MHRA warns of more counterfeits in supply chain
EC figures show rise
There has been a significant increase in the
amount of counterfeit goods, particularly counterfeit medicines,
seized at the EU’s
external borders, figures
released last week by the European
Commission reveal.
Customs officials seized more than 250 million
counterfeits
in 2006 compared with 75 million in 2005. Counterfeit medicines
accounted for just over 1 per cent of the total: 2.7 million
up from 500,000 in 2005.
The number one source of counterfeit
medicines
in 2006 was India which, together with the United Arab Emirates
and China, accounted for over 80 per cent of counterfeit
medicines seized at EU borders. |
More counterfeit medicines have been discovered in the UK supply chain.
Last week, after The Journal went to press, counterfeit versions of AstraZeneca’s
Casodex (bicalutamide) tablets 50mg — imported into the UK through
parallel trade — were reported to the Medicines and Healthcare
products Regulatory Agency. And earlier this week a discovery of further
batches of counterfeit Plavix (clopidogrel) was flagged up by the MHRA.
A spokeswoman for the MHRA said that a wholesaler raised the alarm after
being offered the bicalutamide tablets — which it suspected to
be counterfeit — by another wholesaler.
Initial tests on samples show that the bicalutamide tablets contain about
75 per cent of the labelled active ingredient. The counterfeit product
is likely to bear a different bioavailability profile and may contain
harmful degradants, the MHRA said.
At the moment the MHRA is not aware of any patients having adverse reactions
as a result of taking the counterfeit medicines, the MHRA spokeswoman
confirmed. It is believed that none of the counterfeit clopidogrel has
reached patients, she added.
The most recent clopidogrel fakes were uncovered through the MHRA investigation
into counterfeit Zyprexa (olanzapine) that led to the discovery of the
first two batches of fake clopidogrel tablets (PJ, 2 June, p635 and p641).
The MHRA spokeswoman described the criminal investigation as “substantial” and
involving some 20 personnel.
The latest counterfeit clopidogrel was repackaged into English language
cartons by Waymade Healthcare, based in Essex. Brian McEwan, general
manager at Waymade, spoke to The Journal. He explained that when the
original alerts went out the company examined its stock and was happy
that it had not handled the affected batches.
In discussions with the MHRA, however, Waymade was alerted to the possibility
of other batches being counterfeit. Mr McEwan explained: “They
advised us that some Plavix we had bought might be affected. We sent
them samples for testing and, to err on the side of caution, instigated
our own recall [of the product sold].”
He said that Waymade had purchased the product in good faith and had
no suspicions then about its integrity.
AstraZeneca, maker of Casodex, plans
to implement tighter distribution arrangements, which are expected to come into place over the summer (PJ,
28 April, p475). A spokeswoman for the company commented: “AstraZeneca’s
recent revision of its supply chain delivery system will not only ensure
an efficient and effective supply and delivery service for all community
pharmacies, dispensing doctors and hospitals, but also will help reduce
the risk of counterfeit medicines reaching patients in the UK.”
BAPW questions volume of wholesaler licences
issued in UK
The recent increase in counterfeit medicines found in the UK
supply chain was discussed at the British Association of Pharmaceutical
Wholesalers conference in Marlow, Buckinghamshire, earlier this
week.
Martin Sawer, executive director of BAPW, said: “BAPW members are united
with manufacturers and regulators in ensuring that we share information and intelligence
to lessen the risk of this scandalous and dangerous trade.” He raised the
question of why there are currently over 1,700 wholesaler dealers’ licences
that have been issued by the Medicines and Healthcare products Regulatory Agency
in the UK. “Surely in the current climate this is an area in need of urgent
attention,” he said.
Lord Hunt of King’s Heath, health minister with responsibility for pharmacy,
commented on the problem: “Clearly the availability of counterfeit medicines
is extremely rare in terms of the number of reported cases in this country.” He
said that there cannot be any room for complacency and stressed the importance
of wholesalers working with the MHRA to tackle the problem. |
See also Notice-board p668 |
The
Pharmaceutical Journal
Acrobat
Reader