Analysis of Policy Impact on Quality of Drugs on Market: the Case of Dissolution of Norfloxacin Tablets

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Published: Feb 1, 2019
Keywords:
national drug policy drug quality drug dissolution norfloxacin

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กนกวรรณ มุจรินทร์
Health Consumer Protection Division, the 10th Regional M Cedical Science Center at Ubonratchathani
ภิรากรณ์ ศรีมงคล
1Health Consumer Protection Division, the 10th Regional M Cedical Science Center at Ubonratchathani
นุศราพร เกษสมบูรณ์
Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University
วรสุดา ยูงทอง
Food and Drug Administration, Ministry of Health

Abstract

Objective: To analyze policy impact on the quality of drugs on the market using dissolution of norfloxacin tablets as a case study. Method: The study was documentary research collecting and reviewing the documents related to the tests on dissolution of norfloxacin tablets. Results of the tests were then linked to policy change by Food and Drug Administration (FDA) in 2008 and 2010. Results: The inspection of dissolution of norfloxacin tablets by the Bureau of Drug and Narcotics in the fiscal year of 2005 revealed that 10 out of 35 of registered products in the sampled (28.57%) failed the standard. Ministry of Public Health (MOPH) by FDA issued policy in the form of 2 orders i.e., the order of MOPH No. 390/2551 on revising the requirement for registered drugs by specifying standard and testing methods for dissolution and the order of MOPH No. 213/2553 on revising the requirement for registered modern drugs listed in the drug compendiums announced by the Minister. In the fiscal year of 2012, the inspection of 64 registered norfloxacin tablets found 14 (21.87%) failed dissolution standard. In the fiscal year of 2015, the inspection of 24 registered norfloxacin tablets by the 10th Medical Sciences Center at Ubonratchathani found 1 (4.17%) failed dissolution standard. It was apparent that percentage of filed products on dissolution test declined after the issuances of those orders in 2008 and 2010. When the results on dissolution test were classified according to registration year of the products, it was found that 24 out of 116 products registered before 2008 (20.69%) failed the standard on dissolution. Analysis of three products registered during 2008-2010 found no products failed the standard on dissolution. One out of four sampled products registered after the issuance of the order in 2010 failed dissolution standard. Conclusion: After the issuances of 2 orders, the failure to meet dissolution standard of norfloxacin tablets declined. However, the study had a small number of samples of drugs registered after the issuances of 2 orders in 2008 and 2010. As a result, a definite conclusion of the impact of policy change on the quality of drugs registered at the different time periods was inconclusive. Further study needs a larger sample size and covers more drugs.

Article Details

Issue
Vol. 8 No. 2 (2016): Jul-Dec
Section
Research Articles

        ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์  บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ 

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