Study of drug quality in the Indian market

June 26, 2009

India is an increasingly influential player in the global pharmaceutical market. A pilot study, conducted in two major cities in India, Delhi and Chennai, explored the proliferation of substandard and counterfeit drugs in the market and discussed how the Indian state and federal governments could improve drug regulation and regulatory enforcement to combat this.

India is an increasingly influential player in the global pharmaceutical market. A pilot study, conducted in two major cities in India, Delhi and Chennai, explored the proliferation of substandard and counterfeit drugs in the market and discussed how the Indian state and federal governments could improve drug regulation and regulatory enforcement to combat this.1

Random samples of antimalarial, antibiotic and antimycobacterial drugs were collected from pharmacies and analysed with semi-quantitative thin-layer chromatography and disintegration testing 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.

According to the study the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, it also states that 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 that thrive in an inadequately regulated environment. It is recommended 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.

1. R. Bate et al., PLoS ONE, 4(6) (2009).