It turns out that an import alert from the U.K. has greater reach than one might suppose. The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) last week placed a ban on products from a Wockhardt plant in India because of manufacturing problems, the same plant from which the FDA is blocking products. This week, the MHRA clarified that the ban prevents the drugmaker from exporting from that plant to any country in the EU. It also said it was recalling 16 products as a precaution.
When the U.K. ban was first issued, Wockhardt disclosed it but did not indicate that it applied to all of Europe. But in an emailed statement to FiercePharmaManufacturing Wednesday, the MHRA said: "The statement of non-compliance with Good Manufacturing Practice (GMP) guidelines means that Wockhardt have been stopped manufacturing medicines for Europe."
The U.K. regulator said that an inspection of the plant in Waluj in Maharashtra in March found a number of problems including the potential for "cross-contamination." It also found "evidence of data falsification in relation to staff training records that were rewritten without authorization," the MHRA said.
The company told the Business Standard that the plant in question doesn't ship products to countries in the EU outside of the U.K. But it did make products there for the U.S., at least until May when the FDA issued an import alert for the solid-dose and sterile-injectables plant. Workhardt is working to get the issues resolved and could shift some production to other plants. But Wockhardt Chairman Habil Khorakiwala told the Indian press service PTI that the U.S. ban could cost the company $100 million in lost sales.
- read the Business Standard story
- here's the MHRA release