Pfizer has issued another recall for packs of its blockbuster cholesterol drug Lipitor after UK regulators found evidence of more counterfeit product in the legitimate supply chain from a batch whose withdrawal was supposed to have been completed a year ago.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has reissued its safety warning after it was discovered that a recall in July 2005 of batch 004405K1 of Lipitor 20mg tablets had left some fake tablets with pharmacists.
These tablets contain lovastatin as an active ingredient as opposed to atorvastatin, though both statins have a similar effect of lowering cholesterol and the effect on patients is considered negligible.
Still this latest development is bound to reopen the debate about the responsibility of manufacturers in securing the integrity of the supply chain.
Because of the high cost of implementation as well as concerns about security, reliability and privacy, only few drugmakers have adopted sophisticated technology such as radiofrequency identification (RFID) and even then only for particularly commercially successful and vulnerable products, such as Viagra, and only in just some markets.
Although the MHRA has found only four cases of counterfeit drugs in the UK in the last ten years, such incidents are taken very seriously; last year Pfizer said it was forced into a mass recall of 120,000 packs of Lipitor as 73 packs of counterfeit drug seized - after already entering the supply chain - carried the same batch number as the genuine batch.
Parallel trade, whereby drugs are shipped around Europe to exploit price differences, also makes detecting counterfeits a major challenge.
"Our investigation is ongoing and is focused in the North of England, we don't know where the fake Lipitor came from but counterfeits in the UK usually come from India or redundant plants in the former USSR and China," MHRA spokeswoman Sara Coakley told In-PharmaTechnologist.com.
"It is most likely the supply chain was breached from the wholesalers to the pharmacists but we are looking into that."
With sales of Lipitor rising nine per cent to $3.1bn (€2.4bn) in the second quarter of 2006, the world's most popular prescription drug is particularly susceptible to counterfeiting but it is certainly not the only one targeted.
In 2004, counterfeit batches of Eli Lilly's Cialis, used to treat impotence, and Abbott's Reductil, used to treat obesity, were discovered in the UK.
The business of selling fake drugs is a burgeoning global industry, estimated to grow 13 per cent a year to reach $75bn in 2010, compared to just 7.5 per cent estimated annual growth for global pharmaceutical commerce, according to market research analysts Gartner and Frost & Sullivan.