Alims ALiMS Vlada Republike Srbije
ALiMS
Substandard and counterfeit drugs
New global manner and conditions of free trade led to the overall increase of manufacture of all medicinal products on the world market, leading to more favourable conditions for the production of counterfeit drugs.

Counterfeit drugs are difficult to discover. They can escape all controls, especially due not only to increasing globalization and free trade, but also to the enlarged number of countries which manufacture and export medicinal products, active substances and excipients. Moreover, modern technology accessible to everyone facilitates production of counterfeit practically identical to the originals. In most cases this refers to medicinal products as well. Substandard drug is an original product not in compliance with the set quality specification, which results in an inefficient medicinal product and endangers a patient. Substandard drug may be a result of neglect, human error, insufficient human and financial resources of counterfeit.

Counterfeit drugs represent a part of wider phenomena of substandard medicinal products. They developed as a result of deliberate and forged labeling of their identity and/or origin.

Protected generic products can also be counterfeited, and a counterfeit drug may be a product containing:

  • Correct ingredients
  • Faulty ingredients
  • Without active substances
  • With insufficient quantities of active substances or a product packed in a fake packaging.
The Serbian Agency for Medicinal Products and Medical Devices has a task to provide the citizens with efficient, safe and good-quality medicinal products, promote the use and monitor optimally the marketing thereof.

In order to protect citizens from using substandard and poor-quality medicinal products, as well as counterfeit drugs, and in accordance with the recommendations of reporting on adverse effects of medicinal products, the Serbian Agency for Medicinal Products and Medical Devices collects the reports on substandard and counterfeit drugs.

For that matter, health-care workers from all fields of practice should:
  • Respect the principles of Good Pharmacy Practice, Good Manufacture Practice GMP,....
  • purchase medicinal products only from reliable sources, paying thereby attention to the storage conditions they were in before the purchase and in the supply chain
  • warn about the differences in the quality of packing, labeling or instructions for use, as well as in physical appearance of medicinal products,
  • report to the competent state authorities every case of suspicion, either due to the absence of expected therapeutic effect or for any other reason, that the counterfeit was offered or submitted and to isolate and not dispense all medicinal products under suspicion of being counterfeit and to cooperate with investigators in order to trace the source of supply.
 Reporting counterfeit drugs:  Prijava lažnih lekova  Prijava lažnih lekova

Send a completed report as an attachment to E-mail address: nci@alims.gov.rs