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by Shanika Sriyananda

Sakuntala, she, came to the city from a very remote village, looking for a better life and some extra money, she found a job as a juki machine operator and though she had found a better life when she became 'friendly' with a youth from the city. She spent most of her salary on the youth. Days passed. Her boy friend, whom she trusted with her life and her money, robbed her virginity and disappeared never to be seen again. With no idea where he lived she went from one boarding place to another looking for him.

Quite soon she began vomiting in the morning. Her friends forced her to take a pregnancy test. But it proved negative. She went back to work. Weeks passed, but she continued to suffer from the same complications. The doctor gave her medicine for gastritis. Four and half months later she began to shown signs of pregnancy.

Finally she and her friends decided to visit a 'medical centre', which was very popular in the area for abortions.

The un-qualified 'doctor', who was a former apothecary, killed the five-months-old fetus using an iron rod and charged Rs. 7,500. Sakunthala, the 22-years-old girl from a very rural village in Anuradhapura, died due to haemorrhage, the following day.

Though she died due to an illegal abortion, health experts attribute the death to the incorrect pregnancy test, which prevented her from taking timely precautions to terminate the pregnancy. The tragedy, that culminated in death, is just a case in point about the far reaching repercussions of fake medicine and medical paraphaenalia can have on human life.

Selling fake Pregnancy Test Strips and contraceptive injections is a profitable trade in the free trade zone, which has also acquired notoriety for illegal abortions. "Misled by the results of the fake Pregnancy tests, some young girls in the free trade zones have ended up loosing their lives from unsafe abortions", said P. Madarasinghe, Drug and Food Inspector of the Drug Regulatory Authority (DRA), Ministry of Health, who detected a large quantity of fake Pregnancy Test Strips from local pharmacies, recently.

Counterfeit medicines has become a thriving business around the world, according to the World Health Organisation (WHO), which launched an action plan against substandard and counterfeit medicines, which pose great health risk and often lead to death. Antibiotics, anti-malaria drugs and drugs that are used for tuberculosis, malaria and HIV/AIDS are counterfeited commonly in Cambodia, China, Laos, Myanmar, Thailand and Vietnam, while most fake drugs for heart, diabetics and hypertension are manufactured in India and China.

The WHO cautioned developing countries to keep tabs on anti malarial drugs, as more substandard and counterfeit medicines are likely to entre malaria endemic countries. Anti malarials are among the most widely counterfeited drug in the developing world and according to WHO reports, over 38 per cent of the major anti malarial drug 'artesunate' in South East Asia was fake.

The WHO estimates that over 10 per cent of the drugs in the world's pharmaceutical market are fake. Nearly 85 per cent of the world's prescription drugs are consumed in developed countries, where there are tough regulations and counterfeits are rare. But over 25 per cent of drugs including pills, tablets, liquids and powders sold in the developing countries are fake. It also states that 35 per cent of fake drugs produced in the world come from India and 20 per cent of medicines sold in India are fake.

The WHO estimates is an ominous warning for Sri Lanka, which imports a high percentage of drugs from India because of the low cost. It is also a warning for patient who opt for the cheaper product to cut down on cost. But warnings aside, just how serious in the counterfeit drug trade in Sri Lanka ?

According to experts, the situation is under control to some extent with the tight surveillance system of the Drug Regulatory Authority (DRA), which keeps tab on importers and pharmacies in the country. But, due to loopholes and outdated punishments for counterfeiting, the business is prevalent, vibrant and growing albeit slowly.

"We are battling a tough war with unscrupulous pharmaceutical traders", said Dr. B. F. S. Samaranayake, Director (Medical Technology and Supplies), claiming that all unregistered drugs that come into the market are counterfeit drugs. "Drug importers have to register and get a licence from the Drug Regulatory Authority (DRA) before the importation. All drugs that import to the country will undergo a thorough laboratory test to ensure their quality, safety and efficacy.", Dr. Samaranayake said.

However, large quantities are sneaked into the country by individuals and organised gang giving credence to claims of a thriving counterfeit industry.

The legal framework for drug regulatory control in Sri Lanka is the Cosmetic, Devices and Drugs Act No 27 of 1980, which has provisions to manufacture, import and sell cosmetics, devices and drugs after they are registered with the DRA.

However, due to loopholes in laws related to the pharmaceutical trade, Sri Lanka has become a good market for expired drugs, unregistered drugs and also for counterfeit pharmaceutical products. "The main problem in Sri Lanka is the re-labelling of cheaper drugs to be sold at higher prices", said Madarasinghe, adding that it was a common practice of the local fake pharmaceutical traders due to slow moving of the cheap drugs in the market.

He said that most counterfeits had sophisticated duplicating packaging, holograms, company logos and bar codes. " It is sometimes impossible for consumers to tell the difference between a counterfeit and a genuine product. Pharmacists, doctors and law enforcement officers can be fooled", he admitted.

Over 85 per cent of the total pharmaceutical imports into the country, are from India, which is the second largest hub for manufacturing fake pharmaceutical. The rest is imported from China, Pakistan, England, Korea and Thailand. " Since a larger portion of the country's drug requirement is fulfilled by India, we run the risk of getting fake drugs from there", said Madarasinghe.

According to Madarasinghe, although there are a few domestic pharmaceutical manufacturers in the country who were registered with the DRA, most counterfeit drugs enter the country hidden in baggages.

He stressed the need for patients' vigilant over fake pharmaceutical as a majority of fakes are drugs for the treatment of diabetics, heart, cholesterol and hypertension.

"Compared to other countries, it is easy to control the counterfeit trade here as Sri Lanka is an island, where we have tight checking facilities and there are only two entry points- the port and the airport.

Madarasinghe said that responsible patients, pharmacists and doctors can control the business to a greater extent. " Always be vigilant about the drugs you buy, prescribe and issue", he pointed out.

No counterfeit drugs go to state hospitals, but the substandard drugs are a problem. According to Madarasinghe 48 substandard drugs had been withdrawn from state hospitals last year and 11 drugs this year.

There are over 2,500 private pharmacies registered with the DRA. Authorised officers - food and drug inspectors, divisional pharmacists and medical officers of health - have been given the authority to inspect any pharmacy in the country and to take action against them. "When we detect a fake drug from one pharmacy we withdraw the entire stock from all pharmacies. The drugs will be confiscated and legal action will be taken against those who sell the fake drug", he warned. However, the outdated fines, which does not amount to more than Rs. 5,000 for the offence have encouraged businessmen to continue with their illegal trade.

On the other hand, laws delays in proving the offence has also proved to be a major loophole in the law enforcement process. " The case filed against a pharmaceutical trader in Kakirawe in 1994 is still pending at the Anuradhapura High Court", said Madarasinghe who has been going to Anuradhapura for the last nine years to give evidence.

The delays and the fines notwithstanding, the DRA has filed over 124 cases against drug traders in 2002 and 80 cases this year.

Meanwhile, Dr. Samaranayake said that the fine would be increased to Rs. 100,000 soon to give more impetus to control the counterfeit drug trade. "It is now with the Legal Draftsman and will be submitted to the Cabinet soon", he said.

The DRA commenced an islandwide awareness programme for pharmacist to educate them on counterfeit pharmaceutical, their health effects and easy identification. "We started awareness programmes for pharmacists in all parts of the country, excluding Jaffna", said Dr. Samaranayake, adding that pharmacists and doctors could play a major role in controlling the fake drug business.

"Pharmacist should always take drugs from legitimate wholesale dealers and avoid taking small quantities of pills and liquids from those who bring in hand baggages. If there is a slight change in the appearance of the drugs, that they regular purchase, inform the DRA for further testing", he pointed out.

Dr. Samaranayake requested doctors to be more vigilant about counterfeits. "Always be suspicious about the drugs which are not giving the expected cure and inform about them to the DRA, with a sample for testing of the efficacy of the drug", he said.

H. Attapattu, Assistant Director, Customs, Baggage Division, Bandaranaike International Airport said that of the total detection from January to October this year, 80 per cent of the drugs were counterfeit 'Depoprovera' contraceptive injections. " During the last eight months, the customs detected Rs. 10 million worth of counterfeit pharmaceutical brought into the country hidden in baggages. Out of that, Rs. 8 million worth counterfeits are 'Depoprovera' injections", he said.

The custom officials have also detected counterfeits of cancer and kidney drugs, which were brought from Pakistan.

However, another massive consignment of counterfeit pharmaceutical were detected by the custom officials at the Sri Lanka Ports Authority on November 20. P.B. Kulatunge, Superintendent of Customs said that the counterfeits were hidden in a container declared as containing plaster of paris shipped from Pakistan. " This also belonged to a Pakistani national, married to a Sri Lankan woman", he said.

The counterfeit drug container comprised 10,000 Depoprovera injections worth Rs. 1.2 million, 20,000 Metformin tablets (for diabetics) worth Rs. 100,000, 10,000 Megril tablets ( a pain killer) worth Rs. 100,000 and 400 cans Bevalec syrup (antibiotic) worth of Rs. 400,000.

The pharmaceutical importer needs two documents - an approval from the Cosmetic Devices and Drugs Authority and also from the Controller of Imports and Exports. "Imports without these documents are deemed illegal and when custom officials detect an illegal baggage, a fine depending on the value of the goods will be charged. The drug stocks will be confiscated under Chapter 235 of the Customs Ordinance and will not release to the open market for selling", Atapattu said.

What is a counterfeit pharmaceutical

* A product - that is deliberately mis-labelled to hide its the identity or source

- has wrong ingredients
- does not have active ingredients.
- has an insufficient quality active ingredients
- with fake packaging

Counterfeit drugs are extremely difficult to detect and are marketed in a bewildering variety of forms. The fakes may be harmless or they may have impurities, contaminants and even toxic substance. They could be rejected or out-of-date formulas withdrawn from the market by the manufacturers.

According to British consulting firm Reconnaissance International, more than half of all counterfeit drugs contain no active ingredients or contain the wrong ones. Nearly 10 per cent contain contaminants.

Source: Drug Regulatory Authority

*****

Counterfeits and smuggled drugs detected by the Drug Regulatory Authority (DRA)

* FLEMNIL : Over Rs. 1.6 million worth expectorant liquid for cough and colds which was expired but re-labelled detected in 2000 following a complaint by a doctor. The lid said the product was herbal but according to the label it is a western medicine.

* FEROVIT - A vitamin manufactured in Thailand and detected in 2000 with re-printed labels from a Kotahena press.

* VIAGRA

* DELTOL plaster fabric - Rs. 1.3 million worth plasters manufactured in Kaduwella, detected in September this year. The factory, which was not upto the required standard was closed down.

* Sloan's liniment - Following a complaint by the local manufacturer, the counterfeit version of the liniment, which is reddish in colour (Colour of the original oil is brown) was detected in February 2003.

* Pregnancy test strips : Detected and destroyed in 2003.

* NICARDIA RETARD : Counterfeit drug stocks of this brand was withdrawn following a complaint made by the registered importer of the Nicardia Retard - George Steuart Agencies, recently.

* In 2000, the DRA detected Rs. 5 million worth counterfeit and smuggled drugs. The worth of counterfeit and smuggled drugs in 2001, 2002, and 11 months of 2003 are Rs. 6 million, Rs. 2.5 million and Rs. 1 million respectively.

*****

Some tips to protect yourself from fake drugs

1. Buy drugs only from licensed pharmacies and reputed drug outlets and be wary of inter-net offers. Do not buy from peddlers or marketplaces.

2. Be suspicious of drugs at heavily discounted rates.

3. Insist on a receipt.

4. Check that the packaging is properly sealed.

5. Ensure packing indicates the batch number, manufacturing date, expiry date and the manufacturer's name.

6. Check that the names of the drug and the manufacturer are spelled correctly.

7.Report any lack of improvement in your health after taking a drug to your doctor or health worker.

Source: Global Forum on Pharmaceutical Anti counterfeiting

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