In a new health alert, the National Institute for Food and Drug Surveillance (Invima) indicated that a product called Yellow Fever Vaccine is being fraudulently marketed, which comes in a one-milliliter presentation.
Currently, the health authority noted, this medicine is being sold as a biological product that can help prevent yellow fever disease, but it does not have the proper permission.
As indicated by Invima, it does not have a sanitary registration issued by that entity and it is not being manufactured or imported by the laboratory that is mentioned on the labels of the specimens.
To this extent, the competent entity added that selling this medicine in Colombia “is illegal” and should not be supplied to any patient.
Likewise, Invima indicated that this vaccine is being distributed in national territory as a “biological product with the name of Laboratorios Delta® as manufacturer, in view of which it is important to clarify that Laboratorios Delta® issues a formal complaint to the institute informing that they have never manufactured, imported and marketed this vaccine in the country, noting that the medicine subject to this alert is not part of its current and historical product portfolio.
According to Invima, the status of this last product is “under renewal”, which does not mean that it cannot be sold in national territory. “It is necessary to specify that the medicines whose sanitary registration is in the process of renewal can continue to be manufactured, imported and marketed; In other words, the validity of the registration is extended until this Institute makes a substantive decision on the renewal process, ”said the health authority in its alert document.
This is the yellow fever vaccine that is being illegally marketed in Colombia, according to Invima. | Photo: Invima
In contrast, the 1 ml Yellow Fever Vaccine is considered fraudulent in light of current regulations. In fact, Invima recalled that to the extent that the product does not have a sanitary registry, it has not gone through the evaluation of the authorities either.
This, in turn, means that officials have not had the opportunity to examine aspects such as its quality, its safety, and its effectiveness in preventing the disease it is supposed to combat.
Aedes albopictus is an epidemiologically important vector for the transmission of many viral pathogens, including yellow fever virus. | Photo: Soumyabrata Roy/NurPhoto
“Additionally, relevant aspects such as its composition (quali-quantitative formula) and storage, transport and distribution conditions are unknown,” Invima stressed.
Likewise, it asserted in its health alert that this is not the first time that it has issued a warning about the risks that these fraudulent products imply for public health. He recalled that they frequently threaten the well-being of consumers and “allude” to benefits and properties that have not been verified by the health authorities.
This, in addition, can imply that “false expectations” are generated among patients, since there is no way to verify the true nature, origin, composition and quality of its effects on health.
Invima has already pointed out on previous occasions that products without a health registration can put the health of patients at risk. | Photo: National Institute for Food and Drug Surveillance
“Citizens are called upon to always verify the product’s health registration number before using it and confirm its authenticity through the following link, selecting the type of product as a group (medication, dietary supplement, etc.) and carrying out the search by product name, sanitary registry or active ingredient”, Invima concluded in its alert.
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2023-08-03 14:33:15
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