Media Releases
Ranbaxy
18 September 2008
Medsafe and Pharmac acting on concerns over Ranbaxy medicines
The Ministry of Health's drug regulatory arm Medsafe is seeking renewed assurance of 'Good Manufacturing Practice' after an India based pharmaceutical company failed a US Food and Drug Administration audit at two sites early in the year.
Medsafe is seeking information from other trusted regulators (in Australia, Europe, Britain and Canada) to see if other audits can provide up-to-date assurance about 'Good Manufacturing Practice' at the two sites operated by Ranbaxy Laboratories Limited.
Ministry Chief Advisor Public Health Dr Ashley Bloomfield says Ranbaxy is a major contract manufacturer for both generic and innovative medicine companies. Its medicines are supplied to many parts of the world and Ranbaxy is frequently audited. It's quite possible that other audits will have given the two sites a clean bill of health.
The US FDA issued its warnings and import alerts for the two affected manufacturing sites early Wednesday (New Zealand time) based on its audits carried out much earlier in the year. The FDA's move is expected to apply pressure on Ranbaxy to respond more quickly to the FDA's concerns.
Dr Bloomfield says there is provision for an import ban under the Medicines Act. Medsafe has initiated the process that would enable a ban to be placed on further imports to New Zealand if the assurance being sought from other trusted regulators is not provided. If required, the import ban would be put in place before the next consignment of Ranbaxy stock is due to arrive in the country.
As an added assurance, Medsafe will initiate a targeted programme of product testing to confirm the quality and safety of the Ranbaxy medicines made at the affected sites. Similar tests carried out in the US have revealed no problems and US authorities are advising that Ranbaxy medicines already in the United States should continue to be used with only imports to be stopped at the border.
Dr Bloomfield says in both countries the advice to individuals taking these medicines is the same - there is no evidence that individual drugs have been affected and patients are advised they should continue taking them.
In the United States one drug produced at the two sites affected by the import ban has been exempted from the import alert as there is no readily available alternative in the US. This product is not distributed in New Zealand.
Medsafe and drug funding agency PHARMAC are working together to ensure minimum disruption to medicine availability - if tougher regulatory action is necessary. As a contingency measure, PHARMAC is now looking at alternative supply arrangements should this be required.
PHARMAC Medical Director Peter Moodie says we have at least 3 months supply of the medicines affected. He says it’s timely to start looking now for any alternatives even though we may never need them its better to be prepared now as alternatives may take some time to source.
Dr Bloomfield says we know that the FDA do not have safety concerns around any individual product, nor do they have any reports of adverse events linked to the manufacturing process of the drugs. He says other generic and innovator medicines, manufactured by the same company at other sites in India are unaffected.
However the FDA says they found a number of deficiencies during their audit of the company's 'Good Manufacturing Practice'; enough to warrant an import alert for products manufactured at the affected sites, but not sufficient to result in a recall of product in the United States.
Three branded medicine products manufactured at these Indian sites are both licensed and funded in New Zealand. They 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).
Dr Bloomfield says amoxicillin is very frequently used in New Zealand. He says it is important that the FDA measures are seen in context and that people are not unnecessarily concerned.
"There is no evidence that amoxicillin syrup, or the other drugs affected, are either unsafe or ineffective. All health professionals have been made aware of the situation and will be able to advise on options, if people have concerns."
Medsafe advises that anyone with concerns about these medicines should in the first instance call Healthline on 0800 611 116 or talk to their health professional.
Medsafe will be keeping in close contact with its Australian counterpart the Therapeutic Goods Administration and other regulators as well as keeping a close eye on any further regulatory action by the US FDA.
For more information contact:
Michael Flyger, Ministry of Health Communications Advisor 0274-346-878
Simon England, PHARMAC Communications Manager 021-863-342