NEW DELHI (REUTERS) - During a visit to a facility of leading Indian drugmaker Ranbaxy Laboratories last year, inspectors from the United States found that a black fibre embedded in a tablet could have been a hair from an employee's arm, according to documents seen by Reuters.
That and other quality concerns led the US Food and Drug Administration (FDA) to impose an "import alert" on its Mohali plant last week, saying the factory owned by India's biggest drugmaker by sales had not ensured manufacturing quality.
Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo and gets more than 40 per cent of its sales from the US, did not immediately respond to a request on Wednesday for comment on the FDA observations.
The FDA's action has dealt another blow to an Indian generic drug industry battered by a rash of American regulatory rebukes and as US demand for generics grows, especially under President Barack Obama's new health-care programme. The import alert issued to Ranbaxy prohibits it from making FDA-regulated drugs at the Mohali facility and selling them in the US until its methods, facilities and controls are in compliance with good manufacturing standards.
The unexpected import ban on the Mohali facility sent shares in Ranbaxy plunging by one-third on Monday, and comes just a few months after it pleaded guilty to US felony charges related to drug safety and agreed to US$500 million (S$632 million) in fines. It brings under sanction all three of Ranbaxy's plants in India dedicated to supplying the US, and followed FDA inspections in September and December last year.
During one of the inspections, the FDA concluded that a black fibre embedded in a tablet was likely either "tape remnants on the nozzle head of the machine or a hair from an employee's arm that could be exposed on loading the machine", the documents showed.
Ranbaxy said on Tuesday it would review the details of the FDA import alert and take "all necessary steps to resolve the concerns" at the earliest.