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Related Experiment Videos

Quality control in generic anthelmintics: is it adequate?

J A van Wyk1, F S Malan, L J van Rensburg

  • 1Division of Helminthology, Onderstepoort Veterinary Institute, South Africa.

Veterinary Parasitology
|December 24, 1997
PubMed
Summary

Some generic rafoxanide anthelmintics for sheep showed substandard efficacy, impacting sheep farming. Batch testing is crucial to ensure product quality and effectiveness against parasites.

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Area of Science:

  • Veterinary Parasitology
  • Pharmaceutical Sciences

Background:

  • Concerns exist regarding the efficacy of generic anthelmintics.
  • Substandard efficacy of imported generic anthelmintics has been previously noted.
  • Sheep farming is significantly impacted by anthelmintic effectiveness.

Purpose of the Study:

  • To evaluate the efficacy of generic rafoxanide products available in South Africa.
  • To identify potential issues with generic anthelmintic quality control.

Main Methods:

  • Testing three commercial generic rafoxanide formulations against susceptible and partially resistant strains of Haemonchus contortus in sheep.
  • Statistical analysis of efficacy data using Mann-Whitney test.

Main Results:

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  • One formulation demonstrated markedly substandard efficacy (66.2%) against a susceptible strain.
  • Efficacy differences were more pronounced against a partially resistant strain, with one product being ineffective (28.7%).
  • Significant variations in efficacy were observed between different products.

    • Conclusions:

    • Inconsistent efficacy of generic rafoxanide is likely due to undisclosed changes in active ingredient sources.
    • Current batch efficacy testing may be inadequate.
    • Regulatory authorities should consider simplified efficacy testing for new active ingredient batches.