-distribution-practices-for-medical-products. Accessed 12 Oct 2021.

  27. Schiavetti B, Wynendaele E, Melotte V, et al. A simplified checklist for the visual inspection of finished pharmaceutical products: A way to empower frontline health workers in the fight against poor-quality medicines. J Pharm Policy Pract. 2020. https://doi.org/10.1186/S40545-020-00211-9.

    Article  PubMed  PubMed Central  Google Scholar 

  28. USP. United state pharmacopeia (USP): National formulary USP official Monograph, USP 35, https://www.drugfuture.com/Pharmacopoeia/usp35/PDF/2082-2083AlbendazoleTablets.pdf. 2015. Accessed 1 Oct 2021.

  29. Tekle T, Terefe G, Cherenet T, et al. Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia. BMC Vet Res. 2018. https://doi.org/10.1186/S12917-017-1327-6.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Seifu A, Kebede E, Bacha B, et al. Quality of albendazole tablets legally circulating in the pharmaceutical market of Addis Ababa, Ethiopia: physicochemical evaluation. BMC Pharmacol Toxicol. 2019. https://doi.org/10.1186/s40360-019-0299-5.

    Article  PubMed  PubMed Central  Google Scholar 

  31. ECA. Frequent GMP Violations in pharmaceutical companies (1): testing and release for distribution—ECA Academy. 2017. https://www.gmp-compliance.org/gmp-news/frequent-gmp-violations-in-pharmaceutical-companies-1-testing-and-release-for-distribution. Accessed 27 Sept 2021.

  32. Mv S. The role of veterinary medicine regulatory agencies. Rev Sci Tech. 2013;32:393–408.

    Article  Google Scholar 

  33. Ncube BM, Dube A, Ward K. Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. J Pharm Policy Pract. 2021;14:1–12.

    Article  Google Scholar 

  34. Organization WH. WHO global surveillance and monitoring system for substandard and falsified medical products. World Health Organization, 2017.

  35. Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NP, Greenwood BM, Nosten FWN. Impaired clinical response in a patient with uncomplicated falciparum malaria who received poor-quality and underdosed intramuscular artemether. Am J Trop Med Hyg. 2008;78(4). https://www.ajtmh.org/view/journals/tpmd/78/4/article-p552.xml. Accessed 27 Sept 2021.

  36. Hufnagel H. Livestock emergency guidelines and standards the quality of veterinary pharmaceuticals a discussion paper for the Livestock Emergency Guidelines and Standards (LEGS). 2020. https://healthforanimals.org/169-new-repor. Accessed 27 Sept 2021.

  37. Clifford K, Desai D, da Costa CP, et al. Antimicrobial resistance in livestock and poor quality veterinary medicines. Bull World Health Organ. 2018;96:662–4.

    Article  Google Scholar 

  38. Buckley GJ, Gostin LO, Committee on understanding the global public health implications of Substandard F and CMP, et al. The effects of falsified and substandard drugs. 2013. https://www.ncbi.nlm.nih.gov/books/NBK202526/. Accessed 12 Oct 2021.

  39. Beyene Tufa T, Gurmu F, Feyisa Beyi A, et al. Veterinary medicinal product usage among food animal producers and its health implications in Central Ethiopia. BMC Vet Res. 2018. https://doi.org/10.1186/s12917-018-1737-0.

    Article  Google Scholar 

  40. Koji F, Kumbe A, Beyene A. Cross-sectional assesses on irrational use of veterinary drugs in Adami Tulu Jiddo Kombolcha Distrct, East Shoa Zone, Oromia Regional State, Ethiopia. http://www.sciencepublishinggroup.com 2020; 8: 22.

  41. Desta AH. Veterinary drugs handling, management and supply chain assessment in afar pastoral region of North East Ethiopia. http://www.sciencepublishinggroup.com 2015; 3: 142.

  42. D T. Review on rational use of veterinary antimicrobials and anthelmintics. 2018. https://austinpublishinggroup.com/veterinary-science-research/fulltext/avsah-v5-id1044.php. Accessed 1 Oct 2021.

  43. Suleman S, Woliyi A, Woldemichael K, et al. Pharmaceutical regulatory framework in Ethiopia: a critical evaluation of its legal basis and implementation. Ethiop J Health Sci. 2016;26:259.

    Article  Google Scholar 

  44. Kebede H, Melaku A, Kebede E. Constraints in animal health service delivery and sustainable improvement alternatives in North Gondar, Ethiopia. Onderstepoort J Vet Res. 2014. https://doi.org/10.4102/OJVR.V81I1.713.

    Article  PubMed  Google Scholar 

  45. Yokamo S, Mulugeta S, Hayiso H. Assessment of veterinary service delivery in Shebedino district of Sidama Zone, Southern Ethiopia. J Vet Sci Technol; 10.

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Acknowledgements

The authors would like to thank VDFACA staff who contributed to the sample collection and analysis. In addition, we are grateful for the inputs of scholars from Jimma University, Ethiopia, and Food and Agriculture Organization of the Untied Nation, Ethiopia.

Funding

VDFACA and MoA financially supported the regulatory activities.

Author information

Authors and Affiliations

Authors

Contributions

BT and SB conceptualized and designed the study and manuscript review and editing. BB and GU contributed to coordination and analysis of samples. RR and TA contributed to manuscript review and editing. ZA and AZ contributed to data recording and management. TS, AH, DJ, DD and BBL contributed to sample analysis. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Belachew Tefera.

Ethics declarations

Ethics approval and consent to participate

This study was conducted by Animal Products, Veterinary Drug and Feed Quality Assessment Centre in partnership with the Ethiopia Veterinary Drug and Feed Administration and Control Authority. It did not imply collection, analyses or used of any personal data. Commercial information of clients are kept confidential unless reproduction or disclosure is required by law.

Consent for publication

Not applicable.

Competing interests

All authors declare that there is no any competing interest.

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The original online version of this article was revised: Following the publication of the original article, we were notified that the first and last name of the 4th author are swapped. Ravinetto Raffaella should be Raffaella Ravinetto.

Editorial responsibility: Zaheer Babar, University of Huddersfield, UK.

Supplementary Information

Additional file 1:

Checklist.

Additional file 2:

Identity and assay results.

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Tefera, B., Bacha, B., Belew, S. et al. Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia. J of Pharm Policy and Pract 15, 17 (2022). https://doi.org/10.1186/s40545-022-00410-6

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Keywords

  • Ethiopia
  • Medicines
  • Quality
  • Regulatory authority
  • Surveillance
  • Veterinary