Cambodian wholesalers urgently need anti-counterfeiting guidelines

The Cambodian Department of Drugs and Food (DDF) has found that a significant number of pharmaceutical wholesalers in the country are unsure about the definition of counterfeit medicine and are not adequately informed about the issues surrounding fake drugs.

The regulator is thus calling for the development of guidelines setting out anti-counterfeiting measures, which it says wholesalers urgently need to follow.

The DDF's findings are set out in a report, "Perceptions and practices of pharmaceutical wholesalers surrounding counterfeit medicines in a developing country: a baseline survey", published by BioMed Central Health Services Research on 11 November. It discusses the outcome of a 2009 survey of 62 pharmaceutical wholesalers in Cambodia that was carried out by the DDF in collaboration with Japan's Kanazawa University.

The researchers found, among other things, that a significant number of wholesalers think counterfeits are simply medicines without a Cambodian registration. A majority of the wholesalers interviewed for the study defined counterfeit medicines as such, or as products that were "fraudulently manufactured."  

Indeed, 66 per cent of the wholesalers said they used registration as a basis for procurement decisions and 71 per cent said they checked for a Cambodian registration upon receipt of a consignment.

According to 81 per cent of the respondents, the condition of the medicines themselves was the most telling aspect of a shipment's integrity, whereas only around 10 per cent of wholesalers checked a shipment's certificate of analysis - even though all pharmaceutical consignments are required to have one.

Moreover, although the DDF does not allow wholesalers to import or procure medicines without proper packaging, nor are they allowed to repack medicines, only 57 per cent of respondents said they checked that the packaging was intact upon receipt, and 55 per cent said they repacked medicines in ordinary, commercially purchased paper or plastic packaging.

The researchers suggest that this may be because of wholesaler-supplier trust, which plays a significant role in procurement decisions.

As for reporting counterfeit medicines, the survey found that a large number of wholesalers were not aware of the regulations.

Only 72 per cent of respondents said they would report the receipt of counterfeits to the regulatory authority as required; 28 per cent said they would either send the shipment back to its source or separate and discard the medicine without informing the authorities.