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Health Industry

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Health Industry
#70
<b>U.S. Seeks Audits of Ranbaxy Generic Drug Plant in India</b> <!--QuoteBegin-->QUOTE<!--QuoteEBegin-->July 13 (Bloomberg) -- The U.S. is seeking a court order to force Ranbaxy Laboratories Ltd. to turn over an audit that it says will prove the Indian generic drugmaker distributed ``adulterated and misbranded products,'' according to court papers filed in U.S. District Court in Maryland.

The company has refused to turn over Parexel Consulting's report, claiming the information is protected by attorney-client and work-product privileges, according to the motion to force the company and the consulting firm to comply with the U.S. subpoenas.

<b>The U.S. alleged Ranbaxy used ingredients from unapproved sources and blended approved and unapproved substances, sometimes using less of the active drug than was mandated by the Food and Drug Administration, the court papers said</b>.

``Any of these conditions would cause a drug to be subpotent, superpotent or adulterated,'' the government said in its July 3 filing to force the company and its consulting firm to comply with the subpoenas.

The government also is probing whether Ranbaxy destroyed reports it was required to keep, falsified data and failed to meet quality control specifications in the manufacture of the ingredients, as well as the finished products, the court papers said.

`<b>Significant Violations' </b>

Since Ranbaxy already has released portions of the audit, the government said the document is no longer privileged, the court papers said. The audit followed the <b>FDA's letter in 2006 that there were ``significant violations'' at the company's Paonta Sahib, India, plant.</b>

The FDA put a hold on Ranbaxy's applications for new drugs from that plant, the government said. As Ranbaxy attempted to get the hold lifted, it released parts of the audit, which, according to the court papers, caused the company to waive any privilege attached to Parexel's report.

``Still, the company continues to assert privilege as to some of the audit documents, and these baseless privilege assertions have significantly impeded the government's investigation,'' the court papers said.

Ranbaxy spokesman Krishnan Ramalingam in Gurgaon, India, didn't immediately return calls and messages today seeking comment on the court documents.
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I am not surprised, India and China are horrible in ethics and quality. I hope they should lose business and slapped with heavy penalities.
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