Registration works


  • Health
  • Sunday, 11 May 2003

BY HOOI YOU CHING

IN Malaysia, the Drug Control Authority (DCA) is involved in the registration of pharmaceutical products and cosmetics; licensing of premises for importer, manufacturer and wholesaler; monitoring the quality of registered products in the market and Adverse Drug Reaction Monitoring. In 1992, traditional medicines came under the regulation of the DCA.  

In December 2001, the DCA suspended the registration of products containing Kava Kava after 30 cases of hepatotoxicity (liver damage) associated with the use of Kava Kava were reported. In the same year, the DCA also cancelled the registration of products containing herbs associated with aristolochic acid after it caused adverse effects towards the kidney such as nephropathy and end-stage renal failure.  

Under the Control of Drugs and Cosmetics Regulations 1984, dietary supplements like probiotics, chitosan, glucosamine, spirulina, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, extract of chicken with herbs must be registered. Other products that need to be registered include pharmaceutical products containing scheduled poisons, pharmaceutical products containing non-scheduled poisons (OTC) such as anti-dandruff shampoo, oral healthcare. Registration requirements also apply to traditional medicine – any product employed in the practice of indigenous medicine, whereby the drugs used consist of one or more naturally occurring substances of plant, animal or mineral or part thereof, or in extracted form or non-extracted form, and any homeopathic medicine. 

The National Pharmaceutical Control Bureau (NPCB) is set up to implement quality control on pharmaceutical products. This is to ensure the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. Currently, efficacy testing is not required for herbal medicine as long as active ingredients satisfy the other two criterias. 

 

Published in 1999, the Malaysian Monograph Volume I features 20 local medicinal plant species in 16 aspects including the plant description, geographical distribution, chromatography, purity tests, chemical constituents and research on medicinal uses.  

There are three stages for the registration of health supplements.  

 

At Stage 1, a company fills in a letter of intent with particulars pertaining to the product. Following approval of Stage 1, product samples will go through laboratory analysis at Stage 2. They are tested for heavy metals contamination such as mercury (< 0.5="" ppm),="" arsenic=""><5 ppm)="" and="" lead=""><10 ppm).="" other="" quality="" control="" measures="" include="" microbial="" limit="" testing,="" disintegration="" testing="" for="" tablets="" and="" capsules.="" an="" adulteration="">

 

At Stage 3, a technical committee will evaluate documents pertaining to the product before it is registered. 

 

Manufacturers are encouraged to adhere Good Manufacturing Practice (GMP) from the quality of the raw material, to the premises to the manufacturing equipment and processes. Following compliance, the company is issued a manufacturer's license.  

 

To know if health supplements have been registered with the DCA, it should have registration numbers that start with PBKD or MAL printed on its label.  

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