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History of Afghanistan Food and Drug Authority

The Deputy of Food and Drug, as one of the specialized and key institutions within the framework of the Ministry of Public Health of the Islamic Emirate of Afghanistan, plays a fundamental role in safeguarding public health and in regulating, supervising, and controlling the quality of food, medicines, and health products across the country. With the objective of protecting the lives and health of citizens, this Deputy strives through the formulation and implementation of laws, procedures, policies, standards, and national and international regulations to ensure the availability of safe, effective, and high-quality food and pharmaceutical products in domestic markets.

By overseeing the processes of registration, evaluation, importation, production, distribution, and consumption of medicines and food products, the Deputy of Food and Drug prevents the entry and circulation of substandard, counterfeit, and non-compliant items, thereby contributing to the improvement of the health service delivery system and the enhancement of food and drug safety. Furthermore, in cooperation with national and international institutions, the Deputy takes effective steps toward harmonizing Afghanistan’s food and drug regulatory system with internationally accepted standards.

Overall, as a regulatory and supervisory body, the Deputy of Food and Medicine plays a central role in ensuring public health, strengthening public confidence in domestically produced and imported food and pharmaceutical products, and supporting the sustainable development of the health sector in the country.

The roots of pharmaceutical regulation in Afghanistan date back to 1317 Hijri Shamsi (1938), and over decades of transformation and development, this system has evolved into the current structure of the Deputy of Food and Drug, which is outlined below:

In 1317 (1938), the Pharmacy Enterprise was established for the first time within the framework of the Ministry of Finance and remained active until 1332 (1953).

Subsequently, in 1333 (1954), a small administrative unit named Darmalwaki was established under the then Directorate of Public Health and assumed responsibility for pharmaceutical affairs.

Thereafter, the charter of the Medicine Depot was prepared, and based on it, an institution called the General Medicine Depot of Avicenna Balkhi was established. By setting up several wholesale outlets in the center and provinces of the country, it expanded its scope of activities. Under its umbrella, for the first time, a small pharmaceutical manufacturing factory equipped with two tablet-making machines was established in the Karte-e-Char area of Kabul.

Subsequently, with an allocation of twenty million Afghanis as working capital, this institution emerged as a state-owned commercial enterprise with the following objectives:

  1. Provision of medicines and medical supplies required by government departments;

  2. Importation of medicines and medical equipment for market supply;

  3. Ensuring competition with the private sector to stabilize prices;

  4. Maintaining a reserve stock of medicines for emergency situations.

This institution, officially known as the Directorate of Pharmacy Affairs, simultaneously undertook the regulation of pharmaceutical affairs in the country. Its head was appointed upon the proposal of the Ministry of Public Health and approval of the High Council of Ministers. Technically and professionally, it operated under the Ministry of Public Health, while financially and in terms of reporting on capital and balance, it was accountable to the Ministry of Finance.

Later, on 15 Jadi 1364 (January 1986), a large and modern pharmaceutical factory named the Avicenna Pharmaceutical Institute (API) was established on land located at Qambar Intersection in Kabul City, which had been allocated to the Directorate of Pharmacy Affairs. With the installation and assembly of new machinery, the factory produced approximately 120 types of medicines in various forms (tablets, capsules, syrups, sachets, shampoos, rabies vaccine, etc.), meeting a significant portion of the country’s pharmaceutical needs. It also concluded commercial contracts with 17 foreign pharmaceutical companies from countries including India, Bulgaria, Czechoslovakia, Germany, Yugoslavia, Poland, Turkey, and Russia, from which it procured and imported required medicines and sold them with a specified margin. It was responsible for supplying medicines and health products needed by government departments. Additionally, it established state-owned pharmacies in the center and provinces to supply medicines and health products to the public; these pharmacies, known as state depots, enjoyed a good reputation in society. Moreover, at that time, the Pharmacy Enterprise held a 23.9 percent share in the Hoechst Afghanistan Factory.

During the years 1370 to 1380 (1991–2001), as a result of imposed wars and irreparable losses, the medicine importation and production system of the Pharmacy Enterprise collapsed. In order to preserve professional staff, continue activities in line with government policy, distribute medicines to the public, and safeguard national interests, the enterprise procured required medicines from the domestic pharmaceutical market and redistributed them to those in need.

In 1382 (2003), the process of revitalizing the Pharmacy Enterprise began, similar to other government institutions, and its activities resumed with the limited remaining resources. However, due to the rapid development and expansion of the pharmaceutical market and trade in the country, the enterprise increasingly focused on regulating medicines and health products.

After 1385 (2006), the pharmaceutical administration in Afghanistan underwent continuous transformations. In that year, the country’s pharmaceutical authority, under the name of the General Directorate of Pharmacy Affairs, was separated from the Pharmacy Enterprise, and the enterprise’s activities were limited to importation, production, procurement from the market, distribution, and service delivery through its affiliated pharmacies.

As noted above, the Directorate of Pharmacy Affairs, which was originally a state-owned enterprise, had for many years also managed and led pharmaceutical affairs nationwide. At that time, simple and rudimentary mechanisms were applied, mainly limited to issuing licenses for production and importation and granting market access after quality testing. The dual responsibility of the Directorate—on one hand engaging in the procurement, distribution, and provision of pharmaceutical services on a self-financing, commercial basis, and on the other hand regulating national pharmaceutical affairs—raised concerns that such a position could create conflicts of interest and contradict market-economy policies. Therefore, the separation of the pharmaceutical regulatory authority from the Pharmacy Enterprise was proposed. After designing a new structure and completing legal procedures, a new institution named the General Directorate of Pharmacy Affairs was established for the first time in 1385 (2006), assuming leadership of pharmaceutical management in the country.

At this stage, the structure of the pharmaceutical authority mainly included departments responsible for establishing pharmaceutical service centers; registration and licensing for the production, importation, and market supply of medicines and health products; supervision and inspection of activities related to medicines and health products; formulation of the National Drug Policy and pharmaceutical scientific and technical resources (such as the Afghanistan National Formulary, lists of essential and authorized medicines, formulary lists for health service centers, etc.); short-term professional training for pharmacists; evaluation of medicine use nationwide; and provision of drug information under the Avicenna Pharmaceutical Institute (API). This phase lasted approximately a decade and witnessed significant technical and professional progress in the country’s pharmaceutical sector.

The subsequent transformation in the structure of pharmaceutical administration involved the development of drug regulatory authorities based on the recommendations of the National Drug Policy (1393–1397 / 2014–2018) and the core functional objectives of the pharmaceutical sector, through the separation of regulatory and service components. Accordingly, in 1395 (2016), the National Authority for the Regulation of Medicines and Health Products emerged as a comprehensive and authoritative regulatory body at the national level, while service-delivery components were placed under a new entity called the Directorate of Pharmaceutical Services within the framework of the Ministry of Public Health.

Finally, in 1399 (2020), based on the recommendations of the National Drug Policy and with the aim of better coordination and improvement of drug and food-related affairs, the then government issued a decree to establish an independent Food and Drug Authority. Following the fall of Kabul and the re-establishment of the Islamic Emirate of Afghanistan, the issue of the Food and Drug Authority was once again discussed in cabinet meetings and was approved and retained.

Currently, the Deputy of Food and Drug of the Ministry of Public Health, is responsible for regulatory affairs with a focus on two major sectors: medicines and food.