The Malaysian government has identified the domestic
pharmaceutical industry as an industry to be developed and
promoted under it’s new economic development plan.
Pharmaceutical products manufactured can broadly be
- Prescription Medicine
- OTC (over the counter) Medicine
- Herbal and Health Supplements
- Traditional Medicine
These are produced in almost all possible pharmaceutical
In 1986, drug registration was introduced in Malaysia and the
Drug Control Authority (DCA) established. All drugs/medicine
in pharmaceutical dosage forms and cosmetics have to be
registered before sale and marketing is permitted in the
In 2009, the total market size for Prescription and OTC
medicine was estimated at RM4.5 billion while the traditional
medicine and health supplements market was estimated at
RM3 billion. Market growth has been fairly consistent at
between 8% - 10% annually for the past several years.
Of the 250 DCA licensed manufacturers in 2011, 74 are
licensed to manufacture prescription and OTC medicines
while the remaining 176 are licensed traditional medicine
There are a further 207 licensed cosmetic/toiletries
Malaysian manufacturers currently export to countries in South East Asia, Africa, and the Middle East with new markets being explored beyond these countries. Growth in exports has been steady at between 10% to 12% annually.
Research & Development
Strong emphasis is placed on R & D, both in-house and in
collaboration with Universities, by domestic manufacturers. In
some instances, collaborative work is also being undertaken with innovator companies. R & D outcomes in bio-pharmaceutics and traditional medicines have resulted in several patent filings.
The manufacture and marketing of pharmaceutical products in Malaysia is strongly regulated as is in most developed countries.
Malaysia was admitted a member of PIC/S in 2002 and
manufacturers are required to be in compliance with the CGMP of PIC/S. Please refer to the regulatory agency:
http://www.bpfk.gov.my for more details.
Malaysia is also a member of the WTO and has acceded to the TRIPS agreement. Patents are registered and