Malaysian manufacturers have demonstrated their capabilities and capacities to produce pharmaceutical products in almost all dosage forms, including sterile preparations, injectables, and time-release medications, as well as developed and launched off-patent generic drugs and herbal products under their own brands. Malaysia is a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation/Scheme (PIC/S), enabling locally-manufactured pharmaceutical products to be accepted globally, particularly in other PIC/S member countries.
Major local companies in the industry include Pharmaniaga, CCM Pharmaceuticals, Kotra Pharma, Hovid and Xepa-Soul Pattinson; some notable foreign-owned manufacturers, such as Oncogen Pharma, Y.S.P. Industries, GlaxoSmithKline (GSK), Ranbaxy, and Biocon, also have a presence in the country. Responding to the growing demand for such products in the SEA region, leading Malaysian pharmaceutical companies are moving into the production of biologics, oncology drugs, and high value-added generic compounds.
As at 2017, a total of 251 facilities were licensed by the Drug Control Authority (DCA), Ministry of Health Malaysia. They are categorised into 158 (63%) facilities that produce traditional medicine, 83 (33%) facilities that produce pharmaceuticals and 10 (4%) facilities that produce veterinary products. A total of 23,650 pharmaceutical products are DCA-registered, including traditional products (51.6%), prescription medication (27.7%), non-prescription/over-the-counter medication (13%), health supplements (4.7%), and veterinary medicine (3%).
Investors seeking a niche in the pharmaceutical industry with significant growth potential should consider the halal sector. The halal pharmaceutical industry globally is a multi-billion dollar industry with expenditures of US$75 billion in 2017, growing to an estimated US$132 billion by 2021. Malaysia is fast becoming recognised as the leading global halal hub, as well as the global reference and trade centre for the mainstream halal industry. It had also established the world’s first halal pharmaceutical standard, MS2424:2012 Halal Pharmaceutical – General Guidelines, with JAKIM’s Halal Hub Division being the first accreditation body in the world to certify halal pharmaceutical products.
Malaysia’s strength lies in its well-developed infrastructure, paired with the presence of a credible certification authority, Islamic financial institutions and products, and parks, logistics, and testing labs specifically catering to the halal trade and industry. This is complemented by Government support in laying the foundation for halal industry development in Malaysia. Government agencies, such as MIDA, Halal Industry Development Corporation, Malaysian Technology Development Corporation, and SME Corporation Malaysia, offer various facilities and initiatives, including tax incentives, assistance with funding, training and consultancy services, and skills upgrading programmes. For instance, tax incentives for halal industry players operating in halal parks have been extended to include manufacturers of nutraceutical and probiotic products.
Nine pharmaceutical projects approved in 2017, comprising investments of RM517.9 million. These approvals indicated major breakthroughs in the ecosystem, as they enabled more sophisticated, higher value-added, and frontier pharmaceutical products to be manufactured in Malaysia.