This is with reference to a news item on Natco’s anti-cancer drug Albupax which appeared in a section of the press on 19th October 2009.


‘Natco’ wishes to clarify the position:

	We deny any legal action was initiated against our company.
	A complex topic like nano technology and the test methods are being debated in the press without providing any technical background and details. Our competitors are resorting to the insidious campaign through selective leaks and half-truths in the newspapers to malign our image and reputation. They are attempting to keep this issue alive so that all the generic competition is completely blocked.
	The press note mentioned of high levels of endotoxins in the drug. The test results on endotoxin levels are highly dependent on the test kit employed due to interference caused by the nano particulates and excipient proteins. The kit by M/S Charles River is employed by the Govt. analyst CDL, Kolkata and the results obtained by this kit are known to vary by as much as 2-to-4 fold according to manufacturer’s own manual.
	The same samples when analysed by a different kit (viz., the Lonza’s kit) yield different results all within the specified limits for endotoxins. These results are further confirmed by the National Accreditation Board for testing and calibration for Laboratories (NABL) accredited laboratory. We have obtained our license using this kit only.
	Natco has realized these test kit dependent results and is in the process of streamlining the test procedures to achieve foolproof results as a proactive measure.
	Natco has promptly recalled the available batches of Albupax from the market on the directive from DCGI.
	NATCO is officially complaining to the DCGI on this insidious campaign adopted by our competitor company.