Thursday, September 18, 2008

NY ex-Mayor to help banned Indian drugs maker

n a severe setback for Ranbaxy Laboratories, the US Food and Drug Administration (US FDA) has banned the entry in the US of over 30 medicines manufactured by the drug maker at two of its Indian facilities. The regulator has also decided not to grant any new approval to Ranbaxy to sell drugs in the US that are manufactured at its facilities in Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh).

The US drug regulator has issued warning letters to the drug major where it has cited cross-contamination problems at the Dewas facility and equipment validation and improper maintenance of inspection re-cords at its Paonta Sahib as reasons for its action against Ranbaxy.

“Because of the extent and nature of the violations, US FDA on Tuesday issued an Import Alert, under which US officials may detain at the US border, API and both sterile and non-sterile finished drug products manufactured at such Ranbaxy facilities and offered for import into the US,” said an US FDA statement.

Indian drug firm Ranbaxy has hired ex-New York City Mayor Rudolph Giuliani as an adviser, the company says.

Ranbaxy said Mr Giuliani's consulting and investment firm will advise it and look into compliance issues.