Our country amended the Law on Medicines and Medical Devices in June of the previous year. The reason for this amendment was to address the issue of low-quality medicines that are being pushed into the market at inflated prices, and to introduce higher-quality products while promoting domestic production, thereby regulating imports. In particular, the law highlights the policy of the state regarding medicines and medical devices as an integral part of Mongolia’s national security. The population and health organizations shall be consistently supplied with quality, safe, and therapeutically effective medicines and medical devices. The domestic production of medicines and medical devices that can replace imports will be developed, and exports will be promoted. In doing so, the government will exercise strict control and regulation, ensuring that prices and other information are transparent.
However, the policies of the Ministry of Health and the initiatives of the Minister of Health, along with the functions of the Department of Control and Regulation of Medical Devices (DCRMD) have all contradicted the law. In specific, the Minister of Health, T.Munkhsaikhan, has become a “dealer” of medicines, exploiting the few provisions of the newly amended law. Particularly, the law allows for the urgent registration and importation of medicines that are already registered in countries with strict regulations, and their use in treatment, provided they meet international quality standards.
But currently, there is no shortage of medicines in our country. The import of medicines continues to grow, and their prices are skyrocketing. According to statistics, Mongolians import and consume medicines worth over 550 to 600 billion MNT annually. As a result, the market is flooded with low-quality, counterfeit, and overpriced medicines. In other words, there is no immediate need to urgently import, register, and push these medicines into the market.
Single-source medicines procurement offers no quality guarantee
Since December of 2024, the direct sale of medicines from a single source has been flourishing in Mongolia. T.Munkhsaikhan, explained this by stating that the government has started purchasing medicines from a single source to improve the quality and safety of medicines and stabilize the prices of drugs used to treat commonly occurring diseases. While it may be beneficial for us to push out medicines that are produced in different countries with varying prices and services from the market and instead buy them from one single source, this operation should comply with laws, regulations, and be subject to strict control and supervision.
However, the question still remains whether every medicine purchased from a single source can be of high quality and safe, as no one has yet been able to provide a guarantee for the quality of medicines supplied to health organizations or provided to citizens at discounted prices.
Currently, 3,899 types of medicines from 745 manufacturers across 56 countries are registered nationwide. About 80 percent of these are imports. According to the Minister of Health, 63 percent of imported medicines do not meet quality standards. Therefore, he claims that the medicines being imported now are from countries with strict regulatory frameworks, and thus are guaranteed to be of high quality. This explanation seems convincing to the Mongolian public, who lack a laboratory to analyze the contents, effects, and authenticity of medicines. In other words, the Ministry of Health and DCTMD are offering only the “guarantee” that these medicines are “produced in countries with proper regulations”.
Medicines are special products, and if their quality and safety are not ensured, it would be no different from poisoning the public with harmful chemicals. In 2023 alone, Mongolia imported medicines worth 528.2 billion MNT from 51 countries including Belarus, Germany, Hungary, India, Indonesia, Russia, Slovenia, and South Korea. Therefore, in an effort to reduce the number of importers, the government has started purchasing multiple types of medicines from a single country. The minister has also stated that if necessary, new medicines registered in countries with strict regulations will be supplied to the market directly through an expedited trust procedure.
But why are the minister and other officials so eager to import medicines? Previously, it took about a year for new medicines to undergo research, testing, and analysis before being registered and introduced into the market in each country. Now, the Minister of Health has been making unilateral decisions and engaging in negotiations with manufacturers over prices as if they are putting on a “show”.
As part of the direct purchase of medicines from a single source, Mongolia has started importing 18 different types of medicines from five manufacturers in South Korea for the treatment of cancer, heart disease, diabetes, digestive disorders, and conditions related to men’s health and endocrinology. Health insurance has provided discounts ranging from 30 to 70 percent for these medicines. Additionally, medicines from Switzerland’s “Roche” factory for cancer treatment have been received and even launched. T.Munkhsaikhan has also announced that negotiations are underway to import over 20 different types of chemotherapy drugs from South Korea. Five of these drugs have already been imported.
This year, the Health Insurance Fund Budget will spend 135 billion MNT on discounted medicines. However, for the medicines imported through the direct purchase mechanism from a single source, about 10 billion MNT has already been spent in the first quarter. Meanwhile, citizens are waiting in line to buy about 600 types of medicines that are included in the essential medicines list, but are not available at discounted prices. It seems that the Minister and other officials do not understand the suffering caused by poverty in the country, as they continue to promote and advertise medicines from a single source without considering the real needs of the people.
Exploiting legal loopholes to ‘trade’ drug quality and safety
It is both troubling and perplexing that DCTMD has remained entirely silent and inactive regarding this critical issue. For months, they have acted as if deaf and blind, seemingly oblivious to the unfolding concerns.
Recently, Member of Parliament J.Chinburen publicly addressed Minister of Health T.Munkhsaikhan, criticizing his interference in the government-approved process of drug procurement. He stated that officials from DCTMD were operating in full compliance with the public procurement law and Government Resolution No. 42. “They had even initiated cooperation and negotiations with UN agencies to procure essential medicines through proper channels,” J.Chinburen said. “But you, T.Munkhsaikhan, abruptly halted these efforts. Instead, you proceeded to sign direct contracts with foreign pharmaceutical manufacturers, purchasing a wide range of medicines without any competitive bidding, without even conducting price comparisons.”
He added, “A member of the Cabinet should not be personally negotiating with suppliers or entering into agreements—this is a blatant conflict of interest.” The MP also stated, “Patients are now desperately searching for those high-quality, effective cancer drugs that were previously brought in at nearly half the price.”
Despite such serious accusations, T.Munkhsaikhan appeared entirely unfazed. On the contrary, he has intensified the promotion of drugs sourced from a single supplier, broadening the range and increasing imports with even greater zeal.
Meanwhile, the very agency tasked with safeguarding the public—ensuring access to safe, effective, and quality-assured medicines and medical equipment—has remained inert. Has DCTMD been silenced by fear of the Minister? Their failure to fulfill their regulatory responsibilities is deeply concerning.
Attempts to obtain clarification from the department regarding their role in the procurement of these single-source drugs—particularly how they are monitoring safety and quality—have gone unanswered. Reports suggest that their top officials are frequently summoned to the Ministry of Health for endless meetings, seemingly under constant pressure. However, DCTMD is not an appendage of the Ministry. It is a government agency with a mandate to operate independently and implement state policies, not to bow to ministerial will.
It is time for the department to abandon its passive stance and assert its authority. Rather than capitulating to the whims of a powerful minister, the agency must independently organize the drug procurement process, ensure full transparency, and deliver unbiased public service to pharmaceutical suppliers. This is their duty.
If they continue down this path, the implementation of Parliamentary Oversight Committee Resolution No. 38—which mandates action on drug price inflation and related irregularities—will remain ineffective. Worse yet, the medical market will increasingly be dominated by shady, direct-purchase deals masked as legitimate procurement, transforming medicine quality and safety into commodities up for sale.
