The recent trading suspension imposed on Australia's largest contract manufacturer of alternative medicines and pharmaceuticals will have ramifications well beyond its own shores, according to a UK-based industry source.
Australia's medicines regulator, the Therapeutic Goods Administration (TGA), instigated the action against Sydney-based Pan Pharmaceuticals after a series of manufacturing breaches were discovered including falsifying test results, substituting ingredients and substandard manufacturing processes.
At least 4,000 products the company manufactured for Australian and overseas brands were recalled. Trading in Pan shares was suspended and the company's licence to trade has been revoked for six months. It is the largest medicinal recall in Australia's history.
At press time, Hong Kong, New Zealand and Singapore had issued recalls of their own, and jurisdictions around the world were expected to follow suit, as Pan had numerous export markets.
Margaret Peet, director of UK-based Whole Health Marketing Solutions and the former managing director of retailer GNC UK, said the fall-out from the scandal was likely to be severe. "It will have an effect here in Europe—that's for sure," she said. "Regulators can just point to this now and say 'look at what happened in Australia—the regulations need to be as tough as possible'. It's a wake-up call and it means you can't trust anyone. If I was using contract manufacturers, I'd be doing my own batch testing and I'd certainly be getting the proper paperwork in place."
Peet said legislation currently passing through the European Commission such as Directives relating to herbs and supplements could be affected by the revelations. "It will give the legislators and regulatory authorities all the ammunition they need to clamp down on herbal medicines in particular," she stated. "It may well be the final straw."
Similarly, Allan Crosthwaite, technical director of the Complementary Healthcare Council of Australia, called the news a 'devastating blow' for the industry. He said up to 40 per cent of the products in Australia's 750 health food stores were supplied by Pan and up to 5,000 jobs were in jeopardy.
The TGA's principal medical adviser, Dr John McEwen, cited five instances where Pan-released products contained materials that had not been tested for their safety and four cases where laboratory test results were manipulated to meet regulatory specifications. There were also four examples of test results of an export vitamin product being fabricated. On several occasions beef cartilage had been substituted for shark cartilage in a shark cartilage preparation.
Pan first came to the attention of the TGA in January when its travel sickness tablet Travacalm was recalled. More than 80 adverse reactions and 19 hospitalisations were recorded at the time and 27 of these individuals were pursuing legal action against Pan.
Pan board member Professor Ken Baxter told an Australian newspaper there were "serious issues and deficiencies" the company vowed to fix but said the company did not owe the public an apology. In a statement, Pan said it had been the victim of a "rogue laboratory analyst" who falsified test results for the Travacalm tablets.
See www.tga.health.gov.au/recalls/pan.htm for more information.