Leading article

Fake and counterfeit drugs: An emerging scourge or an established blight? Sri Lanka Journal of Child Health, 2007; 36: 125-6 (Key words: fake drugs, counterfeit drugs) In any part of the world, whatever precautions one of tap water; paracetamol syrup made of industrial takes, it is impossible to avoid many diseases. Some have been there from time immemorial. Many contraceptive pills made of wheat flour; and communicable diseases are the bane of the developing antimalarials, antibiotics, and snake antivenom world and non-communicable illnesses assume major importance in the developed world. Drugs used to treat human diseases are very special as they are There is good evidence that the plague of fake essential for the well-being of a community. This is medicines has spread even to the developed countries particularly relevant to paediatrics. The potency and such as the UK and the USA. In the UK in November effectiveness of medicines used to treat human diseases are generally taken for granted as they are manufacturing fake diazepam and viagra in his supposed to have been rigorously tried, tested and Wembley warehouse where Indian tablet presses and occupy a hallowed position in standardised treatment chemicals were found6. Even in a country like the USA, there are numerous instances where the problems of substandard and fake drugs have Against this backdrop, the often subtle and sometimes surfaced. Some of these have involved such diverse rampant menace of fake or counterfeit drugs is compounds as epogen, neupogen, anti-cancer drugs, causing major concerns all over the world. A anti-psychotic drugs, anti-cholesterol drugs and even counterfeit drug or a fake medicine is a medication sildenafil7. The US Food and Drug Administration which is produced and sold with the intent to estimates that fake drugs alone comprise more than deceptively represent its origin, authenticity or 10% of the global medicine market, generating annual effectiveness. A counterfeit drug may be one which sales of more than 32 billion US dollars. The general does not contain active ingredients, contains an position of the blight has now been augmented and insufficient quantity of active ingredients, or contains facilitated by the availability of all kinds of drugs entirely incorrect active ingredients (which may or without a prescription over the internet. There is no may not be harmful), and which is typically sold with control whatsoever on this phenomenon and there is inaccurate, incorrect, or fake packaging. Fake evidence that counterfeit drugs are being made medicines and generic drugs which are deliberately available by unscrupulous agencies through this route. mislabelled in order to deceive consumers are therefore counterfeit1. The British Medical Journal, in In point of fact, counterfeiting pills, labels and an editorial, called it “Murder by fake drugs”2. It goes packages is relatively simple. Most of the tools on to postulate that 8% of drugs bought in the needed to produce authentic-looking but counterfeit Philippines were fake. Major problems were also drugs and packaging can be bought over the Internet. found in the antimalarial drug mefloquine in Much of the counterfeit drug trade is probably linked Cambodia and artesunate in five countries of South- to organised crime, corruption, the narcotics trade, East Asia. In a study of shop-bought samples of unregulated pharmaceutical companies, and the artesunate in Cambodia, Laos, Myanmar, Thailand business interests of unscrupulous politicians8. Much and Vietnam, 38% did not contain artesunate3. greater international political will to eliminate the However, characteristics such as cost and physical problem is required. Globally, technical, logistical and appearance of the tablets and packaging reliably financial support, possibly through specialised non- predicted authenticity. The authors concluded that the governmental organisations, is needed to allow illicit trade in counterfeit antimalarials is a great threat impoverished countries to protect their drug supplies. Sophisticated techniques, which are hard to copy, such as holograms and fluorescent markers, can be The World Health Organisation estimates that up to used to brand the genuine product as real, but they are 25% of medicines consumed in developing nations are often too expensive. Simple, inexpensive and low tech counterfeit or sub-standard4. In a specific study on methods to identify fakes should be pursued. chloroquine and selected antibacterials in Nigeria and Measures would include supporting drug regulatory Thailand, 36.5% of the samples were substandard authorities; providing simple, easily interpretable and with respect to pharmacopoeial limits5. There is mounting evidence that malevolent dealings in international surveillance for fake and substandard counterfeit drugs are very much a thing of the present drugs, improving the availability of quality assured world. Notorious recent real examples include essential drugs and educating patients, healthcare neomycin eye drops and meningococcal vaccine made workers, and pharmacists. All measures that reduce the profit margins for manufacturing fakes, such as reducing the price and increasing the availability of It is high time that the general population and the pressure groups realise that one cannot have the cake counterfeiting a less attractive criminal activity. and eat it as well. It should be a sobering thought to Uncompromising international police action against the authorities that even in the UK, where prescribing the factories and distribution networks needs the same is only by generic names, there have been well vigour as that associated with the pursuit of narcotic documented instances of fake and counterfeit drugs There is little published medical research assessing the prevalence, public health impact or possible countermeasures, of and on, these malicious deceptions. The accumulated evidence, such as it is, http://en.wikipedia.org/wiki/Counterfeit_drug. suggests that mortality and morbidity arising from this murderous trade are considerable, especially in 2. Newton PN, White NJ, Rozendaal JA, Green developing countries. They have also given rise to MD. Murder by fake drugs. BMJ (Editorial) misperceptions of drug resistance as patients "fail" their ineffectual treatments. For example, artesunate resistance reported from Cambodia turned out to be 3. Li A, Po W. Too much, too little, or none at all: due to unwitting use of fake drugs. The World Health dealing with substandard and fake drugs. pharmaceutical commerce is in fakes9. In the past, drug companies have tended to avoid publicising these problems for fear of damaging public http://news.bbc.co.uk/2/hi/health/3261385.stm. confidence in medicines. Most unfortunately, some countries, well aware of the scale of their problem, 5. Shakoor O, Taylor RB, Behrens RH. Assessment of the incidence of substandard drugs in developing countries. Trop. Med and Int .Health There is a growing voice in Sri Lanka, fuelled by public interest groups, patient rights organisations, politicians and even the government, to compel doctors to prescribe by the generic names of drugs. http://news.bbc.co.uk/1/hi/programmes/this_worl The often quoted reason is that some doctors have been “bought over” by multinational drug companies to prescribe by trade names. Sri Lanka does not possess the sophisticated machinery which enables http://www.biopsychiatry.com/pharmacy/fake- regular testing of drugs for physical properties, potency and biological availability in humans. It is also quite impossible to test the vast array of different 8. Saywell T, McManus J. What's in that pill? Far drugs available for treating a multitude of illnesses. If Eastern Economic Review. 21 Feb 2002, pp 34- such facilities are in place and just a few properly tested generic version of a given drug are made available, there is no excuse for doctors to prescribe by trade name. In the absence of such amenities, one substandard drugs in Myanmar and Vietnam. has to at least go by the data available from testing in WHO/EDM/QSM/99.3. In: Geneva: WHO, 1999. other countries. The so called free market economy in Sri Lanka has gone berserk in the pharmaceutical trade. Our own authorities, on the one hand, allow large numbers of branded products of the same drug to be registered, imported and made available in the pharmacies and then cry foul saying that the doctors are prescribing by trade names. Many doctors do so, especially for children, simply because the branded drugs are of assured quality and not because they are carrying a brief for the multi-national drug companies.

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