After the U.S. Food and Drug Administration's, or FDA, banned the import of all Ranbaxy (BOM: 500359) products made at its newest facility in northern India citing lapses in manufacturing practices, drug-control authorities from other countries such as Australia and UK, and Europe are examining products exported by the generic drugmaker for possible violations.
Government regulators have requested details from the FDA on the discrepancies detected in Ranbaxy’s plant in the northern Indian city of Mohali, Press Trust of India, or PTI, reported.
"The TGA (Therapeutic Goods Administration ) is in communication with the US FDA and is awaiting details to determine whether any Australian medicines may be affected by the FDA findings," a spokesperson told PTI. The spokesperson added that the TGA will decide on the required action against the generic major after examining the data provided by the FDA.
The UK's Medicines and Healthcare Products Regulatory Agency, or MHRA, also expressed similar views.
"We are currently working with the FDA and other European regulators to assess the impact the FDA's action has on the medicines from the Mohali site that are destined for the UK and European market,” MHRA told PTI. "There is currently no evidence that medicines on the UK and EU market manufactured at this site are defective so people should continue to take their medicines," MHRA added.
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FDA imposed an import ban on Sept. 13 on Ranbaxy's products made at its Mohali plant and the company’s stock lost about a third of its value on the following trading session. The FDA in a statement had cited serious lapses from the generic major’s plant “including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.”
The company has been battling several allegations of lapses at its manufacturing facilities in the past and had agreed to pay a fine of $500 million in May after it pleaded guilty to felony charges related to drug safety in the U.S. The FDA had imposed import alerts at Ranbaxy facilities, including at its Indian plants in Paonta Sahib and Dewas in 2008, and both facilities are still on the FDA import alert.
Ranbaxy is not the only Indian drug major found by the FDA to have violated its quality requirements. Last week. Bangalore-based Strides Arcolab (BOM:532531) received a warning letter from the FDA about quality lapses at its facility. Earlier in the year, Mumbai-based Wockhardt had also received a warning from the FDA about lax manufacturing standards at its local facilities.
Meanwhile, FDA has accused another Indian generic drug maker, Mumbai-based USV, of fudging data, the Economics Times reported on Monday.
The FDA said that its June inspection of USV’s testing laboratory in Mumbai showed that the company’s "drug product test method validation data is falsified,” the newspaper reported. The company is yet to receive a warning from the FDA, although the agency has communicated its observations, the report said.