The New Straits Times, August 1, 1997
Q: Recently, I came across the issue of fake drugs which are said to constitute about 40 per cent of the available drugs in the country. Can you elaborate on what these drugs are and the danger associated with using fake drugs?
A: Fake drugs are drugs which are marketed with the same tradename and appearance as the original products. Although these products are similar in every aspect to their original, differences do exist between them; for example, in the form of the content of the active ingredient, manufacturing processes which are carried out in the production of the dosage form or the excipients being used in producing the dosage forms.
Since fake drugs are being produced by unscrupulous manufacturers on unlicensed premised, it can be therefore assumed that these products are being manufactured without the proper procedures being followed as required for pharmaceutical dosage forms.
Genuine pharmaceutical products, however, have been subjected to various processes to ensure that such products are safe to be used, of high quality and will produce their intended actions when used.
The establishment of such processes has been provided under the Sale of Drug and Cosmetic Act 1952 (Amended 1989). Under the Act, the manufacturing operation for a pharmaceutical product has to be carried out in an approved premise under the supervison of a qualified pharmacist.
In addition, these products, before being allowed to be manufactured in a designated premise, must be evaluated to determine their quality, safety and efficacy through a registration process carried out by a government body called the Drug Control Authority.
The standards applied by the regulatory body in approving the use of a drug in Malaysia are recognised globally through the World Health Organisation. When these approved products are allowed to be manufactured by the manufacturer, the DCA recommends that a set of guideline, known as Good Manufacturing Practices (GMP), be used in the manufacturing of pharmaceuticals.
Under the GMP, four important considerations during the manufacturing process are outlined: the premises must be maintained in a clean condition; the manufacturing operation must be carried out using appropriate equipment which are well maintained; the personnel involved in the manufacturing operation should be qualified and well trained; and proper documentation must be carried out together with an extensive quality control programme.
As fake drugs have not been subjected to the above normal processes to determine their quality, safety or efficacy, it is therefore unwise to assume that they can be safely used. Under these circumstances, these products should be used by consumers as they may affect one's health or many prove to be fatal.
To prevent untoward effects of using such products, consumers should always make sure that they are taking only approved products in any self-medication cases.
If in doubt, further information on the drugs could be obtained from your nearest doctor or pharmacist. In some cases, the manufacturers would normally provide further details on the safety features as well as the physical characteristics of most over-the counter drugs.
