New York/New Delhi: US Food and Drug
Administration (FDA) has said Ranbaxy is not taking adequate
corrective measures to meet regulatory requirements even after
receiving warning letters from it.
"It is apparent that Ranbaxy's attempts to make global
corrections after past regulatory actions by the FDA have been
inadequate," FDA said in a warning letter posted on its
website issued by it on December 21, 2009, to its US-based
subsidiary Ohm Laboratories for violating norms of current
good manufacturing practice (CGMP).
The letter mentions certain cGMP violation based on site
inspections conducted between July and August 2009,
It had also received two warning letters from the US FDA,
which subsequently banned import of 30 generic drugs produced
at two of its plants located at Dewas in Madhya Pradesh and
Paonta Sahib, in Himachal Pradesh.
Later, the US FDA also imposed an Application Integration
Policy (AIP) against the Paonta Sahib facility alleging
fraudulent practice and falsifying test reports. Under AIP,
application for approval of drugs manufactured at the
company's Paonta Sahib are not entertained by the US FDA.
The regulator in the warning letter has said, "We note
that the CGMP violations listed in this letter include similar
violations to those cited in the June 2006 and September 2008
Warning Letters issued to other Ranbaxy Laboratories
facilities."
Ranbaxy spokesperson declined to comment.
PTI
First Published: Thursday, February 04, 2010, 23:27