Spearheading Herbal Quality

. Last Updated: 28 January 2025Hits: 63

The Malaysian government is aware of the potential of the herbal industry as well as the consumers’ demand for high-valued herbal products. Since 2011, under the Entry Point Project (EPP) High-Value Herbal Products, which is included in the herbs sub-sector of NKEA agriculture, the Malaysian Herbal Monograph (MHM) has been developed to ensure quality control of herbal raw materials.

What is a monograph? It contains specifications for the identification of plants using single chemical entities known as ‘marker compounds’ or profiling techniques analyzed with chromatographic methods.

Why is a monograph important? It can strengthen value chain supplies since it is applicable to raw material, extracts or herbal products and enhance the research and development of herbs.

Are monographs developed in other countries? Yes herbal monographs are published in different countries (e.g England, Europe, China, India, Japan, Indonesia) which consist of different layouts and provide a variety of information that represents the quality assurance of the herbal medicine.

Currently, a total of 90 monographs have been developed by the MHM Committee, which consists of seven agencies (IMR, NPRA, FRIM, MARDI, UKM, USM and UPM). The monographs are available at the Global Information Hub on Integrated Medicine website (www.globinmed.com) under the Medicinal Herbs and Plants Database scope.

From 2021 onwards, the MHM committee has been working to establish the Malaysian Herbal Pharmacopoeia (MHP), a legal document containing a list of selected drugs and their preparations, including data on identification, purity, and potency.

What is the difference between MHM and MHP? The MHM document is non-obligatory and serves as reference material for herbal industry, providing detailed information on the plants. The MHP, on the other hand, is a more concise document that contains quality control aspects, identification tests, purity tests, and assay (quantification of active markers). It will also be legally binding and required for product registration.

How will MHP benefit the herbal industry? The document will serve as a standard reference for regulatory or registration applications for herbal products, depending on their usage claims. It will also differentiate the quality of your herbal products compared to low quality or adulterated ones.

Is MHP part of national plans? Yes, the establishment of MHP is listed under the Traditional & Complementary Medicine Blueprint 2018-2027 (Healthcare) and Dasar Bioteknologi Negara 2.0.

Overall, the herbal monograph represents the most comprehensive and critically reviewed body of information on herbal medicine as it elaborates on the scientific information on the safety, efficacy, and quality control/quality assurance of widely used medicinal plants, in order to facilitate their appropriate use. Therefore, the MHM/ MHP development is crucial in spearheading the quality of our local herbal products that meet the regulatory requirements so that it can be marketed locally and internationally.