FDA Suspends New Applications Approval from Indian Pharmaceutical Factory
Key Takeaways:
- American health authorities have suspended the processing of new drug applications from an Indian-based pharmaceutical plant owned by Ranbaxy Laboratories.
- The decision follows the discovery that the plant was submitting falsified scientific data in its FDA approval applications.
- The manipulation of data, considered a serious violation, is the second instance to have occurred at the Paonta Sahib facility in less than six months.
- The FDA will continue to halt reviews of drug applications from this plant until all issues are resolved and the accuracy of submitted information can be assured.
- No reports of harm from the use of Ranbaxy products made in the US or at the Paonta Sahib plant have been received, according to Dr. Throckmorton from the FDA. Patients are advised not to discontinue any medication without consulting their doctors.
The American health authorities have put on hold the processing of any novel drug applications from an Indian-based pharmaceutical plant owned by Ranbaxy Laboratories. This decision came after it was discovered that the facility was generating falsified scientific records.
Ranbaxy, an Indian entity, is among the primary sources of generic drugs for the United States. “Action was taken after it was made clear that the plant was presenting incorrect scientific data in its bid for FDA approval of drugs intended for the US market,” stated Dr. Douglas Throckmorton, the deputy director of FDA’s Center for Drug Evaluation and Research, during a teleconference on Wednesday.
Falsification of Data and its Impact
According to Dr. Throckmorton, Such a manipulation of data in drug applications is seen to be a “grave violation of integrity—a violation that should be promptly dealt with and rectified.”
He went on to add that this is the second time action has been taken against the Paonta Sahib facility in less than half a year, but affirmed that no other Ranbaxy facilities are directly affected by this proceeding.
Until all issues are addressed, the FDA will discontinue reviewing drug applications from this facility and won’t accept any new ones from the plant.
Categories of Applications Affected
The applications in question span three categories:
– Drugs for the U.S. market which were produced in the plant,
– Drugs not yet marketed in the U.S. pending FDA approval,
– Drugs manufactured in the U.S. that depend on data from the Paonta Sahib facility.
Back in September, the FDA revoked U.S. entry permission for 30 generic drugs produced in the Paonta Sahib factory and another branch facility in Dewas, India, due to concerns surrounding the manufacturing process. At that time, FDA officials even suggested denying any fresh drug applications emanating from these two plants.
Manipulated Data and its Implications
Detailed by Deborah Autor, Director of the FDA’s Office of Compliance at the CDER during the teleconference, some of the forged data from the Paonta Sahib plant is related to the products’ shelf life. Additionally, the company also manipulated data about production methods.
The approval of applications will only start again once Ranbaxy can prove to the necessary authorities that all of its information is accurate and the FDA does not harbor any reservations about the application data, Autor further clarified.
Most products created by the company in the United States are not part of the FDA action, Autor stated. However, there are a few U.S. products that are impacted. These include two cholesterol-lowering drugs, pravastatin (Pravachol) and simvastatin (Zocor), and an antihistamine known as pheniramine (Avil).
The FDA is requesting that Ranbaxy provide assurance that none of the data for these drug applications originates from the Poanta Sahib facility.
Dr. Throckmorton deems it important to stress that the FDA has received no reports of harm as a result of Ranbaxy products made in the U.S. or at the Paonta Sahib plant. Furthermore, the agency is advising patients not to cease any medication consumption without first discussing it with their doctors.
More Information
For further details on drug safety, you can visit the U.S. Food and Drug Administration website.
