Counterfeit drugs can not only kill those who consume them, but they can also cost quite a fortune to the pharmaceutical industry. However, alertness and prudent action on the part of those who deal in pharmaceutical drugs
such as importers, wholesalers and retailers can prevent supplies of counterfeit drugs from reaching the patients.Impact of Counterfeit Medicines
According to the US based Center for Medicines counterfeit drug sales are expected to reach US$ 75billion
worldwide in 2010, which would be an increase of over 90% from 2005.
In terms of human cost, examples of instances abound. During, the 1995 epidemic of meningitis Niger in 1995, more than 50 000 people were inoculated with counterfeit vaccines
causing 2500 fatalities. A study by Wellcome Trust in South-East Asia disclosed that 38% of 104 anti-infective drugs
(for malaria) stocked in pharmacies didn't have any active ingredients.
The problem of counterfeit drugs is widespread and can only be dealt with effectively, by concerted efforts of all agencies (industry, suppliers, retailers, patients) involved in the business of pharmaceuticals including governments. Following are the guidelines laid down by the World Health Organization for importers, wholesalers and retailers to combat counterfeit drugs:Importers
- Ensure that the drugs which the import are being manufactured legitimately in the countries of manufacture.
- Establish and maintain necessary confidence in the sources of the drugs which they import, and remain satisfied with the integrity and authenticity of the drugs which they import and sell.
- Be aware of and take into account any security arrangements (such as special printing) used in the country of purchase.
- Establish and maintain an audit trail of the imported drugs back to the original manufacturer and wholesaler.
- Obtain certificates for imported drugs that comply with the WHO certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce, whenever available.
- Conduct visual inspection and other analytical checking procedures on the drugs they import to assure themselves to of their legitimacy.
- Maintain records of supplies to wholesale distributors to facilitate recall in the event of counterfeit drugs being detected among their own stocks.
Wholesalers and Retailers
- Report all relevant details of any detected counterfeit drugs to the DRA.
- Purchase drugs from legitimate sources only.
- Avoid purchasing, selling or supplying any drug suspected of being counterfeit or of which the quality, efficacy or safety are in any way in doubt.
- Carry out visual inspection and other non-analytical methods of checking the quality of drugs, including checks on the quality of the labeling and packaging materials, and the name and address of the of the manufacturer.
- Maintain and audit trail of the drugs they purchase.
- In the case of wholesalers, maintain and audit trail of drugs sold to permit the recall of any counterfeit drugs detected, where necessary.
- Employ suitably qualified persons, preferably pharmacists, to fill supervisory and managerial posts in drug procurement.
- Report to the national DRA any suspected counterfeit drugs in the national distribution channels; the products concerned should be withheld from supply.
All in all, if wholesalers and importers maintain their own systems of checks intact, even if counterfeit supplies permeate through the security systems of other agencies, they would be apprehended at the importer's or wholesaler's level.