Ministry orders halt to sale of Pan products
By M K Anwar 

Brunei's Ministry of Health has instructed all distributors and retailers of pharmaceutical products in the country to withhold the sale of Pan Pharmaceutical products and recalled the affected products. The ministry also alerted the public on the recall of vitamins, minerals and herbal products conducted by its regulatory counterpart in Australia, the Therapeutic Goods Administration (TGA).

In TGA's quality audit of Pan Pharmaceuticals Limited of Sydney, Australia, it found serious manufacturing breaches at the company, which resulted in quality and safety concerns on the products it manufactures. The manufacturing breaches included substitution of ingredients, manipulation of test results and substandard manufacturing processes.

TGA has suspended the manufacturing licence held by Pan Pharmaceuticals Ltd for six months effective April 28, 2003. Pan Pharmaceuticals Ltd is Australia's largest contract manufacturer of complementary medicines such as herbal, vitamin, mineral and nutritional supplements. This company also manufactures some over the counter medicines including pain relievers (paracetamol & codeine) and cold and flu preparations.

The ministry said it is continuously working with relevant health authorities to further identify and confirm on the exportation of the recalled products manufactured by Pan Pharmaceuticals Ltd.

About 1,650 preparations of products that are for export only are manufactured by this company under different brand names.

Some of the brand names are available in Brunei. It includes 21st Century Product, Cosway (M) Sdn Bhd, Kordel, Nature's Own, Nature's Way, Nature's Farm, Nutralife and Vita Health Labs Pte Ltd.

The ministry said it will continue to provide updates to the public on the list of affected products available in Brunei once they are identified and confirmed. This exercise will continue until the ministry has confirmed all affected brand names and products in the local market.

TGA has also confirmed that Pan Pharmaceuticals' products subjected to recall affect only those manufactured after May 2002.

This is the latest date that TGA can assure that Pan Pharmaceuticals complies with the requirements of TGA's quality audits of the manufacturing process and facilities.

The ministry also assured the public that up to this time, no reports of serious adverse drug reactions associated with the recalled products have been received locally.

TGA has confirmed that there was no evidence of intentional adulteration of Pan Pharmaceuticals' products with potent western drugs that can cause serious side effects.

Consumers have been advised to check the labels of their health supplement products for information on the source and manufacturer of the products.

They have also been told not to consume those non-essential health products if the labels indicate that the manufacturer is Pan Pharmaceuticals Ltd of Sydney Australia or the brand names mentioned by the Ministry of Health until cleared otherwise.

Those who feel unwell and think that it may be associated with the consumption of the affected brands should contact healthcare professionals.

More information on the affected products can be found in the TGA web site www.health.gov.au/tga/recalls/panos.htm.

The public can also contact the Pharmacy Enforcement Section at the Department of Pharmaceutical Services for any queries (Tel & Fax: 2230036).

Courtesy of Borneo Bulletin