India’s largest drug-maker Ranbaxy Laboratories Ltd has agreed to produce audit documents of one of its domestic manufacturing facility to the United States Department of Justice (DoJ).
Drugs major wants US regulator to detail its concerns on manufacturing practices at a domestic facility
NEW DELHI: India’s largest drug-maker Ranbaxy Laboratories Ltd has agreed to produce audit documents of one of its domestic manufacturing facility to the United States Department of Justice (DoJ) in response to a compelling motion filed by the US Food and Drug Administration (USFDA).
The company has also asked the US agency to share the details of its concerns on the manufacturing practices at the Paonta Sahib facility.
The USFDA, on July 3, had filed a compelling motion in a court of Maryland asking Ranbaxy to produce details and papers related to all the audits conducted at the facility.
The US pharma regulator had said Ranbaxy sold poor quality drugs in the American market and had concealed and forged data to comply with good manufacturing practices standards in that country.
“Ranbaxy is in the process of producing requested supporting documentation for its Abbreviated New Drug Applications (ANDAs) to DoJ and believes that the requested documentation will demonstrate that no data manipulation, fraud, or dishonesty occurred in those applications,” the Indian company said in a response filed in the court.
The company had earlier refused to produce the documents of the audits conducted by an independent agency Parexel appointed by it, citing attorney-client and work-product privileges as the reason.
“Ranbaxy has repeatedly requested the US government to share the details of its concerns, so it can help the government determine if any problems exist,” it said, adding, “The government has chosen not to share such information yet. This is consistent with the DoJ’s regular practice in investigations. If and when the government chooses to share the details of its concerns, Ranbaxy commits to responsibly respond to, and resolve, those concerns.”
The Indian drug company said that Parexel is likely to produce the documents within a month.
“Ranbaxy’s counsel has notified Parexel’s counsel that it has waived privilege for the audits and work papers. Parexel believes that it can produce the remaining documents within a month. The US government has agreed to withdraw the motion once the documents are produced,” the filing said.
The USFDA had, in its filing, accused Ranbaxy using client-attorney and work-product privileges as an excuse to hide the deep problems in good manufacturing practices standards within the company.
The Indian company, it said, waived the said privileges to produce select parts of documents after the USFDA initiated an investigation into its Paonta Sahib manufacturing plant and imposed a compliance hold on new drugs coming out of the plant.
The watchdog said that Ranbaxy released substantial information and actual portions of audits conducted thereafter in a bid to persuade the FDA to lift the hold.
“In the process, Ranbaxy waived any audits that might have been attached to the audits. Still, the company continues to assert privileges for some of the audit documents. These baseless assertions have significantly impeded the US government’s investigation,” the FDA had said.
a_shaleen@dnaindia.net
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