Some companies just don't learn. Four years after U.K. regulators issued a ban on products from a Rusan Pharma site in India, inspectors returned to see if the drugmaker had gotten its standards up to par. They found that nothing has changed, or at least not enough for the company to escape the manufacturing suspension imposed in 2012.
According to a report posted Monday by the European Medicines Agency, inspectors were in the Rusan tablet- and capsulemaking plant in Gujarat in January, the first time since a statement of noncompliance was issued in 2012. No products have been shipped, at least to the U.K., since then. Inspectors found "a widespread failure of the Quality Management System including core systems."
They said the company did not have protections to prevent cross-contamination of drugs. In addition, workers testing and analyzing products were untrained and the data was suspect anyway because the plant's data and labs systems were not sophisticated enough to adequately trace products or protect the security of data. The ban will affect at least 20 drugs, some in different dosage forms, including diazepam, verapamil, metformin and amoxicillin.
Any number of Indian drug manufacturing sites, some operated by the country's largest drugmakers, have been banned from shipping products to the U.S., Europe and other markets for similar problems. Just last week, the EMA posted a ban of Indian Anuh Pharma after French inspectors documented two dozen deficiencies at the plant and found overall quality lacking. France's regulator recommended recalling from Europe all of the antibiotic APIs the plant manufactures because their original sources were unknown.
- here's the EMA report