Products
The domestic pharmaceutical industry consists of manufacturers engaged in the process of drug production from research, development and licensing. The potential of the domestic pharmaceutical industry has been recognized by the Malaysian government which has identified it as a strategic industry which should be promoted.

Pharmaceutical products manufactured by the Malaysian pharmaceutical industry can be broadly categorized as:

1. Prescription
2. Over-the-counter (OTC)
3. Traditional medicines
4. Health and Food supplements

The Prescription medicines comprise patented and generic drugs, the sale and transaction of which are confined to doctors and pharmacists. 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 preparations such as eye preparations, injections (both large and small volume), soft gelatin 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.

Since 1986 when drug registration was started, the cumulative total number of applications received by the Drug Control Authority (DCA) as at the end of 2005 were, 16,554 for poisons (controlled medicines); 12,529 for non poisons; 28,546 for traditional medicines and 87,532 for cosmetics. As at the end of 2005 the number remaining on the register were 3,711 for prescription products (controlled medicines); 2,831 for OTC products (non poisons); 1,112 for traditional medicines and 82,792 for cosmetics.

Growth Rate
Over the last decade, the Malaysian pharmaceutical market grew at between 8 to 10% annually. The 2004 market size was estimated to be about RM3 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 relies, to a significant extent, on imports.

There are currently 296 manufacturers in Malaysia licensed by the Drug Control Authority. Of these, 87 are licensed to produce pharmaceuticals. There are also another 148 manufacturers licensed to produce traditional medicines and 61 for cosmetics.

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 10.7% between 1995 to 1999 in which the export value totaled RM280 million.

Research & 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 products with resultant 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 licensed by the DCA. http://www.bpfk.gov.my

The registrations 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 manufacturers in Malaysia are subjected to regular and random 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 PIC Code as Malaysia is currently a PIC/S member.

Medicines are regulated under the Poisons Act, the Dangerous Drugs Act and the Drugs Act. Medicine advertisements require prior approval by the Medicines Advertisement Board.

Malaysia is a member of the WTO and has acceded to the TRIPS agreement. Patents are registered and copyrights are protected.