Health authorities are to continue to make available a popular children's medicine made in India, despite a ban on its importation by the United States.
Yesterday, the United States Food and Drug Administration (FDA) banned generic drugs made at two sites of Indian company Ranbaxy, after it failed a good manufacturing practice audit in March.
The Ministry of Health and government drug buying agency Pharmac announced at a press conference this afternoon they were now considering whether to ban the drugs here.
The affected drugs are penicillin-based antibiotic amoxicillin syrup, herpes medication aciclovir and cefaclor, an antibiotic.
Ministry chief advisor public health Ashley Bloomfield said Ranbaxy was a major contract manufacturer for generic medications and its medicines were supplied to many parts of the world.
The FDA audit was in regard to the company's reporting and record-keeping practices, Dr Bloomfield said.
The FDA banned importation of the Ranbaxy's products from the two sites as the company had not made sufficient reassurances that they had come up to standard.
Tests had so far shown none of the products had been affected by the paperwork problems and patients were advised to continue taking the drugs, Dr Bloomfield said.
A lack of appropriate record keeping and auditing may have created a situation where cross-contamination could have occurred, but none of the testing had shown any evidence of it.
In order to ensure safety in New Zealand, however, Dr Bloomfield said tests were about to begin on the Ranbaxy products that were already in the country.
"And therefore our testing can look specifically to see whether that is an issue here.
"But our advice is very clear and that is people should continue to take their medication as it has been prescribed." Pharmac medical director Peter Moodie said the next date the drugs were to be imported into New Zealand was early October.
Pharmac and the ministry's drug regulatory arm Medsafe hoped to make a decision within the next few days on whether they would accept the import or not.
They were already sourcing other companies who could take over delivering the drug, he said.
Their decision on whether to allow Ranbaxy's drugs in relied on whether audits from countries such as Australia, Canada and Britain gave the company the all clear.
"To get alternative supplies is something that just doesn't happen overnight, but we will be looking at that with all due speed," Dr Moodie said.
If people who had been prescribed the drugs had any concerns, Dr Bloomfield advised they call Healthline on 0800 611 116, or speak with their doctor.
New Zealand has 12 drugs that come from either of the two affected Ranbaxy sites, but only three are funded by Pharmac and therefore frequently prescribed.
They are the anti-viral lovir (aciclovir) 200mg, 400mg and 800mg tablets, for which around 60,000 prescriptions are written a year; anti-bacterial cefaclor 250mg capsules and 125mg/5ml suspension (around 160,000 prescriptions a year); and anti-bacterial amoxicillin 125mg/5 ml and 250mg/5 ml suspension (around 400,000 prescriptions a year).
