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CHAPTER 2 EVOLUTION OF FOOD AND DRUG REGULATION IN NIGERIA Throughout history, society has been concerned with the quality of drugs, food and other health sensitive products. This prompted several societies to undertake some kind of regulation for the production and use of such products. For instance, in ancient Egypt, during 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. During the first century AD, methods were also designed to counteract the problem of drug adulteration. The origin of the United States Food and Drug Administration (USFDA) dates back to June 1906, when President Teddy Roosevelt signed the Food and Drugs Act and entrusted the implementation of this law to the Bureau of Chemistry of the US Department of Agriculture. The Bureau, which is the oldest US consumer protection office, eventually became the Food and Drug Administration (FDA), an Agency of the Department of Health and Human Services. The FDA was further strengthened by the 1938 Federal Food, Drug and Cosmetic Act, which became necessary after the Sulfanilamide elixir tragedy. Since then, other countries, at various times, have followed the example of the USA to establish their own drug regulatory agencies. Historical Development of Food and Drug Regulation in Nigeria The regulation and control of food and drugs in Nigeria has a chequered and beleaguered history. The first known legislation in this area was the 1891 Sale of Drug Ordinance. This law was made to apply to the then colony of Lagos. It was later repealed and re–enacted in 1902. The ordinance was subsequently extended to the Colony and Protectorate of Southern and Northern Nigeria in 1907. A nationwide Drugs and Poisons Ordinance was promulgated in 1915, following the amalgamation of Northern and Southern Nigeria in 1914. This statute went through some amendments, repeals and re-enactments in 1922, 1927 and 1936. The Pharmacy Ordinance of 1945 repealed the 1936 legislation. In 1964, it was renamed the 7 8 The War Against Counterfeit Medicine Poisons and Pharmacy Act. The main thrust of this Act was to ensure the controlled sale and use of certain drugs and poisons. 7 In the case of food regulation, the first known legislation was the Food Adulteration Ordinance of 1903. It applied to the then Colony of Lagos. With the 1914 amalgamation, the 1903 law was repealed by the Sale of Food Ordinance of 1917, which took effect in 1954 as regional legislation, due to the adoption of a federal structure for the country. This law was replaced with the Food and Drug Act of 1974. As in the case of drugs and poisons, the policy thrust was geared towards prohibition, as against proper regulation. InitialAttempt at an Institutional Framework The first attempt at providing a modern institutional framework for the regulation of food and drugs in Nigeria was in 1974, with the Food and Drugs Decree (now Act). This was to regulate the manufacture, sale and advertisement of food, drugs, cosmetics and medical devices. With the promulgation of the Act, the Directorate of Food and Drug Administration and Control (FDAC) was established in the Federal Ministry of Health, to enforce the provisions of the legislation. In FDAC, there were quality control laboratories, provision for inspection and enforcement, and a fairly well-equipped drug-manufacturing laboratory. However, there was no provision for product registration, thereby making drug importation and manufacturing a free-for-all affair. Civil service bureaucracy, corruption, political instability and a host of other lapses hindered the activities of FDAC. To remove the bottlenecks in FDAC, and ensure effectiveness, NAFDAC was established in 1993 by the then Nigerian Head of State, General Ibrahim Badamasi Babangida. The Minister of Health at the time was the late Prof. Olikoye Ransome-Kuti. ...

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