- Tous > Quality and Safety: Medicines > Counterfeit Medicines
- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > counterfeit drugs
- Mots-clés > counterfeiting - measures to combat
- Mots-clés > medicines registration
- Mots-clés > MeTA - The Medicines Transparency Alliance
- Mots-clés > quality of medicines
- Mots-clés > registration of pharmaceuticals
- Mots-clés > SSFFC medical products - surveillance and monitoring
- Mots-clés > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2016; 94 pages)
Medicines are made available in all health care systems to address the health problems of the population. It is expected that they conform to national and international standards of quality, efficacy and safety. These attributes have to be maintained at all points of the pharmaceutical supply chain up to the point of care to achieve positive health outcomes. When Spurious/Substandard/Falsely-labelled/Falsified/Counterfeit (SSFFC) pharmaceutical products enter the commercial market, they brought in health, political and economic burden. While the proliferation of SSFFC is a known complex and global issue that transcends national boundaries, it is expected that governments have the capacity to provide technical and regulatory measures to control the entry and distribution of these questionable medicinal products.
The World Health Organization (WHO) defines "Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit (SSFFC) medical products" as medical products that are outside of specifications, which includes intentional, reckless or negligent errors, false packaging, and those intended to deliberately deceive and imitate a genuine product (WHO, n.d.). This definition was further broadened in the Philippine definition of Counterfeit Drugs which included unregistered products with the Philippine Food and Drug Administration, regardless of conformity to quality specifications. The Philippine Republic Act No. 8203, otherwise known as the "Special Law on Counterfeit Drugs," refers to a counterfeit product as a medicine with correct ingredients in wrong amounts, wrong ingredients, without active ingredients, or with sufficient quantity of active ingredient that results in the reduction of the drug’s safety, efficacy, quality, strength or purity. It may be deliberately and fraudulently mislabeled with respect to identity and source or with fake packaging, and can be applied to both branded and generic products (Special Law on Counterfeit Drugs, 1996).