Tuesday, October 6, 2009

Health warning on traditional medicine capsule - Star

Oct 6, 2009 By DHARMENDER SINGH

PUTRAJAYA: The Health Ministry has advised the public against buying and using Senna Plus Capsule 400mg after the Drug Control Authority (DCA) cancelled the registration of the traditional product.

The DCA said the capsule (labelled MAL06100616TC) contains a scheduled poison.

The ministry’s Pharmacy Services senior director Eisah Abdul Rahman said the DCA had cancelled the registration of the product following the detection of the scheduled poison Sibutramine, which is not allowed for use in traditional products.

The product registration holder for the Senna Plus Capsule 400mg is Winson Health Product Marketing and the manufacturer is TST Packaging Sdn Bhd, she said.

She said there were certain products containing Sibutramine that were registered with the DCA but these had been evaluated for their safety, efficacy and quality.

Furthermore, those products can only be supplied by doctors or obtained from pharmacies with a prescription.

“The public should not use traditional products containing the scheduled poison without consulting a doctor because its use without proper diagnosis and monitoring could cause serious adverse events such as high-blood pressure and other cardio-vascular effects.

“The products can have detrimental effects on consumers in the high-risk category,” she said in a statement issued Tuesday.

Eisah said the ministry was also calling on anyone possessing the product to immediately cease its sale, distribution or use.

She said possession for sale of the product was an offence under the Controlled Drugs and Cosmetics Regulations 1984, which carries a fine of up to RM25,000, three years’ jail or both for the first offence, and a fine of up to RM50,000, five years’ jail or both for subsequent offences.

Companies face a fine of up to RM50,000 for the first offence and a maximum fine of RM100,000 for subsequent offences, she said.

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