Publications 1. Cintora-Gonzalez, O., Estournes, C., Guille, J.L., Grob, J.J., Honerlage, B., Lemoigne, J., Levy, R., Lutz, T., Merle, J.C., Muller, D., Richard, M., Rehspringer, J.L., Schell, J., Viart, N. "Aggregates in silica based matrices." Analusis 28 109 - 113, 2000. 2. Felder, D., Guillon, D., Levy, R., Mathis, A., Nicoud, J.F., Nierengarten, J.F., Rehspringer, J.L., Schell,
Health sciences authoritySINGAPORE, 4 OCTOBER 2001
HEALTH SCIENCES AUTHORITY
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
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
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