SINGAPORE, 4 OCTOBER 2001 HEALTH SCIENCES AUTHORITY PRESS RELEASE HSA INVESTIGATES COUNTERFEIT VIAGRA
The Health Sciences Authority (HSA) through our Centre for Pharmaceutical
Administration (CPA) commenced an investigation on 23 July 2001 upon the receipt of
information from Pfizer Pte Ltd (Pfizer) that counterfeit Viagra was supposedly available
at Redhill market, Bukit Merah and Jurong. According to Pfizer, the information
together with samples of the suspected counterfeit item, had been provided by a doctor.
RESULTS OF THE INVESTIGATION
Over a period of more than two weeks, CPA conducted regular covert
surveillance in at least 30 suspected locations in the Redhill, Bukit Merah, Jurong
(Jurong East and Jurong West) and Boon Lay areas, targeting locations indicated by
Pfizer in its initial feedback and another location reported by the media later on 7 Aug
2001. CPA’s officers interviewed a number of witnesses and followed up on the leads
and information obtained. In a particular lead, information surfaced that the sale of the
counterfeit Viagra might have occurred previously in a location at Block 214 in Jurong
East which was subjected to surveillance.
During the periods of surveillance, there was no detection of any activity relating
to the sale of counterfeit Viagra and HSA has not apprehended any suspects. The
findings from our surveillance and interviews strongly suggest that this incident involved
one or two individuals selling small quantities of counterfeit Viagra and that the stocks
were already exhausted. HSA has therefore concluded that this is an isolated
occurrence and that it is unlikely that there is any widespread sale of counterfeit Viagra
The samples submitted by Pfizer were sent to HSA’s Centre for Analytical
Science for analysis. The chemical assay found wide variations in the content of
sildenafil, the active ingredient in Viagra.
Through collaboration with our counterpart in Australia, the Therapeutic Goods
Administration (TGA), we have established that the packaging of the samples mimics
the Australian packaging of Viagra but with the absence of the batch number and expiry
date from the outer carton. Based on the analytical investigation and a detailed
examination and comparison of the packaging together, HSA has concluded that the
samples are counterfeit versions of Viagra. COUNTERFEIT DRUGS ON THE INTERNATIONAL SCENE
HSA has been monitoring closely the situation on counterfeit drugs as it is a
world-wide concern. We have information on reports of counterfeit Viagra in other
countries and around the region. Such information is available from our collaboration
with other overseas regulatory agencies and our participation in international networks
such as the Permanent Forum on International Pharmaceutical Crime.*
The production of counterfeit drugs, especially ‘high quality’ fakes that closely
resemble the authentic product, is a complex process that usually involves organised
Noting that counterfeits produced elsewhere could find their way here, being
brought into Singapore in small quantities by travellers, we have sought the Customs &
Excise Department’s assistance to detain any import of suspected counterfeit Viagra
and other drugs into Singapore. We also maintain our vigilance and continue
surveillance for counterfeit drugs that may appear in the local market. A REMINDER ON SAFE DRUG PRACTICES
HSA would like to remind the public not to purchase any medicinal products,
especially prescription-only medicines such as Viagra, from dubious and illegal sources
as the safety, efficacy and quality of the products cannot be vouched for. For the same
reasons, we would also like to caution the public against purchasing medicinal products
over the Internet from foreign or unknown sources.
In addition to the danger of receiving counterfeit drugs when purchasing from
dubious or illegal sources, it is also dangerous if the product itself is a potent
prescription medicine that should only be taken according to a doctor’s instructions. Viagra is a drug that must be taken under proper medical supervision and for the
correct indication as it can cause serious adverse cardiovascular effects which have
Sildenafil, the active ingredient in Viagra, is a substance controlled under the
Poisons Act, and it is an offence for an unlicensed person to import, sell or possess for
sale any product containing a poison. Anyone found guilty of an offence under the
Poisons Act is liable to a fine of up to $10,000 and/or imprisonment for a term of up to
two years. Since 1998, HSA has investigated a number of cases involving the illegal
sale of Viagra, and four people have been charged and convicted in Court for such
offences. HSA has also recently completed investigations into another case involving
the illegal sale of Viagra, and is proceeding with legal action. WHAT THE PUBLIC CAN DO TO HELP
While HSA has a comprehensive regulatory system in place to protect the public
against counterfeit drugs and the illegal sale of drugs, the enforcement of these controls
can be made more effective with the co-operation of the public. HSA encourages
members of the public to report any medicinal products that they suspect are
counterfeits or are being illegally sold (see also Annex A on Patient Education Information :How to Spot Counterfeit Drugs). Reports can be made to our
inspectors at CPA, HSA during office hours as follows:
Surveillance & Enforcement DivisionCentre for Pharmaceutical AdministrationHealth Sciences Authority2, Jalan Bukit Merah
HEALTH SCIENCES AUTHORITY 4 OCTOBER 2001 * Notes to the Editor
The Permanent Forum on International Pharmaceutical Crime (PFIPC) was
established in 1998 as a grouping of medicines regulatory agencies from various
countries and related international organizations, to discuss enforcement efforts
against illegal activities involving medicinal products, including the issue of
Currently, the members of PFIPC include the US Food and Drug Administration, the
UK Medicines Control Agency, Australia’s Therapeutic Goods Administration,
together with medicines regulatory agencies from other countries such as Belgium,
Canada, Germany, Ireland, Northern Ireland and the Netherlands, as well as
international organizations such as Interpol, World Customs Organisation and World
Health Organisation. HSA’s Centre for Pharmaceutical Administration is the first
and only member from Asia in the grouping. SINGAPORE, 4 OCTOBER 2001 HEALTH SCIENCES AUTHORITY PRESS RELEASE HSA INVESTIGATES COUNTERFEIT VIAGRA PATIENT EDUCATION INFORMATION : HOW TO SPOT COUNTERFEIT DRUGS A. Content of Counterfeit Drugs
• Although the packaging of some counterfeit drugs may closely resemble the
authentic product, the counterfeit may not contain the actual active substance.
• Even when the active substance is actually present in a counterfeit, its level of
content may vary widely – from very low levels, to very high levels, even
• Counterfeit drugs may sometimes contain other substances or substitutes that
• Counterfeit drugs can also sometimes be expired products that may cause
adverse effects or do not deliver the intended effects. B. How To Spot Counterfeit Drugs & What To Do
1. If you have used a particular product before, look at the product and check for
any difference in the appearance of the packaging or the drug itself.
• On the packaging, look out for the following :
- design e.g. missing logo, different layout of packaging design;
- colours e.g. faded colours, different colours;
- words e.g. missing text, different font-type, different point size;
- omission of expiry dates, batch numbers.
• On the drug itself, look out for changes in :
- size e.g. slightly smaller or bigger than before;
- colour e.g. different colour, different shading;
- markings e.g. small logo/words printed or embossed on the drug.
2. If you find any difference in the appearance of the product, as described above,
you should make inquiries with your doctor or pharmacist.
3. If you have been taking a particular product for some time, and notice your body
responding differently (e.g. new symptoms, adverse reactions), or not at all, you
4. If you suspect that you have been given a counterfeit drug, report the matter to
the Centre for Pharmaceutical Administration of HSA during office hours as
Surveillance & Enforcement DivisionCentre for Pharmaceutical AdministrationHealth Sciences Authority2, Jalan Bukit MerahSingapore 169547
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology M. Dianne Murphy, MD Director, Office of Pediatric Therapeutics (OPT), OIASI Office of the Commissioner CDR Lisa L. Mathis, USPHS, MD Associate Director, Pediatric and Maternal Health Team (PMHS) Office of New Drugs La
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SINGAPORE, 4 OCTOBER 2001