Malaysia Introduces New Halal Pharmaceuticals Standard

Malaysia introduced a new standard for Halal pharmaceuticals today in a move to strengthen the integrity within the manufacturing and servicing of medicines and health supplements.

The new Malaysian Standard MS 2424:2010 (P): Halal Pharmaceuticals: General Guidelines will address the entire pharmaceuticals industry’s supply chain – from processing to handling, packaging, labelling, distribution, storage and display of medicines and health supplements.

In accordance to the International Organization for Standardisation (ISO) processes, a public consultation forum was held today to review the newly developed MS, in an event held in Kuala Lumpur which attracted more than 100 participants from the industry.

As of 31 January 2011, Standards Malaysia has produced a total of 6,344 MS'es.

Developed by the Industry Standards Committee on Halal Standard (ISC-I), the document has undergone every consensus-based processes with all the relevant parties including the Government, private sector, NGOs, researchers and professional bodies, as set out by ISO.

Various organisations made up the working committee of ISC-I, including Standards Malaysia, JAKIM, the Malaysian Ministry of Health (MOH), the Halal Industry Development Corporation (HDC), the National Pharmaceutical Bureau (NPCB), the Ministry of International Trade and Industry (MITI),the Ministry of Domestic Trade, Co-operatives and Consumerism (MDTCC), SIRIM Berhad, higher learning institutions as well as the private sector.

The new Halal pharmaceutical standard, codenamed MS2424:2010, is a general guideline that describes the requirements and critical areas in the manufacturing and handling for Halal pharmaceuticals. This national standard aims to serve as the basic document of reference for production purposes.

The introduction comes on the back of Malaysia’s current campaign to incorporate Halal considerations towards achieving an integrated Halal lifestyle, and also in line with the Strategic Reform Initiatives (SRI) for the Economic Transformation Programme (ETP), where standards have been identified as one of the drivers that can propel economic activities to transform and grow the Malaysian economy.

In 2008, US-based consulting company IMS Health Inc. estimated that the global pharmaceutical market is worth approximately US$770 billion a year. With a conservative growth rate of between 4.5-5.5%, this forecast value can easily exceed US$820 billion a year, a trend which is expected to continue growing between 4-6% beginning this year through till 2013.

Malaysia currently exports its pharmaceutical products to the surrounding ASEAN countries including in Singapore, Vietnam, Brunei Darussalam and Thailand, which accounts for approximately 50% of the total products’ value. According to the Ministry of International Trade and Industry (MITI), total value for the overall pharmaceutical industry in Malaysia amounted to RM814.2 million in 2009, an increase of 43.6 per cent from RM567.1 million in the previous year.

Malaysia, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) has greater access to key export markets including Europe, Canada and Australia. Malaysia is also the only OIC country that enjoys PIC/S visibility, making the newly introduced Halal Pharmaceutical standard even more significant, and in line with Malaysia’s Economic Transformation Programme (ETP) for Healthcare.

Other potential export destinations that have yet to be fully explored and penetrated include the US, Germany, Hong Kong SAR and Chinese Taipei.

Adapted from Press Release.