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The drugs procured in this study were readily available over-the-counter without a prescription in Delhi and Chennai pharmacies, including all anti-infectives shown in Table 1. Samples from treatment packs collected from Delhi pharmacies were tested in duplicate in July , comprising 50 ciprofloxacin, 56 chloroquine, 61 erythromycin, 48 isoniazid and 66 rifampicin.

The Contrasting Medicines Regulatory Environments of China and the Western World

The breakdown of failures is as follows: 0. Samples from treatment packs collected from Chennai pharmacies were tested in duplicate in March , comprising 53 ciprofloxacin, 63 chloroquine, 56 erythromycin, 36 isoniazid and 52 rifampicin.

Supplementary Information

In total, samples were collected from pharmacies in Delhi and Chennai, with 8. The authors did not conduct forensic analysis of the drugs to determine whether they were substandard or counterfeit, as results of previous attempts to collect valid samples and batch information from companies for comparative examination were only partly successful.

All four U. Of the 26 pharmacies sampled in Delhi, five pharmacies had no failures, while seven had from 20 to 30 percent failures See Figure 1 ; these seven pharmacies also supplied 10 of the 11 samples found to contain zero active ingredients. Further analysis of the behavior of pharmacists, notably their drug procurement practices, is also warranted, given the variation in drug quality found from different pharmacies around Delhi and Chennai. According to the World Malaria Report , there were an estimated Chloroquine is still the main treatment for uncomplicated malaria in India.

In , there were more than 1. Isoniazid and rifampicin are considered powerful first line drugs for treatment of TB. The failures could be the result of deliberate counterfeiting, or substandard production, transport or storage. The authors discussed these results with several local counterfeit drug investigators. The conclusions of these discussions were as follows: The wide variation in failure rates among pharmacies See Figure 1 suggests that most pharmacists are buying good quality drugs and storing them properly.

Drug Regulation

However, some pharmacists are either buying, wittingly or unwittingly, substandard drugs, expired drugs that have had their packaging possibly re-stamped with new expiry dates, or are incapable or unwilling to store drugs correctly. This variation calls for a system of enforcement to maintain a certain minimum quality criteria.

Given the heavy burden of TB and malaria in the country, it is pertinent that high quality drugs be made available to residents.