Industries in Malaysia
Malaysian pharmaceutical industry has shown a progressive growth over the years, particularly over the last one decade. The industry has invested substantially to upgrade itself in the last few years to meet the latest Good Manufacturing Practices (GMP) requirements, in accordance with the domestic as well as international Guidance. Currently the industry has the capacity to produce medicines in all dosage forms e.g. tablets (coated & non-coated), capsules (hard and soft gelatine), liquids, creams, ointments, sterile eye drops, small volume injectable (ampoules and vials), large volume infusions, dry powders for reconstitution and active pharmaceutical ingredients (API).
Local manufacturers have also developed and launched off-patent generics and herbal products using their own brands. Currently, the local industry is producing about 30 per cent of the domestic demand, as well as exporting to the Asia-Pacific Rim countries, the Middle East, Africa, Latin America and Europe. Leading Malaysian companies are also moving into the production of biologics drugs, oncology and high value-added generic compounds in-line with the growing demands in this region.
The principal regulatory authority on the production, import and sale of pharmaceuticals (including traditional medicines) in Malaysia is the Drug Control Authority (DCA) of the Ministry of Health. To date, a total of 246 pharmaceutical premises with Good Manufacturing Practices certification have registered with the DCA.
Of these, a total of 51 premises are licensed to produce modern medicines comprising mainly analgesics, antacids, anti-hypertensive, diuretics, antibiotics and anti-histamines in the form of tablets, capsules, drops, powders, creams, ointments, injectable, syrups, ophthalmic and nasal preparations. The remaining 172 premises are licensed to produce local traditional and herbal medicines.
Malaysia is one of the few countries in the region that have been accepted into the Pharmaceutical Inspection Cooperation/Scheme (PIC/S). With the admission of Malaysia as a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation/Scheme (PIC/S) in January 2002, the country's exports of pharmaceutical products received a boost, especially among the member countries, which include the EU, Australia and Canada.
Equally attractive is the increasing global demand in halal pharmaceuticals which offer companies the opportunities to capitalise on local expertise in halal production and the global acceptance of Malaysia's halal certification as well as increasing recognition of its halal products.
Under the Healthcare National Key Economic Area (NKEA) sector, one of the key recommendations is to promote manufacturing of pharmaceuticals. New investments in the state-of-the-art technologies and compliance with international standards have enabled Malaysian companies to be strategic outsourcing partners for MNCs.
Increasingly health-conscious Malaysians have contributed to the growth of OTC food/health supplements as well as herbal and traditional medicines. This is also in line with the agriculture NKEA to capitalise on Malaysia’s competitive advantage by leveraging on Malaysia’s biodiversity, including developing diverse natural herbs into premium herbal products.
To further support the development of the pharmaceutical industry in Malaysia, increasing efforts are being undertaken by the Government to develop the clinical trial services sector. Under the purview of the National Institute of Health of the Ministry of Health (MOH), a Clinical Research Centre (CRC) has been established to conduct clinical trials, clinical epidemiology and economic research, and manage complex medical databases. The CRC comprising a network of 27 centres around the country acts as the one-stop-centre by providing a single point of contact to access all Ministry of Health hospitals and clinics to conduct clinical trials in Malaysia. These clinical trial centres have linkages to more than 50 general and district hospitals, and more than 100 health clinics as potential sites for clinical trials with access to 550 clinical investigators and 17 million patients from diverse therapeutic areas in the public health care system in Malaysia.
Malaysia has nine international contract research organisations (CROs) operating in its shores and four local CROs. The country has 138 secondary and tertiary Ministry of Health (MOH) hospitals that service over 15 million patients in various therapeutic areas, which has generated about 175 active investigators. This is merely a fraction of the approximately 2800 specialists at MOH facilities (in total there are 5000 specialists from both the public and private sectors). (Source: Contract Research at MOH Hospitals. Berita MMA 2011(January):17-18).Currently, the manufacture of pharmaceuticals, biopharmaceuticals, nutraceuticals, microbials and probiotics are eligible for Pioneer Status or Investments Tax Allowance incentives. The development, testing and production of pharmaceuticals promoted under biotechnology are eligible for High Technology Pioneer Status or Investments Tax Allowance incentives.
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