On 25 March 2010, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the recall of all batches of eight centrally-authorised generic clopidogrel-containing medicines [1], due to GMP failure at the active substance manufacturer site. The firms concerned are Acino Pharma GmbH, Hexal AG, Ratiopharm Inc and Sandoz Pty Ltd.

While neither the regulatory authorities nor the marketing authorisation holder have received reports raising concerns about these medicines from patients, pharmacists or prescribers, the CHMP recommended in April 2010, as a precautionary measure, that all batches using clopidogrel made at the Glochem Visakhapatnam factory be recalled from the supply chain starting at the level of pharmacists. The Committee also recommended that the Glochem Visakhapatnam manufacturing site be removed from the list of sites allowed to supply clopidogrel to Acino Pharma GmbH for their generic medicines.

The generics industry argues that if sufficiently high profit margins were allowed, they could continue to manufacture in Europe. In the current economic climate, firms are being forced to relocate to India, next stop China.

The case for internationalisation was defended not long ago by Mr Johan van der Sluis – CEO of Focus Farma and importer of Ranbaxy products. When interviewed, he said he could deliver Western quality at Eastern prices.

Is this just an isolated incident? Is the generics industry putting profit before quality? Does Europe want to maintain the jobs and prestige of international drug manufacturing? Or is the concern to prevent healthcare spending getting further out of control paramount? Last but not least, is the EMA capable of policing a global supply chain? Only time will tell.

Reference

European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH. EMA. 25 March 2010.