Pharmaceutical companies in Malaysia have the ability to manufacture medicines in all forms of dosages like tablets, capsules, liquids, ointments, and active pharmaceutical ingredients (API). Local manufacturers have developed and launched off-patent generics and herbal products using their brands. Total exports last year totalled Ringgit Malaysia (RM) 513 million.
With the inclusion of Malaysia in Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation/Scheme (PIC/S), the exports of pharmaceutical products have received an impetus, especially amongst the member nations that comprise Australia, Canada, and the European Union.
The main regulatory power on the production, import and sale of pharmaceuticals in Malaysia is the Drug Control Authority (DCA) of the Ministry of Health. About 234 pharmaceutical companies with Good Manufacturing Practices certification have registered with the DCA.
Out of these, a total of 67 companies are engaged in the production of modern medicines including analgesics, antacids, diuretics, antibiotics and anti-histamines in the shape of tablets, capsules, drops, powders, creams, ointments, injectibles, syrups, ophthalmic and nasal preparations. The rest of 167 companies are local traditional and herbal medicine manufacturers.
Intellectual Property laws of the country meet international standards and provide sufficient protection to both local and overseas investors. The Intellectual Property Corporation of Malaysia (IPCM) was formed in March, 2003 taking over the functions of the Intellectual Property Division (IPD) of the Ministry of Domestic Trade and Consumer Affairs Malaysia. Malaysia is also a participant to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Malaysia has agreed to the Patent Cooperation Treaty (PCT) aiding patent registration and as a result protection to foreign inventions. The PCT allows the filing of an international patent application either immediately or within one year of filing of a patent application in any of the member countries.
The Clinical Research Centre (CRC), having a network of 17 centres around the country, operates as the one-stop-centre by providing a single point of contact to access all Ministry of Health hospitals and clinics to carry out clinical trials in Malaysia. These clinical trial centres have connections with more than 50 general and district hospitals, and more than 100 health clinics as possible 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.
At present, the manufacture of pharmaceuticals and related products are entitled for normal Pioneer Status or Investments Tax Allowance incentives. The development, testing and production of pharmaceuticals endorsed under biotechnology are entitled for High Technology Pioneer Status or Investments Tax Allowance incentives.
Last Updated on: 18-11-2009