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Update – February 26, 2009
FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib
Plant in India
The following company from India has caused the FDA to resort to a
not commonly used response to get companies to address problems of
integrity. The FDA used their Application Integrity Policy (AIP) when
they felt a company falsified their data to the FDA. This is a very
serious situation and not imposed on companies too often if at all. The
reason it is not used too often in the USA is because this could lead to
criminal investigations and prosecution. For foreign companies the
falsification of data leads to the possible withdrawal of the company’s
applications and the automatic detention of all products involved in the
applications. Criminal action is not an option for foreign officials.
The following was taken from the FDA website.
FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib
Plant in India
Agency halts review of drug applications from plant due to evidence
of falsified data; invokes Application Integrity Policy
The U.S. Food and Drug Administration today announced that a facility
owned by India-based Ranbaxy Laboratories falsified data and test
results in approved and pending drug applications. The facility, Paonta
Sahib, has been under an FDA Import Alert since September 2008.
The FDA is continuing to investigate this matter to ensure the safety
and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib
site. To date, the FDA has no evidence that these drugs do not meet
their quality specifications and has not identified any health risks
associated with currently marketed Ranbaxy products.
In the meantime, the FDA recommends that patients not disrupt their drug
therapy because this could jeopardize their health. Individuals who are
concerned about their medications should talk with their health care
professional.
The affected applications are for drugs that fall into three categories:
• Approved drugs made at the Paonta Sahib site for the U.S. market;
• Drugs pending approval at the FDA that are not yet marketed; and
• Certain drugs manufactured in the United States that relied on data
from the Paonta Sahib facility.
“Companies must provide truthful and accurate information in their
marketing applications,” said Janet Woodcock, M.D., director of the
FDA’s Center for Drug Evaluation and Research (CDER). “The American
public expects and deserves no less.”
To address the falsified data, the FDA has invoked its Application
Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is
invoked when a company’s actions raise significant questions about the
integrity of data in drug applications. This AIP covers applications
that rely on data generated by the Paonta Sahib facility only.
Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency to
resolve the questions of data integrity and reliability. This would
include implementing a Corrective Action Operating Plan (CAOP) to
provide assurance of the integrity and reliability of data from the
Paonta Sahib facility. A CAOP includes, but is not limited to,
conducting a third-party independent audit of applications associated
with Paonta Sahib.
When the AIP is implemented, the FDA stops all substantive scientific
review of any new or pending drug approval applications that contain
data generated by the Paonta Sahib facility.
“The FDA’s investigations revealed a pattern of questionable data
raising significant questions regarding the reliability of certain
applications, and this warrants applying the Application Integrity
Policy,” said Deborah Autor, director of CDER’s Office of Compliance.
“Today’s action reflects the FDA’s continued vigilance and its steadfast
commitment to safeguarding the public’s health.”
On Sept. 16, 2008, the FDA issued two warning letters and instituted an
Import Alert barring the entry of all finished drug products and active
pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and
Batamandi Unit facilities due to violations of U.S. current Good
Manufacturing Practices requirements. That action barred the commercial
importation of 30 different generic drugs into the United States and
remains in effect.
This puts a black eye on all Indian drug companies since Ranbaxy was one
of the largest drug companies in India. It also puts doubt on all other
foreign company’s applications.
If you would like to discuss this further, please email mdi at
info@mdiconsultants.com
and reference Ranbaxy.
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