Issues with generic drugs in Saudi Arabia.

“Generic drugs” were first introduced in 1938 in the USA. Since a definition for a “generic drug” is not specified in either the law or regulations, a working definition that has been adopted is “a drug product that compares to the pioneer, reference drug product in dosage form, strength, route of administration, quality and performance characteristics, and in intended use”.1 Although generic drugs have been available in many countries for a long time, they are, relatively speaking, a new addition to the list of medications in Saudi Arabia, where they have been welcomed by both health professionals and patients. The local and regional drug industry is mainly generic in nature until the day they start manufacturing their own, newly developed drugs. Hence the acceptance of these products by professionals, institutions, health authorities and consumers means the survival of the local pharmaceutical industry. In addition, regulating the licensing of generic drugs represents a driving force for the local pharmaceutical industry to produce pharmaceuticals of high quality to justify their licensing by health authorities both locally and worldwide.2

Generic drugs are considered a mean of cost containment in health institutions and by the government. Usually generic drugs are promoted as effective and less costly alternatives to brand drugs, which means the market for generic drugs has flourished. Although many generic drugs fulfill these expectations, some do not. The majority of complaints about generic drugs are related to their being either less effective or more toxic, with decreased efficacy being the most emphasized characteristic.

In addition, there are several ethical implications with generic drugs. For example, ethical issues related to “inexpensive” generic drugs for the treatment of AIDS in countries where governments and people cannot afford drugs produced by innovative companies have been raised at international scientific and political conferences.

For generic drugs to find good market share, they have to be accepted by patients and consumers. Acceptance includes the name, packaging, taste, a reputation for being effective and having a reasonable cost compared to the innovative company drug. Few studies have explored these issues. The current study by Al Haidari and Gebran represents one step in the process of evaluating generic drugs. Most of the literature addresses bioequivalence/bioavailability issues. As important as it is, these studies provide no more than surrogate evidence of the efficacy of generics compared to the innovative company’s product. These studies almost always investigate the pharmacokinetics of the drug and rarely address the more important aspect of pharmacodynamics, considered to be at least as important as the blood levels of drugs. There are several difficulties that may hamper pharmacodynamics studies, rendering them very difficult if not impossible to conduct due to economic, logistical and time constraints.

The study published in this issue of the Annals of the Saudi Medicine highlights the importance of investigating generic drugs from different angles and requires health authorities to look at generics in a more comprehensive way. It also requires the authorities to assign people who are responsible for the licensing of such products to the updating of the product approved labeling by keeping abreast of the literature and changes in drug indications, dosing and/or adverse effects.

In summary, for a drug to be a quality generic it must be as effective as the brand drug, accepted by patients, offer some real cost saving and have the same indications, dosing, adverse effects and patient information as the innovative brand drugs. An important regulatory issue is whether it is good to have so many versions of the same chemical entity and whether this should be regulated. A new section in the regulations dealing with generic drugs may help enforce the requirements dictated on manufacturers.