The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.
In 2010, several clopidogrel drugs made by Acino Pharma GmbH (now called Acino AG) were banned after an inspection at a plant operated by active pharmaceutical ingredient (API) supplier Glochem Industries in Visakhapatnam, India uncovered good manufacturing practices (GMP) violations.
At the time the European Medicines Agency (EMA) recommended that the Commission suspend authorisation for the products and ordered the withdrawal of batches that had already been shipped.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) also advised that the Visakhapatnam facility was removed from the list of plants authorised to supply the drug active.
Acino appealed this ruling arguing that the GMP breaches had no effect on quality and that European Medicines Agency (EMA) procedures indicate that “breach of the rules on good practice alone does not create a risk to health.”
No recall recommended
The German drugmaker also pointed out that the EC had ordered it to withdraw product even though the inspector who visited the site explicitly stated that a recall was not necessary as the observed GMP violations did not relate to product quality.
“The General Court rejected that [the inspector’s] consideration by stating incorrectly… that the Commission had, in any event, the power to adopt measures under Article 20(3) of Regulation No 726/2004.
“Those purely formal considerations are open to criticism since they fail to explain why the Commission rejected that inspector’s recommendation.”
Acino’s appeal with rejected by the Court of Justice of the European Court in April which countered - in a judgement published last month – that it is the EC that decides whether or not to ban a drug that falls short of GMP requirements not the inspector that visits the site.
The German drugmaker declined to comment when contacted by in-Pharmatechnologist.com.