Who is responsible for medicines with carcinogenic ingredients on the BiH market?

(Patria) - The medicines "Ranitidin" and "Ranisan" are being withdrawn from the market preventively in order to protect public health, based on the recommendation of the European Medicines Agency. Shortly thereafter, the Agency for Medicines and Medical Devices of Bosnia and Herzegovina also withdrew the medicine Ranibos from the BiH market, which contains the active substance ranitidine manufactured by Saraca Laboratories Ltd., whose marketing authorization holder is the company Bosnalijek.

"The aforementioned withdrawal procedure is being carried out based on suspicion of a quality defect in the active substance ranitidine manufactured by Saraca Laboratories Ltd., which relates to the presence of a substance called N-nitrosodimethylamine (NDMA)," the Agency for Medicines and Medical Devices announced.

A document from the European Medicines Agency (EMA) expressed suspicion about the potential harmful effects of the detected amount of NDMA impurity on human health, which will be confirmed or refuted by subsequent tests.

The European Medicines Agency, in close cooperation with national medicines agencies, will check all finished medicinal products containing the active substance ranitidine hydrochloride from various manufacturers. However, the question is who in BiH could do this and how effectively.

For years, the Agency for Medicines and Medical Devices has been appealing to the Council of Ministers of BiH. The importance of a control laboratory is invaluable for the entire population of BiH, and the departure of staff due to extremely low salaries has not affected anyone so far.

Ramo Rustemović, president of the Trade Union of the Agency for Medicines, who has been trying for years to warn the authorities about the devastating status of the Agency's employees, notes that, unfortunately, the importance of the Agency's existence is now visible.

“What would have happened without the Control Laboratory, and people are working with reduced capacity, for salaries less than the amount of the phone bill of parliamentary representatives. The problems are evident regarding the labor-legal status of workers, the systematization rulebook which has not been changed for years, and the recruitment of new and qualified people is very slow. People are retiring, moving to other jobs, and recruitment is slow. Not to mention the material status, there is no improvement there,” said Rustemović.

He adds that the Agency reacted and withdrew the medicines because there is a carcinogenic substance.

“We do this automatically, because we are a member of the network of European laboratories (OMC). If nothing else, we did it preventively,” Rustemović added.

The Control Laboratory, which has been part of the network of European laboratories for many years, actively participates in the work of numerous groups of the European Directorate for the Quality of Medicines & HealthCare (EDQM).

“Our citizens can be sure that the quality of the medicines they use has been checked and that it is in accordance with current European standards,” said Aleksandar Zolak, director of the Agency, recently.
So far, no one has commented on possible sanctions and clarifications as to whether Ranisan was withdrawn preventively, whether there were controls, who conducted them and when?

There is clearly a big loophole in the system, the law is clear: "medicines can be on the market provided that they have a marketing authorization in BiH issued by the Agency, that each batch of medicine is produced in accordance with the documentation based on which the valid marketing authorization was issued, and if the quality control of each batch has been carried out in accordance with the provisions of the Law, regulations adopted based on this Law and the valid marketing authorization, that each batch of medicine is marked with the characteristic sign of the Agency, in accordance with this Law and relevant bylaws".

Whether all of the above has been respected will be shown by the inspection findings.