GPHC bent on enforcing lax or outdated requirements

first_imgDear Editor,In an article “Government cracks down on illegal medicine” published on March 22, 2019, in the Guyana Chronicle, Director of the Government Analyst Food and Drug Department, Marlon Cole said that “it is more than likely that Guyana has a higher rate of substandard and falsified medical products on its market”.The article went on to say “that several distributors of pharmaceuticals and other medical supplies have not acquired marketing authorisation as required by law, and as such, are engaging in the sale and distribution of pharmaceuticals that are not approved by the Food and Drug Department”. Mr Cole noted that efforts to aggressively enforce legislation mandating distributors to acquire marketing authorisation and drug registration have commenced since 2014, however, resistance to these efforts have continued.It is interesting to note that The Georgetown Public Hospital Corporation’s Procurement of Pharmaceutical 2019 Evaluation Criteria, at questions 19 and 20, exempt foreign businesses at the time of bidding from providing a valid import licence and valid marketing authorisations, provisions which directly contradict and undermine the efforts of the Government’s Food and Drug Administration. The effects of this are ultimately felt by the consumers since this presents a direct route to unauthorised entry of drugs not subject to quality inspection by the authority.Further, this places local importers and manufacturers at a disadvantage since they are required to invest time and resources into acquiring the import licence as well as preparing and sending off technical and voluminous documentation as well as products for marketing authorisation. In the absence of evidence supplied by distributors that the product is certified to be sold in Europe and North America, and through CARPHA, Mexico, Cuba, Chile, Argentina, Brazil and Columbia, there are obvious questions about their quality.It is disappointing that throughout the public health arm of the Government that such a wide disconnect exists in an area which is critical to ensuring the public’s safety. While the GA-FDD has undertaken significant investment in equipping themselves to raise the standard of drugs sold on the local market and ensure importers’ compliance with the law, the GPHC seems bent on enforcing lax or outdated requirements which, in effect, achieve the complete opposite and are also in violation of the law, as Mr Cole explained.Sincerely,Vishal Sukhailast_img read more

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