Biotechnology – Life Sciences Industries in Malaysia
Biotechnology – Life Sciences Industries in Malaysia
Malaysia's life sciences industry encompasses three major sectors,
namely, biotechnology, pharmaceuticals and medical devices.
Biotechnology
The biotechnology industry encompasses various biotech products and
services derived from the utilisation of technology involving the
application of living organisms, their parts and components, or
biological systems and processes.
Malaysia is one of the world's 12 mega biodiversity centres with
abundant natural resources in flora, fauna and marine ecosystems. The
government is committed to promoting this industry as one of the new
growth areas and its concerted efforts have resulted in the
realisation of more joint-ventures and collaborations between local
and foreign parties in undertaking research and development (R&D)
activities for the production of vaccines, diagnostic kits and other
biotech related products.
Malaysia also offers skilled human resources, where Malaysia's
current National Education Policy emphasises on science and
technology. In Malaysia, there are 13 universities offering
biotechnology programmes with about 3,000 undergraduates studying
biotechnology annually, besides other post graduates programmes. The
Malaysian government estimates that over the next five years, there
will be about 23,000 research personnel and more than 5,000 R&D
scientists available in this field.
Malaysia also provides strong R&D support to investors. Due to its
agrarian roots, Malaysia has a well-established R&D expertise in the
agriculture and food industries, especially industrial crops, food
crops and ornamentals. There are also several science and technology
parks, incubation centres and clinical trials centres catering to the
needs of biotechnology and R&D activities. Examples of such
facilities are Technology Park Malaysia, Kulim Hi-Tech Park, Centre
for Health Innovation and Medical Enterprises (CHIME), UKM-MTDC Smart
Technology Centre and Malaysian Institute for Nuclear Technology
Research (MINT).
The Malaysian government is implementing new initiatives to
accelerate the development of the biotechnology industry. Measures
have been undertaken to integrate research activities at the state
level, encourage industry participation and attract investments and
quality human talents, provide specialised commercialisation support
services (patents, legal advisory, business plans, marketing plans
and partners sourcing).Priority areas identified include plant
biotechnology, animal biotechnology, medical biotechnology, food
biotechnology, industrial and environment biotechnology,
biopharmaceuticals, molecular biotechnology and bioinformatics.
The focus areas for futher development in the biotechnology industry
are:
- Food biotech/Agro biotech
- Biopharmaceuticals (antibodies and vaccines)
- Nutraceuticals
- Biodiagnostics
- Industrial enzymes
- Strategic alliances and research partnership/joint discovery of
bioactive compounds for healthcare
The Malaysian pharmaceutical industry has the capability to produce
almost all dosage forms, including sterile preparations such as eye
preparations, injectibles, soft gelatine capsules and time release
medications.
Malaysian pharmaceutical manufacturers are focusing on high-margin
niche segments, adding value to existing products through improved
drug-delivery technologies, and increasingly moving into
biopharmaceuticals and branded generics including biogenerics in
order to remain competitive.
Local manufacturers have also developed and launched off-patent
generics and herbal products using their own brands. Currently, the
local industry is producing about 25 - 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. Total exports in 2004
amounted to RM498 million (US$130 million). 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.
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. As at
31st. December, 2004, a total of 205 pharmaceutical companies with
Good Manufacturing Practices certification have registered with the
DCA. Of these, a total of 74 companies are involved in the production
of modern medicines comprising mainly analgesics, antacids, anti -
hypertensives, diuretics, antibiotics and anti-histamines in the form
of tablets, capsules, drops, powders, creams, ointments, injectibles,
syrups, ophthalmic and nasal preparations. The remaining 131
companies are local traditional and herbal medicine manufacturers.
Malaysia's Intellectual Property laws conform to international
standards and provide adequate protection to both local and foreign
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, an indication of Malaysia's
commitment to providing a more conducive environment for better
implementation of IP rights.
Malaysia is also a signatory to the Agreement on Trade Related
Aspects of Intelelctual Property Rights (TRIPS). In addition to this,
Malaysia had ratified the Patent Co-operation Treaty (PCT) in 2003,
facilitating patent registration and consequently protection to
foreign inventions.Currently, the manufacture of pharmaceuticals and
related products (which include pharmaceutical goods, clinical
diagnostic reagents, gelatine or gelatine products, intravenous,
dialysis or irrigating solutions, vaccines, medicaments) are eligible
for normal Pioneer Status or Investments Tax Allowance incentives.
The development, testing and production of pharmaceuticals promoted
under biotechnology is eligible for High Technology Pioneer Status or
Investments Tax Allowance incentives.
Medical Devices
Malaysia continued to maintain its position as the world's leading
producer and exporter of medical gloves and catheters, supplying 80
per cent of the world market for catheters, and 70 per cent for
rubber gloves.
The production of medical gloves has moved up the value chain, with
higher quality and specialty gloves being manufactured such as low
protein, powder free medical gloves, safety gloves and clean room
gloves.Other medical device products manufactured in Malaysia include
syringes, surgical equipment, blood transfusion sets, blood pressure
transducers, dialysis solutions, medical gases, hypodermic /spinal/
AV fistula needles, medical tubes & bags, diagnostic radiographic
equipment, orthopaedic products and procedural kits.
Although the medical industry in Malaysia is currently concentrated
on the rubber-based products, more companies are moving into the
manufacturing of non-rubber based products made from plastics,
silicone and metal alloys.
The medical devices sector is expanding its manufacturing value chain
by moving from basic processes and conventional assembly to product
and process research & development, design and prototyping,
distribution and logistics.
The medical devices industry in Malaysia are currently not subject to
any regulations on quality with regard to imports, exports and local
production. Most medical products manufactured in Malaysia are self-
regulated and conform to internationally recognised quality standards
such as the Food and Drug Administration (United States), Department
Of Health (United Kingdom) and Bundesgesundheitsamt (Germany).
However, the Ministry of Health (MOH) is drafting the medical device
regulations in Malaysia and plans for registration of manufacturers,
importers and distributors of medical devices to commence in 2007. It
has been agreed in principle that the regulations would be aligned to
the guidelines drawn up by the ASEAN Harmonisation Working Party
(AHWP) and the Global Harmonisation Work Force (GHTF).
Investment opportunities are available for the following products :-
Electromechanical devices (e.g. electrocardiograph)
Active implantable devices (e.g. cardiac pacemaker, neuro stimulator)
Ophthalmic & optical devices
Other non-rubber based medical equipment
The goal of DK Malaysia Development, LLC is to promote investment,
business development, trade, and tourism to Malaysia and DK Malaysia
serves as a consultant to Malaysian government agencies (MITI -
Ministry of Trade and Industry Malaysia, MIDA - Malaysian Industrial
Development Authority and MATRADE - Malaysia External Trade
Development Corporation).
Take care and All the best,
Fred Plimley
Moderator - Linkedin Malaysia
President - DK Malaysia Development, LLC
f.plimley@dkmalaysia.com
http://www.linkedin.com/in/fredplimley
(206) 309-0685
(909) 214-8783
(+44) 020 7193 7317
Skype ID: fredplimley
AZhttp, Inc.


