While maintaining a relatively low profile, the Malaysian pharmaceutical industry has been expanding by some 8 to 10 per cent annually for the last five years. Currently estimated at 1.8 billion, the pharma industry in Malaysia has a well developed over-the-counter (OTC), traditional medicines and health and food supplements segments, apart from prescription drugs.
The market for prescription and OTC medicines is estimated at about US$395 million, while that of traditional medicines together with health and food supplements worth between US$526-US$790 million. The prescription medicines are comprised of patented and generic drugs, the sale and transaction of which are confined to doctors and pharmacists. The OTC, traditional medicine and health/food supplements may be sold by non-professional outlets to the public.
According to industrial estimates, 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 140 manufacturers licensed to produce traditional medicines. Health supplements are easily available from pharmacies, healthfood stores, supermarkets, direct-selling agents, and even on the internet with a prescription.
Local production of pharmaceuticals includes mostly generic drugs such as antibiotics and painkillers. The Malaysian pharmaceutical industry can now produce almost 80 per cent of the various categories in the Malaysian Essential Drugs List. The industry has the capability to produce almost all dosage forms, including sterile preparation such as eye preparations, injections (both large and small volume), soft gelatin capsules, time release medications and powders. In 1998, the government registered 7,416 prescription medicines and 8,873 OTC medicines while about 20,000 applications for traditional medicines were received, sources say.
A significant proportion-nearly 65 per cent -of the total turnover of Malayisan pharma market is derived from imports. There are 11 US.-based pharmaceutical companies in Malaysia with accumulative investment of an estimated RM 104.6 million. Their main activities in Malaysia involve manufacturing, distribution and promotion of medical and pharmaceutical products. According to the Pharmaceutical Association of Malaysia, the apex body representing MNCs, its sales revenue in 2001 was about RM 1 billion. It currently employs about 1,751 workers.
An increasingly growing demand for plant-derived products in the form of dietary supplements has become vogue in the Malaysian pharma market, of late. As per Nutrition Society of Malaysia, dietary supplements include preparation of vitamins, minerals, amino acids and mixtures of these nutrients, as well as herbs and other botanicals. Malaysians spent an average of US$17.30 a month on health supplements. The local dietary supplements market has seen steady growth over the years. This has also resulted in more pharmaceutical companies including dietary supplements in their product line.
The National Pharmaceutical Bureau (NPB) estimates the market for the health supplement is still relying heavily on imports as the local production is very low and the herbal manufacturing industry is in its infancy stage. NPB, which regulates the pharmaceutical sector under the Ministry of Health regulates the phar-maceutical sector passes off herbal, health and dietary supplements, and traditional medicines as non-poison over-the-counter, or as traditional products. The terms are not legally defined but are accepted to mean products used to supplement the diet by way of oral intake. These supplements usually take the form of pills, powder, capsules or liquid shakes.
The registration of the products requires proof of efficacy, quality and safety, and are subject to stringent screening and testing as well as regular and random post-marketing surveillance and testing. All manufacturers, importers and wholesalers are required to register with the Drug Control Authority of NPB. American companies need to appoint local agents to represent them in the registration. The US is the biggest exporter of health supplements to Malaysia.
The majority of food supplements sold in Malaysia via direct selling, pharmacy, supermarkets and Chinese medical halls. The most popular dietary supplements among Malaysians are vitamin C, E, B complex, multivitamins, folic acid and calcium. The popular natural supplements include evening primrose oil, Omega 3 fish oil, gingko biloba, lecithin, royal jelly, spirulina, ginseng, garlic oil, and cold liver oil.
Observers see a huge potential in the local herbal medicine market in Malaysia. The incredible variety of plant species found in the country's jungles gives the industry a tremendous advantage in terms of discovering and developing new pharmaceutical products for the world market.
Also, Malaysia has one of the highest manufacturing standards in pharmaceuticals in the region. And it does not have the infrastructure problems of Indonesia, language problems of Thailand and cost problems of Singapore.
Malaysia has become one of the first countries in the Association of Southeast Asia Nations (ASEAN) to gain membership in Europe's Pharmaceutical Inspection Cooperation Scheme (PIC/S) in January 2002. The PIC/S is conceived by the European Free Trade Association, which upholds good manufacturing practices. It involves cooperation between participating authorities in inspection, exchange of information, experience in good manufacturing practices, and training of inspectors. The recognition has enabled Malaysian pharmaceutical companies more easily to export their products to PIC/S members, mainly in the European Union.
Exports, too, grew significantly over the last few years, figures suggest. The increasing awareness by local manufacturers of the export potential of Malaysian pharmaceuticals had resulted in an average growth of 10.5 per cent for past 3-4 years.
A strong emphasis is also 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.