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The X-ray fluorescence (XRF) technique was used to determine bromine (Br) concentration in lamivudine/zidovudine/nevirapine (Zidolam-N®) tablets from fourteen batches drawn from different sources. Results showed that Br concentration in falsified drugs was significantly higher than that in the authentic drugs. It was also found that Br concentration in the paper liner of the bottle caps containing the falsified drugs was elevated when compared to the liner from the container holding the authentic drug. In conclusion, falsified (Zidolam-N®) can be rapidly identified using the handheld, portable XRF instrument.
On 22 September 2011, the World Health Organization (WHO) announced the discovery of falsified Zidolam-N® tablets in Kenya. These were labelled as manufactured and supplied by Hetero, India (batch No. E100766). Later, medicines labelled as Hetero batches A9351, A9366 and E110467 were also confirmed to be falsified. Hetero further declared that batches E100766 and E110467 were never supplied to Kenya and that the quantities declared as batches A9351, A9357 and A9366 exceeded those actually manfactured. Falsified medicines labelled as batches A9366 and E100766 were sent to the Kenya National Drug Quality Control Laboratory and to Hetero for examination.
The test results were not conclusive in tracking the source of the falsification. Given this situation, WHO requested the China National Institutes for Food and Drug Control (NIFDC) to develop a rapid detection method to differentiate the authentic from the falsified medicines. The following is a description of testing methods...