Traditional medicinal materials basically fall under two broad categories, mainly those sold in loose or bulk form, and those that are pre-packed for sales (stating information such as product name, brand name, ingredients, dosages and/or instructions for use on the packaging materials).
Presently, there is no licensing requirement for the import and local sale of traditional medicinal materials that are not of finished dosage forms (e.g. capsules, tablets, granules).
However, it is the responsibility of the dealers to ensure the safety and quality of the traditional medicinal materials that they deal with, including the following:
- The traditional medicinal materials do not contain any substances controlled under the Poisons Act and other prohibited substances such as Pangamic acid including its salts, Danthron, Suprofen including its salts and Rhodamine B.
- The heavy metal contents of the traditional medicinal materials do not exceed the following limits: Arsenic (5 ppm), Copper (150 ppm), Lead (20 ppm) and Mercury (0.5 ppm).
- The labels and packaging materials of the traditional medicinal materials (if any) do not stipulate any of the 19 diseases/conditions specified in the Schedule of the Medicines (Advertisement and Sale) Act, namely, blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy or fits, hypertension, insanity, kidney diseases, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotence, frigidity, conception and pregnancy.
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