Thailand Food And Drug Administration

Introduction

The Drug Control Division has set a vision as an institute with reliability and good reputation in consumer protection. The public is thus assured of accessibility to safe and efficacious marketed pharmaceutical products of standard quality, to reliable and adequate information, and to advance technology. The Division promotes the production capacity of local pharmaceutical industries to the extent that they are able to export medicines of standard quality.

The Division carries out its mission in consultation or cooperation with experts in science, medicine, pharmacy and public health, consumers, manufacturers, importers, distributors and retailers of drugs. It works closely with several other organizations (e.g. universities, industries, hospitals, health-care professional groups, consumer groups, other relevant agencies and foreign governments) in the drug development and review processes.

Historical Background

The regulation of pharmaceutical products in Thailand began in 1909 when the adulteration of drug products and narcotic substances was prohibited. There had been practically no control of drugs before 1909. The first legislation promulgated in 1922 was the Harmful and Habit-forming Drugs Act. However, the duties for manufacturing and dispensing medicines were not assigned to pharmacists until 1929.

The manufacture and sale of alcoholic preparations containing indigenous medicinal herbs became more and more extensive until the widespread use caught the attention of the Medical Association of Thailand. The problems eventually led to the promulgation of the Sales of Drugs Act in B.E. 2479 (1936). The first legislative measure implemented in the field of pharmaceutical regulation dealt only with sale practices regardless of formulas or ingredients. At that time, neither manufacturers nor importers/retailers paid much attention or assumed their responsibilities to quality and safety of their drug products.

The improvement in pharmaceutical regulation in Thailand was observed after the Sales of Drugs Act of B.E. 2493 (1950) came into force in 1951. The Act encompassed many aspects of drug control other than the control of sale practices. For instance, the control of production and registration of pharmaceutical products as well as the standard requirements of drug quality were included in the Act.

The Act eliminated substandard, deteriorated and adulterated drug products on the local market. Consequently, manufacturing standards of local pharmaceutical firms and dispensaries were upgraded to some extent. The Act was applicable not only to production, importation and sale practices, but also to product registration, labeling requirements and pharmaceutical advertisement control. A few amendments to the Sales of Drugs Act were undertaken from time to time in order to make the law up to date and to cope with changing circumstances in the pharmaceutical business.

After several years of endeavor, the Drug Act of B.E. 2510 (1967) was promulgated to supersede the 1950 Sales of Drugs Act. The 1967 Drug Act covering substantial aspects in drug regulation was enforced for almost two decades. There were four amendments to the Act to cope with the growing numbers of pharmaceutical manufacturers and changing situations until the enactment of the Drug Act of B.E. 2530 (1987), which has major features as follows:

1. Medicines are classified into two major groups: modern and traditional drugs .

Modern Drugs are further divided into four categories, namely 1) household remedies whose sales require no licence; 2) ready-packed drugs that can be sold in drugstores by nurses or other medical professionals; 3) dangerous drugs; and 4) specially controlled drugs. Dangerous drugs can be bought without a prescription but must be dispensed by pharmacists. Drugs which may possess a potentially harmful effect on health, if misused, will be listed in the last category whose sales require a prescription.

Traditional drugs are those intended to be used in indigenous or traditional medical care as monographed in the official pharmacopoeia of traditional medicines or those declared by the Minister of Public Health as traditional medicines or those permitted to be registered as traditional medicines. The control and registration of drugs in this group are less stringent than those for modern drugs.

2. The Ministry of Public Health is authorized to publish in the Government Gazette a list of specially-controlled products, a list of dangerous drugs as well as the lists of particular drugs requiring additional labeling (e.g. expiration date, warning, etc.)

3. Licensing for manufacture, importation and sale of pharmaceutical products is required by law. Applications for licences are to be conducted in accordance with the rules, measures and conditions prescribed in the Ministerial Regulations.

4. Duties of licensees and pharmacists at the place of production, importation or sale are also described. For instance, a licensee who manufactures modern drugs must have finished products of each batch analyzed for quantities of their active constituents before the products are released to the market.

5. Licensees must register their products before manufacture or importation. Details of the products and their formulas, as being registered, cannot be altered without prior approval or permission from the authorities.

6. The Minister of Public Health is empowered to either suspend or revoke the licence from violating or non-compliance licensees.

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