Antimalarial drugs quality monitoring in some provinces of Viet Nam

Thi Minh Thu Nguyen, Thanh Duong Tran

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Abstract

This study was conducted between January and August, 2016 in some malarial prevalence areas of Vietnam including Dak Nong and Gia Lai provinces. Total of 114 anti-malarial medicine samples (of which 55 available antimalarials and 59 selected antibiotics for malaria treatment) were collected from public and private health facilities.


All of the collected samples were screen analized by GPHF-minilab kits at National Institute of Malariology, Parasitology and Entomology (NIMPE) according to GPHF monographs for specifications of visual and physical inspections, disintergration tests and thin layer chromatography assays. None of them was suspicious as substandard quality drugs.


Fifteen randomly chosen samples (13.16% of total samples) were sent to National Institute of Drug Quality Control (NIDQC) for comfirmatory tests according to United States Pharmacopoeia or Vietnamese Pharmacopoeia criteria. The results showed that: three of them (03/114, 2.63%) were found as substandard drugs. All three artesunate 50 mg tablet samples (had the same lot 012013, expiry date in March, 2016, registration number VD-13186-10, collected from private pharmacies in Dak Nong and Gia Lai) did not pass purity tests.


All three substandard drug samples were antimalarials with proportion of 2.63% of total samples and 5.45% of altimalarials.

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