Suspected human hair in tablet cited in US' Ranbaxy import ban
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.