A Pilot Study to Assess for Mislabelling of Drug Samples with Regards to Amount of Active Ingredient

Author(s)

Kondel, R., Pandey, A. K., Arora, A., Shafiq, N., Malhotra, S.

Author's Affiliation

Abstract

Substandard drugs are the drug products whose composition and ingredients do not meet the correct scientific specifications and could be dangerous to the patient. The aim of the present pilot study was to explore whether the active ingredient is within predefined limit in different brands of drug samples in North Indian city. We have collected in total 30 samples of three drugs Atorvastatin, Ethionamide and Phenytoin of different brands from different sectors and have done analysis by HPLC.  The result of the study was that out of 30 samples analyzed, two were found to contain amount not equivalent to the claims according to the packing. The reported incidence of spurious drugs may indeed be overinflated and also generic drugs are not substandard. However, larger studies, from more representative samples of the country need to be undertaken to recognize the true extent of this problem.

Keywords

Substandard Drugs, HPLC, Counterfeit Drugs

Cite This Article

Kondel, R., Pandey, A. K., Arora, A., Shafiq, N., & Malhotra, S. (2014). A Pilot Study to Assess for Mislabelling of Drug Samples with Regards to Amount of Active Ingredient. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 449-452.