Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis

Int J Tuberc Lung Dis. 2013 Mar;17(3):308-11. doi: 10.5588/ijtld.12.0355. Epub 2013 Jan 14.


Setting: Pharmacies in 19 cities in Angola, Brazil, China, Democratic Republic of Congo, Egypt, Ethiopia, Ghana, India (n = 3), Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, United Republic of Tanzania and Zambia.

Objective: To assess the quality of the two main first-line anti-tuberculosis medicines, isoniazid and rifampicin, procured from private-sector pharmacies, to determine if substandard and falsified medicines are available and if they potentially contribute to drug resistance in cities in low- and middle-income countries.

Design: Local nationals procured 713 treatment packs from a selection of pharmacies in 19 cities. These samples were tested for quality using 1) thin-layer chromatography to analyze levels of active pharmaceutical ingredient (API), and 2) disintegration testing.

Results: Of 713 samples tested, 9.1% failed basic quality testing for requisite levels of API or disintegration. The failure rate was 16.6% in Africa, 10.1% in India, and 3.9% in other middle-income countries.

Conclusions: Substandard and falsified drugs are readily available in the private marketplace and probably contribute to anti-tuberculosis drug resistance in low- and middle-income countries. This issue warrants further investigation through large-scale studies of drug quality in all markets.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Africa
  • Antitubercular Agents / analysis*
  • Antitubercular Agents / standards
  • Asia
  • Chemistry, Pharmaceutical
  • Chromatography, Thin Layer
  • Community Pharmacy Services
  • Counterfeit Drugs / analysis*
  • Crime*
  • Developing Countries
  • Drug Resistance, Bacterial
  • Drug Stability
  • Drug Storage
  • Humans
  • Isoniazid / analysis*
  • Isoniazid / standards
  • Private Sector
  • Quality Control
  • Rifampin / analysis*
  • Rifampin / standards
  • Russia
  • Solubility


  • Antitubercular Agents
  • Counterfeit Drugs
  • Isoniazid
  • Rifampin