National and international regulatory and legislative approach governing drug safety: confronting drug counterfeiting in developing countries

Document Type : Original Article


1 PhD studentof International Law, Departement of International Law, Karaj Branch, Islamic Azad University, Karaj, Iran.

2 Assistant Professor, Departement of International Law, Karaj Branch, Islamic Azad University, Karaj, Iran.

3 Assistant Professor,Departement of private Law, Karaj Branch, Islamic Azad University, Karaj, Iran.



In the ecosystem of the health system, ensuring quality control, safety and effectiveness of drugs is very sensitive and necessary for people's health. After the Covid-19 pandemic, fake vaccine drugs have been circulating and seriously threatening public health around the world. This situation needs to pay more attention to the quality and more effective safety of medicine with the aim of combating drug counterfeiting. The current measures are not effective and sufficient to deal with all the problems associated with counterfeit drugs. In this article, by examining the importance of drug safety monitoring, it was observed that developing countries do not have adequate, standardized and integrated international monitoring regulations to evaluate the quality and safety of drugs. Finally, due to the lack of control over the supply chain, drugs will easily enter the flow of forgery and fraud. The existence of strong monitoring institutions in accordance with the standards of national or international laws, as well as the application of deterrent punishments in each of the stages of the drug production, distribution and delivery cycle, is required. This research is based on an analytical-descriptive method and on the basis of authentic library documents and sources. The theoretical framework of the research is rights based on justice.


Main Subjects

Articles in Press, Accepted Manuscript
Available Online from 23 October 2023
  • Receive Date: 08 January 2023
  • Revise Date: 29 August 2023
  • Accept Date: 23 October 2023