Europe halts sale of Indian-sourced drug

European regulators have halted sales of several variants of clopidogrel, a drug widely used to stop blood clots, in a move that raises concerns about increased production of low-cost generic medicines from India. The European Medicines Agency said it had recalled batches of eight separate generic versions of the drug overseen by Acino Pharma, based in Germany, but with the raw ingredients made in India.


The recall will affect Acino, Sandoz, Hexal, and Ratiopharm. The action follows inspections by German regulators at the factory of Acino’s supplier Glochem Industries in Visakhapatnam in India, which concluded that it did not meet adequate “good manufacturing practice”. They however stressed that they had not identified any impurities in the clopidogrel and that its action was “precautionary”, with no consequences expected for patients. However, inspectors were not satisfied with the documentation drug manufacturers are required to maintain in order to prove that a standardised set of procedures are being followed to ensure safe and consistent production. The agency had concluded that “the processes used to manufacture the active substance … could not be trusted”. It said it “did not have sufficient confidence in the quality of the active substance, and this led to a lack of confidence in the quality of the medicines”.


FT