Since time immemorial humanity has been concerned with the quality of drugs, and throughout all this time societies have undertaken some kind of regulation of the use of medicines, and of those who prescribe and dispense them. For instance, in ancient Egypt in the first century BC physicians were required to administer their drugs in accordance with written laws. If they failed to do so in any respect and the patient died, they were tried and punished.² Methods were also laid down as far back as the first century AD to counteract the problem of adulteration.³ During medieval times in Muslim countries, the muhtasib made frequent inspections and supervised the preparation of medicines. ^2,3,4,5

In Europe, between the eleventh and twelfth centuries, several laws relating to medicine and apothecaries were passed. Doctors were forbidden to keep apothecaries or to enter into business with apothecaries, and apothecaries were strictly controlled and obliged to prepare reliable drugs of good quality.²

Later, in the United Kingdom, the Apothecary Wares, Drugs and Stuffs Act, passed in 1540, empowered physicians to inspect the premises of apothecaries for drugs that were:

“... defective, corrupted and not meet nor convenient to be ministered in any medicines for the health of man’s body...”.^1,5

Later still, in the nineteenth century, during a period of rapid industrialization, the role of apothecaries was taken over by industry. This increased the number of drugs on the market, as well as trade in drugs. At the same time, gross adulteration of drugs occurred, and ultimately led to social pressure for drug quality control. Many countries responded by introducing laws establishing standards for drags and prohibiting adulteration.^6,7

Thereafter, research to develop new drugs increased tremendously and made many major advances. Concurrently, pharmaceutical production and supply systems worldwide underwent major changes, resulting in a proliferation of products as well as of manufacturers and suppliers, and contributing to the increasingly serious problem of counterfeit and substandard pharmaceutical products on the international market. Additionally, drugs with serious side-effects started to appear on the international market and a number of incidents associated with their consumption occurred.^2,5,6,7 These circumstances catalysed the revision of drug legislation and the strengthening of drug control in many countries. For example, in the early 1960s, an outbreak of phocomelia, involving gross fetal deformities, was linked to the use in pregnancy of the new drug thalidomide. The realization of the injury that it had caused provided the greatest single impulse to the development of new drug legislation in Europe and elsewhere.⁵

Today, although the structure, scope and practices of drug regulation may differ from country to country, the development, production, storage, distribution, supply and sale of drugs are subject to government intervention in every industrialized country, and in much of the developing world.