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 standards and regulations. 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 while the other 70 per cent are imported pharmaceutical products that are not available locally. Some of the local-made products are also exported 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 Drug Control Authority (DCA) under the Ministry of Health is the principal regulatory authority that controls the production, import and sale of pharmaceuticals (including traditional medicines) in Malaysia. As of November 2015, a total of 264 pharmaceutical premises with GMP certification have registered with the DCA.
Of these, a total of 77 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. Another 178 premises are licensed to produce local traditional and herbal medicines while the remaining nine (9) premises are veterinary premises.
Malaysia is one of the few countries in the region that has been accepted into the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) since January 2002. Being a member of the PIC/S, the country's exports of pharmaceutical products have shown an upwards trend, especially to 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. Government has also expanded the scope of EPP3 - Malaysian Pharmaceuticals to include manufacturing of biopharmaceuticals comprising biologics and vaccines and over-the-counter (OTC) products. The Government also encourages strong ties between local companies and MNCs through contract manufacturing collaborations towards greater market access. Through concerted efforts by the Government, industries and other stakeholders, Malaysia is poised to become a significant driver in the pharmaceuticals industry.
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. The National Institute of Health of the Ministry of Health (MOH) has established the Clinical Research Centre (CRC) to conduct clinical trials, clinical epidemiology and economic research, and manage complex medical databases. The CRC comprising a network of 30 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. In addition, Malaysia has ten (10) international contract research organisations (CROs) operating in its shores and five (5) local CROs.
The recent and major focus of high value-added pharmaceuticals is on the biopharmaceutical products. Established pharmaceutical companies are now focusing on biopharmaceuticals as there is a huge potential demand globally. The number of patents applied every year has been increasing at 25 per cent annually, with more than 1,500 biomolecules undergoing clinical trials. Potential niche pharmaceutical products which have unique formulations or utilise special ingredients, such as orphan drugs, oncology drugs, drugs for tropical diseases and targeted drug deliveries, are also expected to create a significant market segment.
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 products involving biotechnology activities are promoted under Promotion of Investment Act, 1985 and eligible for Pioneer Status or Investments Tax Allowance incentives for High Technology project.