Spurious Drugs, Spurious Health: Who is to Blame?

chillibreeze writer — Sreejit S

According to WHO, a drug is defined as “any substance or product that is used or intended to be used to modify or explore the physiological systems or pathological states for the benefit of the recipient.” Drugs play a vital role in preventing diseases, restoring health and saving lives. In fact, the life expectancy of human beings has drastically improved after the introduction of highly effective modern drugs. The drugs should prove their safety, efficacy and improve quality of life before being introduced into the markets. There are various regulatory authorities to ensure these things. Yet there are plenty of spurious drugs available in our markets. The term ‘counterfeit’ is commonly used worldwide to define spurious drugs. Sometimes it is also known as a ‘misbranded drug’ or an ‘adulterated drug’. Even though the problem of counterfeiting has been reported in all parts of the world, it acquires more serious dimensions as far as medicines are involved.

According to U.S. Food and Drug Administration spurious drugs can be defined as those sold under a product name without proper authorization. The Food and Drug Administration, USA defines counterfeit drug as a “drug which, or the container of which, or labeling of which, without authorization, bears the trademark, trade name, other identifying mark, imprint or device or any likeness there of a drug manufacturer, processor, packer, or distributor other than the person, or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such other drug manufacturer, processor, packer, or distributor.” Spurious medicines are available in all countries and represent about 10% of global medicines trade. According to WHO stats, India accounts for 35% of the spurious drugs followed by Nigeria (23%) and Pakistan (15%).

A patient who receives a spurious drug may be at risk for a number of health reasons. Unexpected side effects, allergic reactions, or a worsened state of his medical condition may be experienced. Some fake drugs contain inert substances instead of active ingredients, and do not provide the patient any treatment benefit. Spurious drugs may also contain incorrect ingredients, improper dosages of the correct ingredients, or they may contain hazardous ingredients. The repeated use of these drugs can lead to therapeutic failure and even death. Furthermore, since the makers of spurious drugs do not pay any taxes, the government revenue also decreases. Thus these products also have a negative impact on industrial growth.

Huge networks involved in manufacturing spurious drugs have evolved over the years. These networks usually include manufacturers, importers, distributors, retailers, inspection agents, shipping agents and corrupt government officials of drug regulatory agencies, customs and police – a network way too strong and extensive.

Different types of spurious drugs include:

Drugs that are manufactured under a name which belongs to another drug,
Drugs that are an imitation of, or are substitutes for other drugs or resemble other drugs in a manner likely to deceive people,
Drugs whose labels or containers bear the name of individuals or companies claiming to be manufacturers of the drug; drugs that do not exist at all
Drugs that claim to be the product of a manufacturer of whom it is not truly a product.

Counterfeiting is applicable to both brand name and generic products. Products without the active ingredient, with an insufficient quantity of the active ingredient, with the wrong active ingredient, or with fake packaging come under spurious drugs.

It starts with simple imitation techniques. The fake drug manufacturers imitate the brand name, design, printing mode and even color pattern of the packaging material. This creates confusion in the mind of consumers. Unfortunately, several pharmacists are also involved in this process. One of the methods adopted to make spurious drugs is recycling. Expensive powder injections like beta-lactam antibiotics are made using this method. Refilling and relabeling are methods also adopted to make spurious drugs. In this method, the culprits identify expensive branded drugs and then buy cheaper drugs having compositions similar to the branded product. They then remove the labels and other packing material, affix the label of the branded product and pack it in in a way that is identical to the branded product. Sometimes the product may look similar to a branded or generic product in appearance, but may contain a cheaper generic drug.

Since 1984, WHO started building a database of spurious drugs to prevent their usage. There are some companies in Asia that were found to be producing high quality drugs at one end of their factory and the spurious ones at the other. Several potential factors contribute to the increase of spurious drugs. Some of the more important ones are:

Lack of enforcement of existing laws,
Widespread corruption,
Lack of coordination between various agencies,
Availability of improved printing technology and very high profit.

The drugs and cosmetics act is not enforced satisfactorily in most of the countries. The problems in the regulatory systems also facilitate development the spurious drugs.

Drugs are one of the most important elements in public healthcare, so the quality of drugs is of utmost importance as these are consumed by ailing patients. In the absence of proper compliance to good manufacturing practices (GMP), it is difficult to assure the quality of drugs manufactured by the companies. The concerned authorities should take serious action to prevent spurious drugs from being manufactured. Also the common man should be made aware of the problems that these kinds of medicines can produce. A good coordination among different departments is also an essential element in preventing counterfeiting. The government, common people, regulatory authorities and pharmaceutical companies should join their hands to prevent spurious drugs and to protect the health of people.

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Sreejit writes for chillibreeze.

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