The U.K.’s Medicines and Healthcare Products Agency (MHRA) has ordered India’s Akums Drugs and Pharmaceuticals to recall four batches of progesterone produced at its Hardiwar facility due to critical deficiencies uncovered during an April inspection.
In a notice posted on the Eudra GMP website, the U.K. regulatory agency said its inspectors found three major deficiencies, including a critical deficiency of “sterility assurance” as well as problems “across all aspects of the quality management system and lack of a robust environmental monitoring” program. An additional 13 issues were found but not formally recorded so the critical problems could be addressed on a priority basis.
The agency recommend four batches of Gestone (progesterone in 50 milligram injection ampoules) and supplied to the U.K and Ireland be recalled. The agency also put on hold a variation request to add Akums as a manufacturing site.
The MRHA added that since “this was the first inspection of the site… no manufacturing authorization has been issued.”
The facility was being positioned to supply progesterone for Nordic Pharma. According to information cited by in-Pharma Technologist, Nordic’s Gestone lists Sweden-based CMO Recipharm and U.K.-based SCM Pharma as suppliers.
Like the U.S., Europe gets much of its API production from India and monitors the industry there very closely. The European Medicines Agency has taken actions against half a dozen Indian manufacturers since the first of the year, but has also taken steps against plants in China, Spain, France and even in the U.S.
- find the Eudra GMP non-compliance report here
EMA bans APIs from two Indian manufacturers