PUTRAJAYA: The Health Ministry (MoH) has confirmed the health supplement "Beni Koji Choleste Help," which contains Red Yeast Rice (RYR), manufactured by Kobayashi Pharmaceutical Co. in Japan, is not registered in Malaysia.
National Pharmaceutical Regulatory Agency (NPRA ) director Rosilawati Ahmad, said in a statement today (April 1) this comes following a comprehensive review of the NPRA's registered product database.
"The review also revealed over a hundred other products containing RYR, manufactured by various companies, which have been registered in Malaysia," she said.
RYR is derived from the fermentation process of rice using a specific yeast strain called Monascus purpureus.
During this fermentation process, the predominant natural components are monacolins, with Monacolin-K being the most prominent.
The chemical structure of Monacolin-K is identical to that of lovastatin, a widely prescribed medication for managing blood cholesterol levels.
Consequently, she said products containing RYR (Monascus purpureus) must undergo registration with the Drug Control Authority (DCA) under either the traditional products or health supplements category.
She noted that the DCA has established limits for Monacolin-K in finished products, stipulating that it should not exceed one per cent and the daily intake of Monacolin-K should not surpass 10mg per day.
"The company is required to provide laboratory analysis certificates for the Monacolin-K content in both finished products and raw materials containing RYR," she said.
She added that all registered products containing RYR must comply with precise labeling criteria as outlined in the Drug Registration Guidance Document (DRGD) issued by NPRA.
This entails providing statements to inform consumers that the product contains naturally occurring lovastatin, along with potential side effects like body and muscle pain, as well as fatigue resulting from product consumption.
She also urged the public to only consume registered health products, which undergo safety and quality evaluations prior to approval.
"The MoH via NPRA, consistently monitors registered products to ensure their safety and high quality for consumers," she said.
Local and international media have earlier reported on the recall of these health supplement products, which were linked with reported deaths among consumers overseas. — Bernama