All the interest groups brought together in countries implementing MeTA sign up to disclosure of data on the quality and registration status of medicines.

Poor Quality Medicines1

Poor quality medicines are a health hazard because they may contain toxic substances that have been unintentionally added or they may  contain only a  little or none of the claimed active ingredient, so will not have the intended therapeutic effect. Not only can medicines of poor quality medicines damage health, but they are a waste of money for both governments, patients and consumers.

Most countries will only accept the importation and sale of medicines that have been manufactured to internationally recognised Good Manufacturing Practice (GMP). Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.

GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention (PIC).

Spurious/falsely-labelled/falsified/counterfeit medicines2

Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines should never be confused with substandard medicines. With substandard medicines there is no criminal intent, but in the case of SFFC there must always be criminal intent.

The problem of SFFCF medicines was first addressed at the international level in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO, together with other international and nongovernmental organizations, should study the feasibility of setting up a clearing house to collect data and to inform governments about the nature and extent of counterfeiting.

In 1988 the World Health Assembly adopted resolution WHA41.16 which requested the Director-General of WHO to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations. Given the rapid spread of counterfeit drugs in many national distribution channels, the World Health Assembly in 1994 adopted resolution WHA47.13. This requested the Director-General of WHO to assist Member States in their efforts to ensure that available medicines were of good quality, and in combating the use of counterfeit drugs.


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Medicine tablets