Drugmaker Heel hit by massive counterfeiting case in Ukraine

Heel Traumeel packagingThe head of the Ukraine distributor representing German homoeopathic medicine firm Heel has been jailed for offenses related to medicines counterfeiting, according to the state regulatory authority.

The State Administration of Ukraine on Medical Products (SAUMP) reports that the executive director of Cascade Medical - the exclusive supplier of Germany-based Heel's products in the country - was sentenced to four years in prison last month.

The authorities have also confiscated "counterfeit medicines, raw materials and equipment for their production", according to the agency.

An unscheduled inspection by the SAUMP of Cascade Medical's premises in Kiev found 3.9m packages of counterfeit and unlicensed worth around 300m Ukrainian Hryvna (around $37m).

Packaged and unpackaged medicines were intercepted - labelled in both Ukrainian and German - without batch numbers, expiration dates or instructions, some of which were injectables that could place consumers at serious risk of harm. The SAUMP also found production equipment.

In May, Ukraine imposed a marketing suspension on all 68 Heel products sold in Ukraine "on suspicion of falsification", including brands - such as Traumeel, Zell T, Tserebrum Compositum, Discus Compositum and Viburkol suppositories - which featured among the top 20 medicines sold to the public in Ukraine last year.

Commenting on the situation, Heel's chief executive Ralph Schmidt said the company was "undertaking all efforts to have the temporary suspension lifted in cooperation with the authorities."

He said the company manufactures medicines in Germany that comply with Good Manufacturing Practice (GMP) and are subject to validation, monitoring and documentation by its quality control department.

"Providing safe medications ti patients is our absolute priority," added Schmidt. "We are confident to resume providing Ukrainian patients with high quality Hell medications soon."

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