Conclusion
Due to recent developments in economical environment in Iran, it is expected that Iran pharmaceutical sector will expand both in value and volume. In recent decade some private companies also emerged in Iran pharmaceutical market. Emerging of newly established small knowledge based companies might pose both risks and opportunities for Iran pharmaceutical market. These new companies have fragile financial turn over and recent government policies of subsidy reforms which resulted to the hike in energy costs and hard currency floating policy might put some pressure on local manufacturing in general including the new high tech companies.
Despite presence of local pharmaceutical companies, due to fairly advanced health care system of Iran, the country needs to import expensive novel medicines to satisfy patients’ demands. Iran pharmaceutical market is considered as a highly regulated market. As related to the national pharmaceutical market generally the IFDA makes all strategic decisions and monitor implementation of the regulations.
Although in an attempt to improve transparency of procedures, in recent years IFDA has published its policies and guidelines, lack of procedural transparency, lack of consistency and non binding to the regulations are major weaknesses of IFDA. In its current administration system in IFDA offices, different pharmaceutical companies might receive different responses for similar requests. Therefore in some cases IFDA may decide based on “case by case” approach. Lack of efficient control on promotional activities of pharmaceutical companies is also a derive for inducing demands in Iran market. Despite presence of a governing guideline in IFDA for regulation of promotional activities of pharmaceutical companies, relax implementation of the guideline provided an almost absolute liberty for companies on their relations and sometimes misconduct with prescribers and physicians in order to bring their brands into their prescriptions. There is a danger that lack of transparency and uncertainty in the regulatory requirements for the registration of the medicines will encourage manufacturers to ignore ethical aspects of promotion. This may cause irrational use of medicines which could impose extra expenses both in financial and medical aspects on patients and the national health system.
Competing interests:
None
