The Malaysian pharmaceutical industry can be categorized as prescription, over-the-counter (OTC), traditional medicines and health and food supplements. 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 and to the public.
The Malaysian pharmaceutical market has been growing at between 8 to 10 % annually. The current market size is estimated at about US$395 million for prescription and OTC medicines. The market for traditional medicines together with health and food supplements is estimated at between US$526-US$790 million. The market still relies 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 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. Consumers have many choices and thus need to decide on what to believe in and what not to, evaluate the authenticity and accuracy of the claims, and determine the efficacy and safety.
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 move is expected to raise the standards of the local pharmaceutical industry. The PIC/S is conceived by the European Free Trade Association, which upholds good manufacturing practices.
Nutritional supplements include vitamins which is defined as complex chemical substances that are needed for the functioning of the body, but that generally cannot be produced by the body and must therefore be obtained from food or nutraceuticals.
Nutraceutical (sometimes used synonymously with functional food) is a product isolated or purified from foods and generally sold in medicinal forms not usually associated with food for the purpose of physiological benefits or to provide protection against illness.
Herbal medicines include herbs and traditional medicine, which means any product employed in the practice of indigenous medicine, whereby the drugs used consist of one or more naturally occurring substances of plant, animal, or mineral or part thereof, or in extracted form or non-extracted form, and any homeopathic medicine. Indigenous medicine means a system of treatment and prevention of diseases involving the traditional use of naturally occurring substances. Herbal medicines are widely used in the Malay, Chinese and Indian traditional treatment.
Homeopathic medicine means any drug in a pharmaceutical dosage form that is used in the homeopathic therapeutic system in which diseases are treated by the use of minute amounts of such substance which is capable of producing in healthy persons symptoms similar to those of the disease being treated. Homeopathic medicines in finished dosage forms have to be registered with the Drug Control Authority before they can be imported and sold in the country.
Market Trends
According to the 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. The market for traditional medicines and other health foods, such as herbs, foods, and beverages enriched with supplements was estimated to be worth US$526 million.
The trend of going back to nature is gaining popularity in Malaysia and globally. Demand for natural health supplements is increasing. The market growth may be linked to society's growing awareness and affluence. More Malaysians are taking active measures to ward off illnesses and maintain good health by taking supplements. As a result, demand for health supplements such as vitamins and herbal remedies has gone up. This has also resulted in more pharmaceutical companies including dietary supplements in their product line.
From 1991 to 2000, the number of OTC products registered with the Drug Control Authority, a division under the National Pharmaceutical Control Bureau, has shown a significant increase from 3,331 products to 6,072, while about 20,0.
The estimated market for nutritional supplements, nutraceutical and herbal medicines is about US$526 million, with much of the market still relying heavily on imports. The local production is still very low and the herbal industry is still in its infancy stage. There is huge potential in the local herbal medicine market.
In Malaysia, the National Pharmaceutical Bureau, which is under the Ministry of Health regulates the pharmaceutical sector. Herbal, health and dietary supplements, and traditional medicines are regulated 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. They are of nutritional value as they contain vitamins, minerals, amino acids and natural substances.
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 the National Pharmaceutical Bureau. American companies need to appoint local agents to represent them in the registration.
The US is the biggest exporter of health supplements to Malaysia. US brands are well accepted and are perceived to be of high quality. The majority of food supplements sold in Malaysia is via direct selling, pharmacy, supermarkets and Chinese medical halls. The most popular vitamins and minerals among Malaysians are vitamin C, B complex, E, multivitamins, folic acid and calcium. Among the popular natural supplements are evening primrose oil, Omega 3 fish oil, gingko biloba, lecithin, royal jelly, spirulina, ginseng, garlic oil, and cold liver oil.
- SOURCE: National Pharmaceutical Bureau, Malyasia