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Menace of counterfeit drugs
Many people no doubt think that the most dangerous industry is the one which produces bullets and missiles. These weapons do have the potential to kill thousands of people and maim countless others. But is the above assumption correct? After all, in warfare and high- and low-intensity conflicts measures can be taken to minimise casualties.
Against this background of perceived risk from weapons there is a far more commonly encountered risk, which is the one from cigarettes and alcohol. We now have irrefutable evidence showing that these substances pose serious risks to an individual’s health but both are still used by millions each day.
There is yet another group of chemicals (medicine) which is perhaps thought of by the public as posing risks to human health. However, from the outset it is fair to suggest that the risks involved are minimal.
This is so because, unlike alcohol and tobacco, medicines are among the most regulated products in the world. The potential for harm in this case can be minimised further through efforts against drug counterfeiting and through good manufacturing and storing practices. In some parts of the world, organised crime has moved from narcotics and weapons smuggling to counterfeiting of medicines, which is a lucrative but relatively low risk activity.
The menace of fake medicines is worse than the combined scourges of malaria, HIV/Aids and armed robbery. Their use has led to treatment failure and deaths, eroding public confidence in healthcare systems.
The (US) Food, Drug and Cosmetics Act of 1995 defined counterfeit medicine as: “A drug the container or labelling of which bears, without authorisation, the trademark, trade name or other identifying mark, imprint, or device or any likeness thereof, of a drug manufacturer, processor, packer, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed and distributed by such other drug manufacturer, processor, packer or distributor.”
According to a dictionary, the term “counterfeit drug” may be used to denote a drug made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or right, with a view to deceiving or defrauding, and then marketing the copied or forged drugs as the original.
The World Health Organisation says, “A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source.” Counterfeiting can apply to both branded and generic products and counterfeit products may include ones with correct ingredients, wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging.
The Pakistani manual of drug laws defines counterfeit medicine as: “A drug, the label or outer packing of which is an imitation of, resembles or so resembles as to be calculated to deceive the label or outer packing of a drug manufacturer.”
Magnitude of the problem
The menace of drug counterfeiting is not confined to developing countries but has permeated to developed countries as well. The extent of the problem, however, is not really known since no global study has been carried out.
Between 2001 and 2002 alone, 42 cases of fake drugs were reported to the WHO. About 70 per cent of these cases came from developing countries, whereas the rest were from developed countries. Although the reports received have not been validated and may not be useful for quantitative purposes, the information clearly shows that the problem exists. The data also show that only a few countries are willing to provide information about the cases detected, as the number of countries sending reports amount to less than 10-15 per cent of the WHO membership.
A recent report indicates that much of the dubious activities are masterminded from Asia. It is believe that in some extreme cases, companies may be producing legitimate goods at one end of the factory and fake ones at the other.
Drug counterfeiting mostly involves antibiotics — for instance, Amoxicillin is the most counterfeited medicine worldwide. Other fake products may include antihistamine, hormones, steroids, vasodilators, drugs for erectile disorders and anti-epileptic medicine. These drugs represent almost 80 per cent of the cases reported.
In terms of the types of counterfeits and the magnitude of the problem, the products reported can be grouped into five categories:
— Products without active ingredients, 43 per cent;
— Products with poor quality of active ingredients, 24 per cent;
— Products with less amount of active ingredients, 21 per cent;
— Products with incorrect amount of active ingredients, 7 per cent, and;
— Products with correct quantities of active ingredients but with fake packaging, 5 per cent.
Causes
The major causes of production of fake medicines are:
— Lack of political will and commitment;
— Lack of appropriate legislation;
— Absence of or weak drug regulations;
— Weak enforcement and penal sanctions;
— Corruption and conflict of interest;
— Demand exceeding supply;
— High prices of medicines;
— Inefficient cooperation between stakeholders;
— Lack of regulations by exporting countries and within free zones, and;
— Trade via several intermediaries.
To deal with the situation better, the ministry of health, Government of Pakistan, should:
— Ensure that all drug manufacturing, import, export and distribution activities are carried out on the premises approved by the drug regulatory authority and that individuals and companies engaged have licences to get involved in such activities;
— Inspect drug establishments regularly to ensure that they comply with national drug regulatory requirements;
— Ensure that all drug products are assessed and registered before they are introduced to the market;
— Inspect the informal market to prevent any illegal trade in drugs;
— Monitor the quality of drugs on the market to detect and prevent any substandard and counterfeit drugs from reaching the public;
— Work closely with national law enforcement agencies, such as the policy and custom officers;
— Inform the public about the problem of counterfeit drugs and educate and advise them to buy medicines from legitimate sources
rather than from peddlers and hawkers or from market places and streets;
— Encourage and advise consumers to report to their physicians in case their health doesn’t improve in spite of the treatment or any adverse reactions experienced;
— Foster bilateral and multilateral agreements with other countries, in particular with countries sharing common borders, to prevent cross-border trade and smuggling, and;
— Seek international cooperation with organisations such as the WHO, Interpol and the World Customs Organisation.
Consumers’ role
To deal with the situation, the consumers should:
— Buy drugs only from licensed pharmacies and drug outlets;
— Be suspicious of heavily discounted drugs;
— Not buy from peddlers or market places;
— Insist on getting receipts when buying drugs;
— Check packaging carefully to determine if it is properly sealed;
— Check if the packaging indicates the batch number, manufacturing date, expiry date and the manufacturer’s name:
— Report to your health worker or doctors any lack of improvement after taking a drug.
Conclusion
Although it may be difficult to deal effectively with counterfeiting, the menace should be viewed seriously because it puts people’s health at risk. The pharmaceutical industry’s losses in revenue due to counterfeiting are enormous, but the potential harm to a company’s reputation, when its products are affected, is also an extremely serious issue.
The writer is studying at the University of Bradford, United Kingdom
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