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Products The domestic pharmaceutical industry consists of manufacturers engaged in the process of drug production from research, licensing or otherwise. The potential of the domestic pharmaceutical industry has been recognised by the Malaysian government who has identified it as a strategic industry which should be promoted. Pharmaceutical products manufactured by the Malaysian pharmaceutical industry can be broadly categorised as :
The prescription medicines comprise patented and generic drugs, the sale and transaction of which are confined to doctors and pharmacists. The OTC, traditional medicines and health/food supplements may be sold by non-professional outlets and to members of the public. The Malaysian pharmaceutical industry has the capability to produce almost all dosage forms, including sterile preparation such as eye preparations, injections (both large and small volume), soft gelatine capsules of various sizes and shapes, time release medications and powders for reconstitution. The industry can now produce almost 80% of the various categories in the Malaysian Essential Drugs List. In 1998, the government registered 7,416 prescription medicines and 8,873 OTC medicines while about 20,000 applications for traditional medicines were received. Growth Rate Over the last decade, the Malaysian pharmaceutical market had been growing at between 8 to 10% annually. The 1999 market size was estimated to be about RM1.4 billion for prescription and OTC medicines. The market for traditional medicines together with health and food supplements was estimated to be about RM2 billion. However the market still rely, to a significant extent, on imports. There are currently 72 manufacturers in Malaysia licensed by the Drug Control Authority. Of these, 32 are licensed to produce prescription medicines while the rest are producers of OTC medicines, There are also another 140 manufactures licensed to produce traditional medicines. Exports Another significant development in the industry is the growth in pharmaceutical exports. The increasing awareness by local manufacturers of the export potential of Malaysian pharmaceuticals had resulted in an average growth of 10.&% between 1995 to 1999 in which the export value totalled RM280 millions. Research and Development A significant development of the industry over the last decade is the strong emphasis placed by local manufacturers on research and development, particularly in areas of product innovation and improvement as well as in bio-pharmaceutics and natural resources with resulted patents. Regulation The manufacture and marketing of pharmaceutical products in Malaysia are as heavily regulated as in most developed countries. All medicines marketed in Malaysia are required to be registered by the Drug Control Authority(DCA) of the Ministry of Health. All manufacturers, importers and wholesalers are required to the by DCA. The registration of prescription and OTC medicines requires proof of efficacy, quality and safety, and are subjected to stringent screening and testing as well as regular and random post-marketing surveillance and testing. All manufacturer in Malaysia are subjected to regular and surprise inspection by DCA inspectors. To be licensed, manufacturers must be in full compliance with the Code of Good Manufacturing Practice which is currently based on the World Health Organisation Code. However the industry is presently adopting the PIC Code as Malaysia is in the process of joining the PIC/S. Prescription or scheduled medicines are regulated under the Poisons Act and the Dangerous Drugs Act similar to that of the United Kingdom. Medicine advertisements require prior approval by the Medicines Advertisement Board. Malaysia is a member of the WTO and has accede to the TRIPS agreement. Patents are registered and copyrights are protected. |
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