Abstract
BackgroundIndia is an increasingly influential player in the global pharmaceutical market. Key parts of the drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs.Methodology/Principal FindingsRandom samples of antimalarial, antibiotic, and antimycobacterial drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard drugs (30% and 0% respectively), as was product heterogeneity, with some drugs being more or less frequently substandard (12% and 7% respectively).Conclusions/SignificanceIn a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the drug regulatory system in India needs to be improved for domestic consumption, and because India is an increasingly important exporter of drugs for both developed and developing countries. Some poor countries with high burdens of disease have weak drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria drugs from India.
Highlights
India presents definite opportunities and potential perils to global health in its prolific pharmaceutical industry, for India is a leading supplier of high quality generic drugs throughout the world, but it is a leading source of counterfeit drugs [1].Substandard and counterfeit drugs have grave consequences for public health
The Indian government estimates that counterfeit drugs account for 0.34% of the total pharmaceutical market and substandard drugs account for 9.34% [3]
Having recorded solely the better-performing sample in the duplicate pair, which is a generous assumption that may understate the incidence of poor drug quality, 12% (34/281) of tested samples failed thin-layer chromatography (TLC) and/or disintegration tests
Summary
India presents definite opportunities and potential perils to global health in its prolific pharmaceutical industry, for India is a leading supplier of high quality generic drugs throughout the world, but it is a leading source of counterfeit drugs [1].Substandard and counterfeit drugs have grave consequences for public health. The Indian government estimates that counterfeit drugs account for 0.34% of the total pharmaceutical market and substandard drugs account for 9.34% [3]. These data are based on samples tested by the state authorities between 1995 and 2003; the extent of substandard drugs varied from 8.19 to 10.64 percent and counterfeit drugs varied between 0.24 and 0.47 percent [3]. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/ extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs
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