Refusal of US FDA for export from Ranbaxys banned units
The head of US FDA has refused the petition of Ranbaxy Laboratories to permit the export of drugs from banned manufacturing unit while they get through the measures to rectify the issues raised.
In the meeting, Managing Director of Ranbaxy requested the head of US FDA for framing a policy which would allow drug manufacturers to continue doing business in the US so that they could generate the expenses for remedial measures. But US FDA states that they cannot change the laid-down rules to make such concessions and while companies were engaged in talks for one-off lapses, persistent mistakes were taken very seriously.
The US FDA has prohibited Ranbaxy from exporting drug products or medicines to US from three units in India because of manufacturing malpractices and earlier this year it also blocked the export of pharmaceutical ingredients from its plant at Toansa in Punjab for FDA regulated drug products.
Toansa is the key plant of Ranbaxy for manufacturing facilities of active pharmaceutical ingredients (API) and an alarm for ban has put further pressure on business atleast for now.