Monday 28 April 2003

The Commonwealth medicines watchdog, the Therapeutic Goods Administration (TGA), has suspended the licence held by Pan Pharmaceuticals Limited of Sydney to manufacture medicines after TGA inspectors found a series of serious safety and quality breaches by the company.

These included substitution of ingredients, manipulation of test results and substandard manufacturing processes.

In addition the regulator has ordered an urgent recall of 219 products which Pan Pharmaceuticals manufactures and supplies in Australia, with a potential for a larger recall within days.

It is stressed that, up to this time, no safety problems have been identified with prescription medicines supplied as Pharmaceutical Benefits Scheme items. These medicines have been assessed thoroughly by the TGA and all people may continue to take their Pharmaceutical Benefits medicines without concern.

Pan Pharmaceuticals is Australia's largest contract manufacturer of complementary medicines such as herbal, vitamin, mineral and nutritional supplements. They also manufacture some over-the-counter (OTC) medicines including pain relievers (paracetamol & codeine) and cold and flu preparations (antihistamine & pseudoephedrine).

Other companies also use Pan Pharmaceuticals to manufacture their own brand products and the TGA will be working with these companies to identify which other products should be subject to recall.

The action by the TGA today follows advice received from an expert advisory group convened to give an independent evaluation of the TGA findings.

The group, chaired by Dr Richard Whiting, Chairman of the Medicines Evaluation Committee, reviewed the audit reports and advised that the quality and safety concerns posed by the manufacturing breaches at Pan Pharmaceuticals needed to be urgently addressed.

Acting on that advice the TGA has suspended the company's licence with an immediate effect to protect the health and safety of the Australian community.

This is not the first action taken against Pan Pharmaceuticals. In January this year an anti-travel sickness tablet, Travacalm manufactured by Pan Pharmaceuticals for another company, was the subject of a consumer recall.

Faulty batches of the tablets were responsible for 19 people being hospitalised and 68 others experiencing potentially life threatening adverse reactions to this over-the-counter medicine.

Subsequent laboratory testing by the TGA of some of the tablets revealed that one of the active ingredients - hyoscine hydrobromide - varied in content from 0 - 700% of the listed dose.

The company's manufacturing licence was immediately restricted to prevent the manufacture of Travacalm tablets and similar microdose products.

The TGA undertook further audits of the company which also revealed serious deficiencies in the company's manufacturing and quality control procedures, including systematic and deliberate manipulation of quality control test data.

The TGA's Principal Medical Adviser, Dr John McEwen, said the TGA has a responsibility to protect the health of all Australians and, as the regulator of medicines, is obligated to take action where there is a concern that consumers might be at risk because of sub-standard products.

"Manufacturers of medicines must comply with strict standards, so that consumers can be confident of the quality and safety of the medicines they take," he said.

Some examples identified by the audit included:

• On 13 March 2003 the status of 270 raw materials was changed in the company's computer from Quarantine to Pass. In a random sample of these, none had been tested. It has been clearly identified that some were used in manufacture but not tested by the time of the audit on 14 April 2003. For example, 7 of these raw materials were used in the manufacture of 34 batches of products.
• Four recent examples of manipulation of the assay results of finished products in order to comply with specifications. These occurred between October 2002 and 22 January 2003 and involved an "energy" product, a vitamin product and a cough and cold formula.
• Four recent examples of the fabrication of finished product assay results of a vitamin product for export in order to comply with specifications. In two instances the product was over-strength (March 2003); in the other two under-strength.
• In the past two and a half years, several instances of the use of beef cartilage in place of shark cartilage and one instance of use of shark cartilage in place of beef cartilage.
• Five instances where products were released and dispatched in the period 24 March 2003 to 31 March 2003 without completion of the testing of the raw materials used.

Further information about the products being recalled and products that may be manufactured by Pan Pharmaceuticals Ltd under other brands, visit the TGA website on www.tga.health.gov.au or phone the toll-free number 1800 220 007 (hours 8am - 8pm seven days a week).