The mobile laboratory: a new concept in medicines surveillance.(Safety of Medicines)

According to the World Health Organization (WHO), about 6 to 10% of medicines worldwide are counterfeit; a market worth 32 billion US dollars in annual sales. The phenomenon has grown in recent years due to methods of counterfeiting becoming more sophisticated and to an increase in the quantity of counterfeit drugs crossing borders. Trade in fake medicines mainly occurs in developing countries, but counterfeiting is now also increasingly becoming a problem in developed countries.

In response to the challenge presented by the public health crisis caused by a global increase in counterfeit drugs, WHO has launched a special taskforce, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The main purpose of IMPACT is to build a coordinated network across and between countries in order to halt the production, trading and sale of fake medicines around the world. IMPACT is a partnership comprising all the major anti-counterfeiting players, including international organizations, nongovernmental organizations, enforcement agencies, pharmaceutical manufacturers associations and drug regulatory authorities.

As elsewhere in the world, fake and substandard drugs in China are driven by huge profits, and have consequently become quite sophisticated. In order to crack down on the manufacturing and marketing of counterfeit pharmaceutical products, the Chinese Government has implemented a number of drug surveillance programs. In China, fake and substandard drugs mainly appear at the retail level in the supply chain, and therefore these programmes generally require samples to be collected from the market and analysed in quality control laboratories at the provincial or district level.

Common methods used on-site by local authorities include basic tests, such as appearance, colour and weight, identification by thin-layer chromatography (TLC), and basic functional group tests using wet chemical analysis techniques. Samples suspected of being counterfeit are then sent to quality control laboratories at the district level for analysis using more specific methods such as high performance liquid chromatography (HPLC). Such programmes have their merits, but are not very effective in detecting the more sophisticated high technology counterfeit products.

To reinforce surveillance, medicines are also routinely sampled from the market and sent to district laboratories for testing, but this can be costly. Moreover, counterfeit drugs are often deliberately made to pass tests defined in the Chinese Pharmacopoeia to avoid being caught by the Chinese State Food and Drug Administration (SFDA) surveillance programme. There is therefore a demand to improve on-site analysis so that more sophisticated counterfeits can be reliably detected, and resources at the district level can be better utilized. Reliable on-site analysis will also allow resources to be efficiently targeted at those cases where law enforcement already has evidence that counterfeit products are being distributed.

[ILLUSTRATION OMITTED]

Objectives and development of the mobile laboratories