New Dekhi: India's largest pharmaceutical company Ranbaxy Laboratories Limited expressed its disappointment over a decision by the US Food and Drug Administration to ban more than 30 of its generic drugs made at two of its factories at Dewas and Paonta Sahib.
The company issued a press statement on Wednesday morning and explained that always taken note of any concerns raised by FDA.
"Ranbaxy is very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs," the statement said.
Indian bureau chief of Phrama News Asia.com Vikas Dandekar said it would be difficult for Ranbaxy to get back in the clear.
"The problem is not with the existing drugs but the fact that FDA will not approve any new drugs made at the plants until the problems are resolved. It is culmination of two years of probe against Ranbaxy. Despite the criminal proceeding in Marryland Court FDA has stayed away from issuing any import alert. This will be quite a long issue for Ranbaxy to settle. After repeated questioning too FDA claimed that Ranbaxy's answer are not satisfactory," Dandekar said.
FDA's decision to ban more that 30 generic drugs would affect several widely used antibiotics, cholesterol medicines as well as AIDS medications.
Justifying its decision, FDA said the company failed to fix numerous problems with its manufacturing operations, record keeping and procedural issues.
FDA officials said the violations concerned the manufacturing process and not the drugs themselves, urging patients not to stop taking any medications and to talk to their doctors.
The move is also likely to affect a US programme of sending AIDS drugs to Africa, as Ranbaxy is a leading supplier.
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