LEGAL PROBLEMS ON DRUG QUALITY CONTROL IN THE DRUG LOGISTICS IN THAILAND

Abstract

Assuring the quality of drugs throughout the drug supply chain, from the point of manufacture to the point of delivery to the patients is of extreme importance.   There are many factors affecting the stability of drugs, ranging from the manufacturing process, the environmental conditions, such as,,  temperature, light, and humidity encountered during transportation to distribution, storage and other activities in the logistics process.

            In Thailand, the problems of drug degradation, drug contamination and other drug quality problems are continuously raised by the hospitals, drugstores and patients because some drugs were not properly transported, distributed and stored in accordance with the conditions required on the label of each drug during the logistics process ,despite the fact that the drugs are sensitive products and required special conditions, e.g. control over temperature, humidity, light, cleanness, sanitation, prevention of contamination and other factors encountered during transportation, distribution and storage. 

            This thesis, thus, aims to study the problems of Thai law on drug quality control, comparing them with foreign legislations, such as those of the United Kingdom and Singapore, as well as the guidelines of the World Health Organization and the European Union on the various stages of activities  in the drug logistic chain, in order to propose an appropriate legislative solution in the Thai context.