Further import ban on Ranbaxy drugs unlikely

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New Delhi, Sep 25: Ranbaxy is unlikely to face an import ban in regulated markets other than the US in the immediate future, if one goes by the New Zealand regulator Medsafe’s September 25 statement. There was a concern in regulated markets following US FDA’s ban on Ranbaxy drugs manufactured at two sites in Himachal Pradesh and Madhya Pradesh over delays in fixing alleged procedural irregularities in the manufacturing process.

The New Zealand ministry of health’s chief advisor, public health, Ashley Bloomfield said in the statement, “Medsafe has contacted regulators from the Netherlands, Germany, the UK, Canada and Australia.”

“None are planning to restrict the availability of any of the listed products through either an import ban or a recall, advice which is consistent with and validates Medsafe’s current approach”. It points out that discussions are still on with the other regulators.

The New Zealand drug regulator also said that the only two distributors of Ranbaxy medicines in the country have opted for voluntary quarantine of the shipment of three medicines manufactured at the two suspect sites—Dewas and Paonta Sahib—due October onwards. This means that they will not release the concerned medicines in the market; hence no immediate decision on ‘import alert’ is needed, according to Medsafe.

Meanwhile the regulator is getting the medicines independently tested; results are expected in the next three weeks.

The New Zealand ministry of health website maintains that Medsafe proposes to seek renewed assurance on good manufacturing practices of Ranbaxy. The three drugs in question 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).