Enforcement of The Sale Of Drugs Act 1952 (ACT 368) on registered products in Malaysia / Ruzita Katap … [et al.]

In Malaysia, the Pharmaceutical Services Programme under the Ministry of Health Malaysia is the responsible authority to safeguard the sale and usage of medicinal products. The Sale of Drugs Act 1952 and its Regulations, the Control of Drugs and Cosmetics Regulations 1984 were promulgated to ensure product quality, efficacy and safety. The regulations provide for the establishment of the Drug Control Authority to regulate the pharmaceutical, traditional and cosmetic drugs industry, whereby the Pharmacy Enforcement Division, which is one of the main components of the Pharmaceutical Services Programme, is vested with the powers to enforce these Act and Regulations. It is crucial for the Pharmaceutical Services Programme to ensure that the enforcement of the Act and Regulations, and the enforcement activities under the Pharmacy Enforcement Division is carried out effectively and in accordance with the laws so provided in order to ensure public health and safety. Therefore, this study attempts to examine the Sale of Drugs Act 1952 and its Regulations, and the enforcement activities carried out under the Pharmacy Enforcement Division; and further to identify the weaknesses and problems of the two areas under study. The research adopts the qualitative approach which involved library based research and interviews. Accordingly, some recommendations for instance, constant revision of drug legislation, empowerment of drug regulatory authority, enhancement of monitoring and evaluation system and also enhancement of public education and protection programmes in order to overcome those weaknesses and problems are suggested.