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Voluntary quarantine of Ranbaxy drugs in place

Media release

25 September 2008

Voluntary quarantine of Ranbaxy drugs in place

New Zealand's reaction to the United States Food and Drug Administration import alert around three pharmaceuticals is in line with other regulators internationally. The alert, issued by the FDA last week, relates to products manufactured by Indian drug firm Ranbaxy Laboratories.

Medsafe has contacted other pharmaceutical regulators worldwide and while still waiting for further replies, it is clear that the United Kingdom, Germany, the Netherlands, Australia and Canada have not moved to restrict the availability of these products. The World Health Organisation has issued an advisory which details their actions, which are similar to moves underway in New Zealand. http://healthtech.who.int/pq/

Further information, including initial test results on the batches of the drugs already in New Zealand, is expected in about three weeks. The two suppliers of the three Ranbaxy funded products available in New Zealand, Douglas Pharmaceuticals Limited and Apotex New Zealand Limited have agreed to a voluntarily hold the products, which are due in the country in October. This means the products will be held in quarantine at the companies' own warehouses, and not released for distribution.

The focus on Ranbaxy's manufacturing processes arose when the United States imposed an import alert on medicines imported into the United States after FDA audits of two Ranbaxy sites in March this year. The auditors raised concerns over good manufacturing practices at the sites.

The voluntary quarantine of imported product in New Zealand will allow more time for testing of the products as well as allowing Medsafe to continue discussions with other international regulators.

Ministry Chief Advisor Public Health Dr Ashley Bloomfield says Medsafe has contacted regulators from the Netherlands, Germany, the United Kingdom, Canada and Australia. None are planning to restrict the availability of any of the listed products, through either an import ban or recall, advice which is consistent with and validates Medsafe's current approach. He says the voluntary action by local importers means a decision around a possible import ban can be deferred until the end of October, when more information will be available.

Dr Bloomfield says the advice to anyone concerned about the products remains the same. He says Medsafe's advice echoes that issued by the FDA and the WHO - there is no evidence that individual drugs have been affected and patients may jeopardise their health by stopping taking them.

The three products manufactured at these two Indian sites that are both licensed and funded in New Zealand are amoxicillin syrup (a widely prescribed penicillin-based antibiotic), aciclovir (an antiviral drug used to treat the herpes virus) and cefaclor (an antibiotic used to treat a wide range of infections).

Anyone with concerns about any of these products can call Healthline on 0800 611 116. A link to Medsafe's previous release, plus a series of questions and answers about the FDA action and the Ranbaxy products supplied in New Zealand, can be found here:

http://www.moh.govt.nz/moh.nsf/pagesmh/8391

Ranbaxy Laboratories Limited is a multinational drug manufacturer operating in 11 countries including the United States (where there are three plants). It has worldwide sales of $US1.6 billion. More information about Ranbaxy can be found on the company's website at www.ranbaxy.com

ENDS

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