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WHO blames inadequate legal framework, weak administrative measures for rise of counterfeit drugs

Joseph Alexander, New DelhiMonday, January 19, 2009, 08:00 Hrs  [IST]

The Word Health Organisation (WHO) has blamed it on the governments' unwillingness to recognise the gravity of the problem, inadequate legal framework, insufficient sanctions, weak administrative measures and ineffective collaboration among the member countries for the rise of counterfeit medical products. In a paper by the WHO secretariat ahead of the forthcoming executive board meeting later this month on the subject, the agency said the ineffective control of manufacturing, importation and distribution of medical products, ineffective collaboration among the authorities and institutions involved in regulation, control, investigation and prosecution and national drug policies that prioritized economic over public health aspects of medicine manufactured contributed the rise of counterfeit drugs. It urged the member states to establish and enforce legislation and regulations that prevent counterfeit medical products from being manufactured, exported, imported or traded in international transactions and the regulated distribution system. It also called for effective mechanisms of coordination and collaboration among relevant authorities and aimed at international cooperation and exchange of information. The forthcoming meeting will assess the problems encountered in the implementation of the work of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and recommend steps for further action. "Counterfeit medical products have been detected in most member states and in all regions. Examples have involved widely-used medicines such as atorvastatin or paracetamol, limited-use medicines such as growth hormone, paclitaxel and filgastrim, other kinds of medicines such as sildenafil and tadlafil as well as medical devices such as contact lenses, condoms, surgical mesh and strips used by diabetic patients to monitor own blood glucose concentrations. Counterfeiting has affected both expensive and cheap products and generic and branded ones. Counterfeit products appear in community pharmacies, hospitals and other less-regulated settings, the paper said. It said as per the 2007 figures, the cases of counterfeiting has gone by 20 per cent over the previous year and went up ten fold from the year of 2000. "Although the medicines regulatory authorities of most member states are aware of the problem, obtaining information is difficult and published reports can sometimes be misleading even when issued by reputed sources. The most important limitations of the available information are that often no distinction is made between patent violations, patent or trademark disputes, copyright violations and actual counterfeiting and that information about the role of the source country (eg, in which counterfeit products are manufactured or repacked or through with they transit) is often not available," the paper said.

 
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