The other war on drugs

When Duangjai feels depressed, she can easily buy the anti-depressant medicine her doctor prescribes for her at a local pharmacy. The problem is, she can't be sure if the medicine she gets is genuine or fake. According to the Food and Drug Administration (FDA), under the Ministry of Public Health, counterfeit drugs have permeated the market in recent years and the makers have become more sophisticated, churning out pills and packaging that are almost indistinguishable from the real thing, especially for the average consumer.

In determining which drugs are counterfeit, the FDA looks for things like irregularities in the bar code on packages, differences in the sealing or printing of packages, or in the pattern of surface blisters of pills or miniscule variations in the thickness of tablets.

But after laboratory analysis, say FDA officials, the differences are much more apparent. Fake pharmaceuticals often have extremely varied compositions and some contain ineffective or dangerous substances that can cause illness, injury and even death. Some contain totally inert substances like starch, while others are made of cheap materials like paracetamol.

Actually, there is a controversy raging over what constitutes a fake drug, (see Page 6). Smuggled medicines which are seized by the authorities include not only counterfeit copies of drugs, but also unauthorised generic drugs, medicines whose ingredients have not been registered with the Thai FDA and those whose formulas or ingredients have been taken off the FDA approved list.

According to the FDA Drug Control division, the smuggling of these medicines has been on the increase. The most commonly smuggled are fake or generic treatments for erectile dysfunction (ED), malaria and also illegal and possibly fake hormones.

Some other commonly seized items are fake or generic mycophenolate mofetil, used primarily to ease the acceptance of transplanted organs, and ollanzapine, for patients with symptoms of depression, as well as nandrolone decanoate, a popular anabolic steroid, both genuine and fake.

Officials say they are concerned that knock-offs of expensive drugs for HIV/Aids treatment, high blood pressure and cancer would become future problems.

During a recent meeting on counterfeit medicines, Praphon Angtrakool, director of the FDA Import and Export Inspection division, estimated that the value of the seized medicines is only 1% of the actual amount smuggled into the country.

Last year about 67 billion baht worth of legitimate medicines were imported into Thailand, while local pharmaceutical companies produced about 36 billion baht worth for domestic use and export.

Mr Praphon said that most ED medication, malaria and tuberculosis drugs that are marketed in Thailand via the internet, are fakes. Some are sent through courier services or the mail. He warned that people who use a specific drug without consulting a physician first run the risk of taking fake drugs with possibly life-threatening side effects, especially people with certain medical conditions. The Customs Department is the first line of defence against smuggled counterfeit medicine.

''In fiscal year 2007, we seized counterfeit drugs worth 25 million baht, the highest amount of the past four years. We are not a route to other countries. Medicines smuggled into Thailand will end up at pharmacies here or on sale on the internet,'' said Somchai Poolsavasdi, deputy director-general for enforcement at the Customs Department.

However, he said, at this time smuggling is believed to be handled by a relatively small group of operators, and has not yet evolved into a big crime syndicate. This is different from the narcotics smuggling trade, said Mr Somchai.

Customs officials normally pay special attention to foreign nationals who come from countries where the production of counterfeit pharmaceuticals is based.

''Certain merchants who operate in import and export with those countries will take along fake medicines [when they come to Thailand]. In many cases we have found business people carrying bags full of counterfeit medicines,'' said the deputy director, who added that if the demand increases, so will the supply. He thinks there is a high possibility that the business might become attractive to criminal syndicates, as the profit potential is vast. At the same time, the punishment for those who get caught is typically much less severe than for narcotics .

Mr Somchai said his department cannot estimate the amounts of fake drugs which are successfully smuggled into the country, but noted that the FDA sometimes seizes them from the pharmacies themselves. He added that they can also often be easily bought in neighbouring countries, and emphasised that public awareness of the dangers of counterfeit drugs is essential to solve the problem.

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Wuthiphong Thaolar, a technical officer in the Customs Department's Post Credit Bureau, explained that whenever Customs officials find drugs, fake or otherwise, they ask for a document from the FDA showing permission for import. Without such documentation, all medicines will be seized.

He added that normally anyone having the document from the FDA would not be bringing in counterfeit medicines.

''It is easier to smuggle other counterfeit products which do not require any documents of permission from any authority,'' noted Mr Wuthiphong, who previously worked for the Investigation and Suppression Bureau of the Customs Department for a number of years.

He said that that the medicines seized by the customs officials are mainly drugs which are not registered with the Thai FDA, and medicines produced under fake brand names.

Due to the strict control at border checkpoints, the smugglers naturally use paths across the border that avoid the checkpoints. Last month a foreign couple was arrested by a military unit along the Thai-Cambodia border in Sa Kaeo province. They hired Cambodian men to carry boxes with a total of 84,800 tablets of generic loperamide _ an anti-diarrheal medication _ from Poi Pet into Thailand. ''There are many channels along the long border whereby drugs can be successfully smuggled into the country,'' said the official.

Seized fake medicines are routinely destroyed by the Customs Department, while those smuggled genuine drugs or generics will be handed over to the FDA, which destroys them also, said Mr Wuthiphong.

''The quality of medicines depends upon where and how they have been kept. Therefore it is too risky to use them,'' he said.

Besides working with Customs officials at border checkpoints, FDA officials also work with the Police Suppression Division and the Department of Special Investigation (DSI) to routinely raid pharmacies and drug stores suspected of selling counterfeit or unauthorised drugs. In one recent joint suppression operation a big pharmacy in Bang Rak district was raided and fake drugs worth more than 25 million baht were seized.

Most of them were ED drugs manufactured in China, India and Pakistan, which are big centres for such production. Other medicines seized include the anti-viral Tamiflu (oseltamivir phosphate), which requires a prescription and can only be sold in hospital pharmacies.

A recent raid in the Yaowarat area of Bangkok found a large amount of illegal ED medicines worth more than 15 million baht on sale in pharmacies and drug stores.

According to police, the fake and unauthorised medicines are smuggled into the country by foreigners and sold to the big shops, which then distribute them to smaller shops, and are also sold over the internet.

Thailand is also alleged to be a country where fake medicines are produced. In 2004, the World Health Organisation (WHO) investigated the Cambodian pharmaceuticals market and reported that most of the counterfeit drugs on sale, including antibiotics, penicillin, paracetamol and vitamin C tablets, were produced by illegal factories in Thailand. Following the investigation, it was discovered that some of the medicines were not registered with the Thai Drug Regulation System, and that despite being labelled ''Made in Thailand'', the names and addresses of the factories were often false.

When fake and substandard malaria drugs pop up, besides cooperation among Thai agencies, the International Criminal Police Organisation (Interpol) has also set up a task force to intervene. Mr Wuthiphong said that a widespread problem in Southeast Asia has been the false labelling of the drug chloroquine as quinine. Quinine is more expensive, and besides, chloroquine is no longer recommended for treatment of malaria. Interpol reports that an operation to end this practice was deployed for five months in Cambodia, China, Laos, Burma, Singapore, Thailand and Vietnam, and resulted in more than 200 raids leading to 27 arrests and the seizure of more than 16 million tablets of substandard medicines with an estimated value of 551 million baht.