After the UK drug regulator, the Australian drug regulator has also said that the drugs marketed by Ranbaxy Labs are safe.
“At present, there is no evidence that any of the products in the Australian market manufactured by Ranbaxy are of an unacceptable quality or that there is a danger to consumers in Australia,” a spokesperson for the Australian Therapeutic Goods Administration (TGA) told ET.
The Australian Therapeutic Goods Administration is aware of the criminal settlement involving Ranbaxy, said the spokesperson about the company’s settlement in US with department of Justice where it pleaded guilty and agreed to pay $500 million penalty.
The spokesperson further said that the Australian drug regulator was part of a multilateral inspection team involving the World Health Organisation and inspectors from the United Kingdom, Ireland, Germany, Canada and Singapore in 2008 to investigate these matters.
“The conclusion at the time was that there was no cause for concern for products in those markets,” he added. Besides, the TGA also independently tested samples of Ranbaxy products and found nothing to suggest unacceptable quality or a danger to consumers.
On Tuesday, Ranbaxy stock rallied 6.5% after reports that the US Food and Drug Administration said there was no evidence of major current good manufacturing practices (cGMP) violations except at the company’s Gloversville facility in the US.
The company has already closed down the Gloversville facility.
Last week, on Monday, the company’s share price had dropped by 7% after reports that Ranbaxy’s newly-commissioned facility at Mohali plant is under US FDA scanner for cGMP deviations.
The UK drug regulator Medicines and Healthcare products Regulatory Agency (MHRA) has recently said that it’s reviewing the Ranbaxy Labs regulatory issues in the light of recent revelation to see whether the situation warrants any future action. The drug regulator is currently in discussion with the US Food and Drug Administration, other EU and global regulators for the same.
In the same statement, the British regulator acknowledged that despite several focused inspections in collaboration with multiple drug regulators since 2006, it has found that the company complied in general with EU good manufacturing practice (GMP). It also added that ‘no evidence that any of the products on the UK market manufactured by Ranbaxy are or have been of unacceptable quality’.
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