According to you, what are the biggest challenges in the Malaysian market and how can it be handled?
One of the major challenges facing MOPI members is the increasing cost base. With the advent of the minimum wage legislation, all members will be affected due to the manual component of the industry. Whilst automation is a possibility, in some cases, the size of Malaysian demand does not make automation an economical option. In addition, ever increasing cGMP standards also have an impact on reinvestment levels required in order to comply with the ever-evolving standards.

Another challenge is clarity on patent position. In many cases, it has been noted by industry players that patents on innovator drugs expire much later in Malaysia relative to originating country or even among regional markets. This has led to the inability of Malaysian companies to be first in the market with any generic.

The industry has the potential to not only replace imported high value pharmaceutical products but to also develop a strong position as a major exporter of generic pharmaceuticals with the right support from the Malaysian government. The combination of a knowledgeable workforce, strong regulatory framework and relatively cost competitive infrastructure makes Malaysia an ideal location for current and future pharmaceutical manufacturers to use Malaysia as a manufacturing and export base to cater for the region.

What actions are being taken by MOPI to boost the pharmaceutical industry of Malaysia?
MOPI is representing the industry in engagement with both domestic pharmaceutical regulatory agency (Malaysian Drug Control Authority) and international pharmaceutical regulatory agencies (TGA, US FDA etc).

We are assisting our member companies in meeting PIC/s regulatory changes, provide them platform for cGMP training for member companies and represent the industry in lobbying for government support for the industry. MOPI also represent the industry in regulatory regional meetings e.g. ASEAN Consultative Committee for Standards and Quality (ACCSQ) as member of ASEAN Pharmaceutical Club (APC). The association establishes code of conduct for the industry in line with best practices.