Iran is a large pharmaceutical market in regional terms having a large and fast-growing population of more than 70 million and wide public healthcare coverage. Although Iran has low per capita pharmaceutical consumption (around US$34.7 in 2008 and 40.0 US$ in 2009) compared to other countries in the region, the large size of its population and its under-developed market coupled with the growing aging population will continue to encourage the development of its pharmaceutical market. Basic healthcare reaches about 90% of the rural population and almost the entire urban population. Self-medication is common among the population, creating a sizable OTC drug market.

In 2009, the market topped US$2.8bn showing an increase of almost 20% compared to 2008. In 2013, The market is expected to reach US$4.5bn in value. The government funds about 48% of health expenditure while the private sector and out-of-pocket spending – account for a majority of healthcare costs, private health insurance meets only 2.6% of total expenditure. All Iranians are eligible for community-based preventive public health and limited curative health services which is funded entirely by the national government.

For more information on Iran health insurance system click here.

Regulatory System

Iran has a national drugs list, the Iran Drug List (IDL), which is drafted by the Iran Drug Selection Committee. All prescription and OTC drugs marketed in Iran (with molecule, salt, dosage form and strength specified) must be listed in IDL prior to availability for prescription. A limited volume of unregistered drugs are allowed to be imported through Emergency Pharmaceutical Centers (EPCs) which are dispensed at the responsibility of the prescribing physician. All manufacturing, distribution and imports of medicines are supervised by the General Pharmaceuticals Bureau and require initial approval from the Ministry of Health. For imported products, a local agent is required to register a product in Iran. If the imported drug is already included in the Iran Drug List (IDL), the import is subjected to submission of required documents along with the DMF/CTD (eCTD in future) and the approval of the MOH’s QC laboratories. For drugs not listed on IDL, the manufacturer or importer/local agent has to follow the process of registering the drug in IDL. For detailed information on the process of registration of drugs in Iran, click Behestan e-Docs.

A GMP inspection is required for manufacturing facilities of new and/or unregistered companies. The pricing of pharmaceuticals in Iran is handled by the Pricing Commission. The commission also dispenses subsidies in order to protect the interests of producers and importers while keeping the consumer costs considerably low. Currently, the commission dispenses subsidies only to importers, mainly impacting comparatively hi-tech medicines.

You can access the Iran drug List (IDL and its sub-lists in Behestan Darou Behestan e-Docs page.

To obtain more information on the manufacturing, import and distribution of prescription and OTC products in Iran, visit our partner companies in Behestan Group’s webpage.

Finished Product Importation

Based on the current laws, the importing company must assign a technical supervisor, who is responsible for all technical and formal aspects of registration and drug import and must ensure adherence to good storage practice (GSP) and good distribution practice standards. In the past, all drug imports were undertaken via four state-owned government companies, while distribution within Iran was via six government firms. In more recent years, the rules have been changed and drugs are now also imported through local offices of foreign companies. Furthermore, all state-owned companies that import medicines were required to be privatized or terminate their activities by March 2007 which encourages the privatization of the pharmaceutical supply chain.

You can obtain more information on latest regulations of importation of finished products in Behestan e-Docs

Pharmaceutical Manufacturing

IThere are over 50 pharmaceutical companies operating in Iran. Traditionally, Iranian government policy has supported self-sufficiency, with local production accounting for more than 96% of pharmaceutical consumption in terms of quantity. The Iranian Ministry of Health and Medical Education has also encouraged multinational drug makers to setup manufacturing units in Iran, either independently or in partnership with local companies. In order to help persuade foreign firms to invest, the Ministry of Health and Medical Education has stressed that Iran is an attractive contract manufacturing location, due to its low labour and energy costs. Moreover, high demand for pharmaceutical products in the Middle East – due to population growth, changing disease profiles and growing WTO membership in the region – has led to greater efforts by leading Western multinationals to increase their market share in this region.
The authorities are keen to invest in biotechnology and other leading areas of research, as well as to attract foreign players through contract manufacturing and similar ventures.

You can obtain more information on latest regulations of contract manufacturing at the website of manufacturing partner of Behestan Group – Behestan Tolid – and visiting Behestan Behestan e-Docs.