1. www.pipaonline.org Issue 10 • February 2007Page 6
The Illegal Sale Of POMs And
Unlicensed Medicines
By: Ray Bouch, Senior Trading Standards Officer, Lambeth Trading
Standards, London
Summary
Many metropolitan areas of the UK, including the London Borough of Lambeth, have
a number of retail shops that are involved in the supply of medicines illegally to the
general public.These illegal items for sale contain banned substances, unlicensed
drugs and/or undisclosed POMs (Prescription Only Medicines) such as corticosteroids
masquerading as natural, herbal or traditional Chinese medicines, for example.
This article will attempt to demonstrate what local Trading Standards departments and
the UK regulatory authority (Medicines and Healthcare products Regulatory Agency
– the MHRA) are actively involved in regarding the detection and prevention of this
illegal trade.
Introduction
Working in the London Borough of
Lambeth, it is apparent that there is a
considerable trade in the importation
and sale of unlicensed creams containing
corticosteroids (both declared and
undeclared) and cosmetics containing
hydroquinone. This is especially prevalent
in the area of Brixton although is not
unique to London.
There is a high demand for these products
because of their alleged beneficial effects
in conditions such as eczema, particularly
in children, and psoriasis. A cream known
as ‘Wau Wa’, for example, has been sold
widely for use in children suffering from
a multitude of skin complaints. Parents
from diverse ethnic groups favour this
cream, after prescribed conventional
western medicines are perceived to fail
to cure the problem, unaware that the so
called ‘natural’ remedy contains a potent
corticosteroid.
‘Wau Wa’ cream is misleadingly labelled
as a herbal remedy even though it may or
may not contain an extract of ‘Wau Wa’
root. Ironically, the ‘Wau Wa’ tree, a native
of Ghana, actually causes severe dermatitis
in timber workers who come into contact
with it and no therapeutic use has been
proven.
Importation
Both illegal medicines and cosmetics are
being imported into the United Kingdom
by various means, such as in the hand
luggage of international travellers or
hidden within airfreight packages.
Whilst some of the items are intercepted
at major transit points such as
international airports, others are smuggled
into the UK and are sold to retail outlets
that then supply them to customers.
The Illegal Medicines
Corticosteroid Prescription Only
Medicines. There are many corticosteroid
agents available that can only be
prescribed by a doctor. Unfortunately,
Both illegal
medicines
and
cosmetics
are being
imported into
the United
Kingdom
by various
means …
Ray Bouch

2. www.pipaonline.orgIssue 10 • February 2007 Page 7
some of these agents are diverted from
legitimate supply chains for sale ‘under’ the
counter in ‘back street’ shops.
Herbal Preparations. A number
of products that are sold as herbal
preparations contain undisclosed
corticosteroids. Often these products
are produced using plants as the main
ingredient, with false medical claims, or
the products are made synthetically as
with ‘Wau Wa’ cream mentioned above.
These are sold for the treatment of many
different skin conditions such as eczema or
psoriasis, or even as skin lightening agents,
used by some Afro-Caribbean people.
Skin Lightening Agents. Another common
substance used as a skin lightening agent
is hydroquinone. Since 2000, the use of
hydroquinone in skin lightening products
has been banned completely. Despite this,
cosmetics containing this substance are
still regularly found on sale. Some products
have also been found to contain inorganic
mercury known to cause kidney, liver and
neurological damage, as well as other
adverse effects. Mercury as a metallic
element is not biodegradable and therefore
accumulates in the body.
Enforcement
Under the Cosmetic Products Regulations,
Trading Standards has the power to seize
cosmetics, but they cannot take any
action against the trader for selling illegal
medicines; they can merely attempt to
make a test purchase and notify the MHRA.
In the UK, only the MHRA is empowered
under the Medicines Act to deal with
‘human’ medicines.Trading Standards
departments have powers under the Act
to deal with medicated animal feeding
stuffs only, however, they do have powers
under the Consumer Protection Act 1987/
Cosmetic Products (Safety) Regulations
(2004) as amended.
This means that Trading Standards can
take action when they find illegal and
dangerous cosmetics, but cannot deal
with similar products if they are classed as
medicines. Equally the MHRA cannot deal
with cosmetic products.This is complicated
by the fact that the distinction between a
medicine and a cosmetic is often difficult
to determine.The result is that more
often than not,Trading Standards and
the MHRA have to work in tandem which
could be seen by some as inefficient.
Although working in partnership with
other enforcement agencies provides many
benefits, including shared intelligence and
best practices, the fact that neither agency
can act alone and deal with both illegal
medicines and cosmetics when they may
be on sale together, creates a restrictive
legislative environment for both bodies.
Whilst illegal medicines and cosmetics
can be seized by the MHRA and Trading
Standards respectively, difficulties arise in
tracing the importer when consignments
are found within other consignments,
despite the presence of ‘Bills of Lading’.1
Moreover, once the consignment is
stopped, importers are unwilling to present
themselves to account for such goods,
raising concerns regarding ’supply‘ under
both the Medicines Act and the Consumer
Protection Act.Alternatively, the importer
could attempt to use re-export provisions
claiming that the goods are in transit to
other countries where their sale is not
unlawful.
One of the key problems for the MHRA,
like so many enforcement agencies,
is its small size.With 18 enforcement
staff to cover the whole of the UK, it is
forced to act on an intelligence led basis
and is limited in the number of detailed
investigations and routine inspections it
can undertake.The MHRA relies on other
enforcement agencies such as Trading
Standards departments for intelligence, as
the latter routinely inspect trade premises.
An Investigation …
Over a period of two days, undercover
officers visited twelve shops within Brixton
town centre.Three of these shops were
engaged in selling cosmetic products
only.Two shops sold cleaning products
as the main commercial activity and the
remainder sold food.These shops were
chosen because they had a previous
history of selling both illegal medicines
and cosmetics. Inspection records show
that on discovering these products, traders
were informed as to their legal obligations
and the matter was closed. It was noted
that two stall owners identified on our
database as having a previous history of
selling unlicensed medicines containing
corticosteroids had their market licenses
revoked and were no longer trading within
the area.
At nine of these 12 addresses, Movate,
Dermovate and other corticosteroid
creams, as well as creams containing
hydroquinone were obtained from
‘under the counter’. Formal samples
were obtained and taken for testing by
an officer from the MHRA.The results
confirmed the presence of corticosteroids
in every sample.The price of these items
ranged from £1.99 to £4.99. Upon closer
examination of the product packaging, the
Movate creams and Dermovate creams
1. A bill of lading is a document issued by a carrier, e.g. a ship’s master or by a
company’s shipping department, acknowledging that specified goods have been
received on board as cargo for conveyance to a named place for delivery to the
consignee who is usually identified

3. www.pipaonline.org Issue 10 • February 2007Page 8
stated that they were “anti-inflammatory,
anti-allergic, antipruritic and indicated
in treatments of the most resistant
dermatoses.”The products also stated
that they contained clobetasol propionate
0.05%.
None of the premises visited were
registered as pharmaceutical outlets
and the individuals involved selling
the products were not registered as
pharmacists. During each test purchase,
the corticosteroids were supplied without
question. No enquiries were made as to
who the product was for, or as to the
medical status of the intended user.
The Enforcement Visit …
After completing a formal risk assessment
and liaising with the MHRA and Brixton
Police, the shops where hydroquinone and
corticosteroids were sold were revisited.
The MHRA used powers under the
Medicines Act and Trading Standards used
powers under the Consumer Protection
Act. Police officers also acted to prevent a
breach of the peace and provided a high
visibility presence in an effort to get the
message across that products of this type
are potentially dangerous.
The following relates to one enforcement
visit but all others followed the same
procedure and yielded similar results.
The target was a retailer in cosmetics
within Brixton town centre, who has
been visited on numerous occasions and
found to be in possession of both illegal
medicines and cosmetics. Upon entry to
the shop, we were told that the owner
was away on business.A member of staff
handed over a business card so that the
owner could be contacted. However, it
transpired that the owner was present, but
was unwilling to come forward to accept
responsibility.This could indicate a criminal
intent by the owner and knowledge that
the products he was selling were illegal.
Despite previous enforcement action by
the MHRA and Trading Standards against
this shop, a total of 777 illegal medicinal
and cosmetic products with a street
market value of £8,000 were seized.The
seizure included Movate, Betnovate and
Dermovate, as well as others such as
Top-Gel and Hyprogel.The more worrying
aspect of this seizure was that despite
the product name, some contained the
very potent corticosteroid clobetasol
propionate.Also included in this was a
large quantity of skin lightening creams
such as Fashion Fair, Symba and Topiclear.
It was made clear to the shop staff that
these products should only ever be used
under medical supervision because of the
potential for corticosteroid side-effects.
At the PACE interview (police and formal
caution interview), the owner said the
products seized had been obtained from a
number of individuals who visited his shop
offering to sell him goods from suitcases or
similar bags. No details of the sellers were
obtained despite statutory instrument SI
1994/3144 stating “… any person selling
or supplying an unlicensed medicine is
obliged to maintain and keep for a period
of at least five years, a record of that
supply”.Traders are also required to record
the source from which they obtained the
product, the person to whom and the date
on which the sale or supply was made, the
quantity of each sale or supply, the number
of the batch of that product from which
the sale or supply was made and details
of any suspected adverse reaction to the
product sold or supplied.
To try to match all the pieces of the jigsaw
and establish an audit trail, batch numbers
of the seized Dermovate creams were
taken.These details were then passed
to the manufacturer who subsequently
confirmed that the products were
produced either in the United Kingdom or
at its factory in Saudi Arabia for the export
market; the trail thereafter went dead.
Batch numbers relating to a sample of
three seizures in Lambeth of unlicensed
medicines were compared to the batch
numbers of four other recent seizures
in the London Borough of Southwark.
This was compiled to see if there was
any connection between the shops.The
data demonstrated that there is a clear
connection and would indicate that these
medicines are being sourced from the
same supplier, as batch numbers were the
same.To date, the supplier has not been
identified and investigations are ongoing,
but it is strongly suspected that the owner
of one of these shops is an illegal importer
such products.
During
each test
purchase,
the cortico-
steroids were
supplied
without
question.

4. www.pipaonline.orgIssue 10 • February 2007 Page 9
The practice of simply recording batch
numbers on excel spreadsheets is a
relatively new concept to the MRHA,
Southwark and Lambeth, and has
proved to be a useful intelligence tool in
connecting one trader’s illegal activities
with another.
The Legal Framework
Consumer Protection Act 1987:
Cosmetic Product Regulations. In 2000,
it was widely accepted that products
containing hydroquinone presented a
serious danger to the health of anyone
using them.The Cosmetic Products
(Safety) Regulations 2000 placed a
complete ban on the use of hydroquinone,
and subsequent changes to these
regulations have maintained the ban.
Hydroquinone is not itself classed as
a medicine, but its use in medicines is
subject to strict controls, so the majority
of products found containing it are
classified as cosmetics.
Trading Standards officers have powers
under the Consumer Protection Act 1987
to seize and detain illegal cosmetics so
when products are found containing
hydroquinone, enforcement action can
be taken.The problem is that the scope
of the Cosmetic Products Regulations
is limited even though in many cases it
overlaps with the Medicines Act due to
the nature of the products involved.
The Medicines Act. One of the main
criticisms of the Medicines Act relates
to authorised enforcement authorities.
The Act specifically empowers local
authorities to enforce the sections
relating to medicated animal feeding
stuffs but gives no powers to deal
with human medicines unless they
are pre-packed aspirin or paracetamol
tablets (GSL items—pharmaceuticals
on the General Sales List), which are
allowed to be sold in premises that are
not pharmacies; so without amending
the act,Trading Standards departments
have to work in tandem with the MHRA.
Some critics would argue that this area
of law should be left within the domain
of the MHRA, however, as highlighted
above,Trading Standards can deal with
cosmetic products where the MHRA
cannot. Moreover, the MRHA would only
inspect premises such as pharmacists and
shops selling cosmetic products. Unlike
Trading Standards they would not as a
matter of routine conduct enforcement
visits to shops selling cleaning products
or foodstuffs, unless it was intelligence
led.This highlights potential gaps in
enforcement from the MHRA point of view
unless both agencies work in tandem.
Conclusion
Consumers are purchasing illegal
corticosteroid creams and dangerous
cosmetics containing hydroquinone for
many complex reasons.The high cost of
prescription charges may have an influence
on patient behaviour and could be the
reason that patient compliance is being
undermined in Brixton and elsewhere.
Empirical evidence suggests that people
on low incomes use a lower dose of
their medicine or use it less often, so
that their prescription lasts longer. Some
prescriptions are never dispensed because
of the high prescription cost!
Unlicensed corticosteroid creams and
dangerous skin lighteners are being
imported into the United Kingdom illegally.
Whilst some of these consignment
are detected by vigilant officers of Her
Majesty’s Revenue & Customs, the MHRA
and Trading Standards, other consignments
are getting through and are finding their
way into the UK market. Cross-border
exports of medicines are allowed within
For more information, Ray can be
contacted at rbouch@lambeth.gov.uk.
the European Union (EU), so Customs,
understandably, will be more relaxed
when it comes to checking, to allow free
movement of goods.
Finally …
Companies such as GlaxoSmithKline,
Pfizer and Purdue Pharma are at
the forefront in the pharmaceutical
market because they are, or about
to, start radio tagging their products
using RFID technology in efforts
to stop drug counterfeiting.This
will enable them to track and
trace products through the entire
supply chain. Hopefully they will
be able to employ this technology
in a similar way to stop the sale
of unlicensed medicines getting
into the UK market place.
References
There are a considerable number
of references related to this article
although many are taken from the
MHRA website (www.mhra.gov.uk).
If anyone would like a complete list,
please contact Ray directly.
The Author: Ray Bouch is a
qualified Trading Standards
Officer and has over 20 years of
experience working in the field of
Trading Standards in several London
boroughs.