Indian API faults prompt clopidogrel recalls in EU

The European Medicines Agency (EMA) has recommended a recall of batches of generic clopidogrel made by Swiss drugmaker Acino because of quality concerns about the active pharmaceutical ingredient (API) used in the products.

EMA's Committee for Medicinal Products for Human Use (CHMP) said the API manufacturing problems applied to API used in eight products sold in the European Union by Acino and under license by other generic drugmakers such as Sandoz, Ratiopharm and Hexal.

As the clopidogrel API was made by Indian company Glochem Industries at its factory in Visakhapatnam, the case raises questions about the increasingly prominent trend among the pharmaceutical industry of sourcing raw materials from countries such as India and China.

The globalisation of ingredient supply is driving the industry to work harder on implementing business processes and practices to minimise risk in the supply chain.

One example is the recent publication by a European industry body - the Active Pharmaceutical Ingredients Council (APIC) - of a quality agreement template which advises drugmakers on what to look for when selecting suppliers. Similar work has been undertaken by the International Pharmaceutical Excipients Council (IPEC), focussing on inactive ingredients, and the recently-formed Rx-360 consortium.

In the latest case, an inspection of the plant by the German regulatory authorities revealed a number of deviations from Good Manufacturing Practice (GMP) at the Glochem plant.

The EMA said it had asked for a recall "starting at the level of pharmacists," and has also recommended that the Glochem Visakhapatnam manufacturing site be removed from the list of sites allowed to supply clopidogrel to Acino.

Clopidogrel, originally developed by Sanofi-Aventis and Bristol-Myers Squibb which sell the drug as Plavix and Iscover, is used to treat patients who have had blood clots such as heart attacks or strokes.  The original branded product - which is the world's second biggest-selling drug with sales of $9 billion in 2009 - is not affected by the recall.

The EMA said the recall has been recommended as a "precautionary measure," adding that there have been no complaints about the medicines from patients, prescribers or pharmacists. Patients can continue taking the products, it said.

Acino, which acts as the Marketing Authorisation Holder for all the affected products, says it has now switched to another clopidogrel supplier, and future supplies are expected to meet the required quality standards.

Clopidogrel is its biggest product, accounting for around a quarter of total company sales.

In a statement, the company said: "should individual country authorities ... request a recall of the clopidogrel products concerned based on the CHMP or EU commission decision, the temporary supply shortage and the possible write-down of existing and returned goods could result in a negative extraordinary item in the current financial year."

"This would in all likelihood have a significant negative impact on the annual result 2010," it added.



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