Media Releases
Federal Government to strengthen pharmaceutical laws
The Federal Parliamentary Secretary for Health, Trish Worth, has foreshadowed a further strengthening of laws to crack down on shonky manufacturing of medicines.
TW 13/2003
28 April 2003
Federal Government to strengthen pharmaceutical laws
The Federal Parliamentary Secretary for Health, Trish Worth, has foreshadowed a further strengthening of laws to crack down on shonky manufacturing of medicines.This follows an announcement today by Australia's medicines watchdog, the Therapeutic Goods Administration (TGA), to suspend the licence to manufacture of Pan Pharmaceuticals Ltd of Sydney and to recall 219 of the company's products.
A further recall of products manufactured by Pan Pharmaceuticals, but under other brand names, will occur in the near future.
Ms Worth 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.
"This suspension is based on safety and quality grounds and follows hot on the heels of a successful prosecution by the TGA last week in a Brisbane court of Curacel International Pty Ltd for manufacturing counterfeit medicines," Ms Worth said.
"Curacel was fined a total of $84,000 for manufacturing counterfeit medicines, carrying out unlicensed steps in the manufacture of medicines and manufacturing and supplying unapproved medicines.
"Curacel Company Director, Mr Karim Rouan Cham, was also fined $12,000 for his involvement in label swapping of over the counter preparations."
Ms Worth said today's crackdown on Pan Pharmaceuticals follows potentially life threatening concerns over one of the products Pan Pharmaceuticals manufactured under another brand name, Travacalm, which put people in hospital and made others very sick.
"The TGA then audited Pan Pharmaceuticals and found a litany of substandard quality and safety practices including substitution of ingredients, manipulation of test results and substandard manufacturing processes," Ms Worth said.
"While the TGA has been able to act on the evidence from its audits in the case of Pan Pharmaceuticals, I will move to amend the Act to ensure that those who potentially put lives at risk by bad manufacturing practices face the full weight of the law."
"Consumers should be reassured that the regulator, the TGA, is keeping a watchful eye on companies that manufacture medicines and medical devices to weed out substandard practices to protect the health and safety of the Australian public."
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/recalls/pan.htm or phone the toll-free number 1800 220 007 (hours 8am - 8pm seven days a week).
