Beximco Pharma’s glaucoma eye drops barred in Europe

Beximco Pharmaceuticals Ltd has been prohibited from supplying its timolol and latanoprost-branded eye drops used in glaucoma treatment in the European Union and the European Economic Area (EEA) owing to design concerns at its ophthalmic manufacturing unit, according to a news report.

As a result, the facility's Good Manufacturing Practice (GMP) certificate, issued in January 2020, will be withdrawn, said the article of Endpoints News, in which UK's Financial Times holds a majority stake.

The Malta Medicines Authority (MMA) found one critical, three major, and 15 other deficiencies while conducting an inspection between July 28 and August 1.

The critical deficiency relates to facility design. The building's management system was not working properly and environmental conditions could not be monitored.

Alarms were also not triggered if temperature, humidity and delta pressure alert levels were exceeded. The recovery was also slow following power failure.

The three major deficiencies relate to GMP activities, particularly aseptic processes, quality management and data integrity.

Beximco manufactures and exports generic medicines across different therapeutic categories, such as respiratory and cardiovascular diseases.

The company initially started its manufacturing capabilities through a licencing agreement with Bayer to produce and sell its products in Bangladesh. Beximco launched its own products a few years later.

In a clarification, Beximco said the critical deficiency finding relates to the unit's Building Management System (BMS).

It said Beximco does not currently export ophthalmic products from the unit to the EU or to the EEA.

"While the MMA has proposed that the EU prohibit the company from exporting these products to the EU or the EEA, this proposal has not yet been ratified by the EU."

The pharmaceuticals company continues to supply the products to other markets where approvals have been received, the clarification said.

In the absence of integrated and automated centralised monitoring by a BMS, the company is using alternative means to monitor the facility's environmental data, it said.

Beximco Pharma is working closely with the MMA to implement remedies to all of the observations cited in the report in a timely manner, including the installation of a new BMS, ahead of another audit by the MMA expected in early 2024, Beximco added.

The clarification also said the inspection findings are not pertinent to other manufacturing units of the company. "And the cost of implementing the remedies will not have a material financial impact on the company's performance for the current financial year."

The EEA includes 27 EU countries and Iceland, Liechtenstein and Norway.