When any member of the European Union finds issue with a drugmaker, it is reported to a central database to alert other members that might also buy from that facility. Now Slovenia has raised red flags about an Indian drugmaker it says it discovered during an inspection is not meeting cGMP standards.
Slovenian regulators told the European Medicines Agency that it pulled the certificate of suitability for the Polydrug Laboratories site in Maharashtra, India, after finding 17 deficiencies, 5 of which Slovenian regulators considered major. The action includes all of the active pharmaceutical ingredients (APIs) made at three plants, which include chlorobutanol hemihydrate, metoprolol tartrate, ferrous fumarate, fluconazole and others.
The inspectors said the drugmaker was "deliberately" not documenting customer complaints. They found problems with cross-contamination and said there were contamination issues with the anesthetic chlorobutanol hemihydrate. It also found that records were not sufficiently protected.
Like the FDA, regulators in Europe have found problems with API manufacturing at some Indian drugmakers. In January, the U.K. stiffened the action to include all APIs from a Wockhardt plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S. But also like the FDA, European regulators have had issues with plants in their home countries, as well as other countries. In March, French regulators reported issues at Huzhou Sunflower Pharmaceutical plant in Huzhou, Zhejiang Province, where it made iodine.
- access the report here