The development of the EDB began in 2018-2019 (in the first phase), based on a Turkish model recognized by the World Health Organization as exemplary.
Since 2022, under the patronage of the President, the second phase of the EDB has been implemented: within six months, a pilot version of the Traceability Module was launched, allowing the tracking of medicines from production to the patient. By March 2023, the system was already fully operational.
Each package of medicine has a unique QR code that provides information about the name of the drug, the manufacturer, the date of release, the batch, the importer, and the place of sale, as well as the regulated price if it is set by the government.
This method of labeling allows for the tracking of medicines: from crossing the border to arrival at the warehouse, delivery to the pharmacy or medical institution, and issuance to the patient. After issuance, the QR code is disabled. The data is stored in the database of the Department of Medicines and Medical Devices and is updated in real time.
Interestingly, Kyrgyzstan did not develop its own QR code standard. Thanks to the efforts of Turkish specialists, the system is adapted to read codes used in most countries, simplifying the import of small batches of medicines.
Currently, 291 medical organizations and 2261 pharmacies are connected to the traceability system.
We spoke with specialists from the Department of Medicines and Medical Devices to find out why this system is important for the state, what advantages it provides to citizens, and how patients can check the quality and authenticity of medicines.
The conversation involved Deputy Director of the Department Mariyam Djankorozova, Head of the Information and Technical Support Department Nuradin Kanataev, and developer of the mobile application "Dary-Darmek" Mirbek Kuduretov.
- The implementation of the traceability system for medicines in Kyrgyzstan has been discussed for a long time. The work began during the tenure of former Minister of Health Talant Batyraliev, and in 2023, with the support of the government and the president, the second phase of the reform started. The scale of the work is indeed significant.
Mariyam Djankorozova: Currently, digital labeling allows for the tracking of many products, such as cigarettes, alcohol, fur coats, and jewelry. However, it is important to note that the safety and quality of medicines and medical devices cannot be assessed by consumers themselves, as is possible with other goods.
For this reason, the traceability of medicines and medical devices is only part of a broad state regulatory system that includes a three-tiered control of safety, efficacy, and quality of pharmaceutical products:
1) State registration.
Medicines and medical devices must be registered in the country after thorough examination. The manufacturer submits a registration dossier to the authorized regulatory body (DLS and MI under the Ministry of Health of the Kyrgyz Republic). In the case of a positive examination, the product is included in the state register of registered medicines or, upon completion of the necessary procedures, in the EAEU register. Only after registration is the use of the drug in medicine and its import into the country or production within the country permitted.
2) Post-registration quality control of products.
Each batch of medicines undergoes quality assessment. Laboratory control is carried out based on regulatory documents that contain quality indicators and testing methods. Only after successful testing is a specific batch allowed to be marketed. If the manufacturer changes the technology or composition of the drug, changes are made to the regulatory document, and subsequent batches are tested according to the updated methods.
3) Pharmacovigilance (medicines) and safety monitoring (medical devices).
Monitoring the safety of medicines on the market is carried out through the collection of spontaneous reports or active pharmacovigilance. In case of reports of adverse reactions to medicines, especially life-threatening ones, the use of the drug is suspended, and an investigation is conducted, after which the product may be withdrawn from the market. In critical situations, the regulator can quickly stop the use of a specific batch of medicine present at all links in the supply chain. It is important to note that for such cases, the EDB provides functionality for suspending the use or recalling the drug at the push of a button.
All regulatory measures also involve mandatory licensing of participants in pharmaceutical activities and compliance with good manufacturing practice (GMP) and good distribution practice (GDP) rules.
The traceability system is integrated into this multi-level regulatory process: starting from state registrations, import control, and quality assessment of each batch, through wholesale and retail links, each package of medicine is monitored at all stages of its movement. This ensures that only registered drugs enter the country, not counterfeit or falsified ones.
Thus, the digitalization of the pharmaceutical system covers the entire regulatory process: registration, import, quality assessment, and, in fact, traceability.
Automation and informatization of the system (EDB) fully comply with national legislation in the field of circulation of medicines and medical devices, ensuring a validated point of entry for goods, i.e., a confirmed source of origin. We know for sure that the drug came from the production site that is registered and approved in the process of state registration of the product. This is a fundamental difference from the labeling systems of other goods. In our system, one cannot simply buy QR codes, stick them on products, and put them into circulation, as is done in fiscal systems for other categories of goods.
As for medicines, the system is structured differently: it begins with the registration of the manufacturer and the drug, and then the traceability mechanism is connected.
- How do medicines enter the market in Kyrgyzstan?
Nuradin Kanataev: To import medicines into the country and sell them in pharmacies, two conditions must be met: 1) the drug must be registered in Kyrgyzstan and included in the state register, which is formed from the EDB (available on the Department's website); 2) each batch must undergo quality assessment in the Department.
If the selected samples pass laboratory control and receive a positive conclusion, the batch is allowed to be marketed in the country, and a list of all issued conclusions is published on the department's website.
Kyrgyzstan is a small country with a relatively low volume of medicine consumption. The total market volume of medicines and medical devices is about 30 billion soms, comparable to the budget of a small European factory. Therefore, we cannot impose additional conditions on global manufacturers.
If the factory already applies a labeling code, it is convenient, and our system can read almost all international code formats. If the manufacturer does not print separate codes for Kyrgyzstan, we do not require this, as we already present a number of complex requirements, such as the presence of instructions in the Kyrgyz language.
To avoid complicating the import process, there is an option to apply stickers with codes within the country. The principle remains the same: the number of packages imported into Kyrgyzstan corresponds to the number of issued and uploaded codes in the system. This is the validation point that ensures control over the volume and authenticity of the product.
Mariyam Djankorozova: This point is indeed important. For example, fiscal systems operate on a different principle: the operator sells their codes, keeps track of them, and monitors the turnover of issued codes.
Our system is structured differently. To avoid creating shortages and complicating imports due to additional requirements, we have provided a maximally flexible mechanism. The system can read almost all international code formats.
If the manufacturer does not have suitable codes, our system can generate them independently — and for free. This is done so that our requirements do not become a reason for reducing supplies and that the population does not face a shortage of medicines.
Thus, codes are uploaded to the system only for those batches that have passed quality assessment. After this, full traceability of each series and package of the drug begins.
- Regarding the traceability system: how many names of medicines are subject to traceability?
Nuradin Kanataev: About 7000 names of medicines are registered in the country. However, not all of them actually enter the market, and not all are currently subject to the traceability system.
We do not trace medicines costing less than 100 soms to avoid affecting their price. Additionally, there are technical limitations. For example, some inexpensive medicines are produced in paper packaging with a rough surface — scanners may not read the code, and stickers may peel off.
Currently, the system covers about 2000 names.
Mariyam Djankorozova: It is important to understand that the term "traceability" is the end result. Before it, there is a significant stage of automation and digitalization of the entire regulatory system.
Our system is not just about tracking goods, as in fiscal systems. It is an integrated regulatory system that starts with the registration of the drug, then includes import procedures, quality assessment, and only after that — traceability.
All these stages are enshrined in legislation: the rules for registration, import, and quality assessment are defined by government decrees. Furthermore, our industry laws explicitly state that the system for the circulation of medicines and medical devices must be transitioned to an electronic management format.
Therefore, it is more accurate to refer to our system as an electronic database of medicines and medical devices, where traceability is just one of the modules.
Fiscal systems for ordinary goods operate differently. For cigarettes or other categories, state registration is not required, where a manufacturer's dossier must be provided, and laboratory control is conducted for each batch. For medicines, however, these are mandatory stages, as they concern the safety of citizens' health.
That is why a more complex and comprehensive system is used for medicines, in accordance with legislative requirements.
- If explained in simple terms for an ordinary citizen: what has changed after the implementation of the electronic database? People do not see the internal processes.
Mariyam Djankorozova: The main result for citizens is the mobile application "Dary-Darmek." Everything that is legally registered and allowed for circulation in the market is displayed in this application.
Mirbek Kuduretov: The application is integrated into the EDB. With its help, one can find a drug and check whether it has been officially imported. It is enough to scan the QR code on the package, and the system will provide information that the medicine has passed state registration and quality assessment, as well as show the quality certificate number.
If the system reports that such a drug is not in the database when scanned, it means that it has not been officially imported or has not passed laboratory testing (or is currently not subject to traceability for drugs below 100 soms). Thus, the buyer can immediately verify the authenticity of the medicine and protect themselves.
Additionally, the application displays maximum retail prices for medicines whose prices are regulated by the state. If a pharmacy sells a drug at a price higher than the established one, the user can file a complaint through the application, specifying the drug, attaching the receipt, and providing their contact details. This information is needed for the authorized bodies to officially register the complaint.
The complaint goes to the EDB, is reviewed, and the applicant receives feedback on the results of the check.
The application also provides access to the instructions for the medicine, which can be viewed or downloaded.
Thus, the application allows citizens to verify the authenticity and quality of medicines, monitor prices, and protect their rights.
- Is it possible to check the availability of medicines in the country?
Mirbek Kuduretov: Yes, this option is available. The application has a search function: you need to enter the name of the drug, and the system will show its availability on the map of Kyrgyzstan.
To avoid overloading the system, the search displays information within a certain radius, for example, within a few kilometers from the user's location.
- Can it be said that all pharmacies in the country are connected to the traceability system for medicines?
Nuradin Kanataev: In fact — yes. Large distributors, from whom pharmacies purchase medicines, do not supply goods to those who are not registered in the system. The transfer of medicines is only possible through the electronic database, so pharmacies are forced to connect.
As the Department of Medicines and Medical Devices, we observe the complete picture for each drug. For example, for a specific medical device, the system shows in which medical institutions and pharmacies it is available and in what quantity. If one package is written off, the remainder is updated in real time. We can see data for any region and any organization.
Mariyam Djankorozova: This system is especially important for medicines issued to privileged categories of patients — people with chronic diseases, epilepsy, bronchial asthma, and other diagnoses. In the future, it can be used to monitor the situation with the availability of medicines. By comparing this data with the patient registry, it is possible to more accurately forecast needs. For example, to monitor the availability of medicines for palliative care or life-saving drugs.
The system contains data on imports and stocks, allowing for analysis of the situation and preventing possible shortages. There is also a stock monitoring module for state hospitals: it allows tracking the arrival of medicines in hospitals and their movement, regardless of whether they are subject to traceability or not, as well as redistributing excess between hospitals. This module is currently being implemented. This is a useful tool for the Ministry of Health, which will be able to see the entire situation in the country. Such functionality is extremely important for inventory management, especially in emergency situations.
The potential of the system is enormous. With full implementation and the development of analytical tools, the Ministry of Health will have great opportunities to improve the provision of medicines to the population.
- Currently, two modules are functioning. What three modules are still in development?
Nuradin Kanataev: These are the modules for the registration of medicines and medical devices, their document flow, and integration with the common processes of the EAEU. These three modules are not yet completed, however, the registration module according to national rules is already partially operational, and some functions are in the testing phase.
Mariyam Djankorozova: Initially, the traceability module was adopted, as well as the stock monitoring in hospitals — a total of two modules. However, only one has been implemented — traceability. The stock monitoring module in hospitals is just being implemented, as there has been a shortage of personnel until recently. And the stock monitoring module is very important for effective inventory management, especially for the Ministry of Health.
For example, to track the availability of medicines in the healthcare network, such as insulins. Insulins are supplied by the state and distributed throughout the healthcare network. Then it turns out that in one place there is an excess of the drug, while in another there is a shortage. This is not a commercial supply, so the Ministry of Health could quickly redistribute medicines across the country.
Now the Ministry of Health is forming a registry of diabetics. If all this is linked into a single system, it will be possible to account for the needs of each patient, as insulin comes in various types and each patient needs a specific one. Thus, distribution will become more accurate.
The EDB covers the entire legislative cycle of the circulation of medicines — all necessary functions are provided. For example, there are functions related to expiration dates: it is visible when the expiration is approaching.
If, for some vital reasons, it is necessary to urgently withdraw a drug from the market, all pharmacies will be notified in the system — a ban on the sale of a specific batch of medicines will be established.
- More than 25 million packages have been withdrawn from circulation. Is it possible to track how many medicines have already been used?
Nuradin Kanataev: Our withdrawal is displayed in real time. We see who has used how much and how much has been withdrawn from circulation. This helps track the movement of medicines to the end consumer.
Complete information about which patient received the medicine will become available after integration with the electronic prescription system. This process is led by the Ministry of Health, so we currently do not have data on end patients.
- Does the traceability system help reduce corruption risks in the medicine market?
Mariyam Djankorozova: Yes, and it is important to understand the mechanism here. If it concerns regulatory documents on quality, laboratory control is not always mandatory for reliable manufacturers and direct supplies. For such supplies, documentary control is sufficient — confirmation that the medicine was produced and supplied directly from a verified manufacturer. This reduces excessive regulatory procedures, saves time, and lowers costs without delaying access to medicines for patients.
The digitalization of the regulatory system makes the work of the regulator and participants in the pharmaceutical market more transparent. All decisions and procedures of the regulator are recorded in the EDB, and they cannot be manually altered after the completion of the input of all modules. This should reduce corruption risks in the pharmaceutical sector of the country.
Thus, the EDB was conceived as a powerful anti-corruption tool: it increases the accountability of the regulator, prevents counterfeit and smuggled medicines from entering the market, protecting the population and strengthening citizens' trust in the state and the healthcare system.
- Has the system managed to control and reduce smuggling? Are there any results?
Nuradin Kanataev: Yes, the results are evident. For example, many medical centers have started purchasing medicines only from official distributors. Previously, this was done by a few, now all centers are transitioning from the "black market" to official supplies.
Additionally, according to data from the association of pharmaceutical manufacturers and suppliers, in 2022, the share of smuggled medicines was about 30-40 percent. Each year, the volume of officially imported medicines increases by about 2 billion soms, while consumption remains virtually unchanged. This shows that the share of smuggling is decreasing, while the proportion of officially imported drugs is growing.
Mariyam Djankorozova: Furthermore, the EDB allows tracking the leakage of drugs from official circulation into the illegal (market). If, for example, a medicine from a hospital ends up in a private pharmacy or on the market, this can be determined by the unique QR code and identify where the leakage occurred. While not everyone is actively using this yet, such an opportunity already exists, which further enhances control and reduces risks of unofficial circulation.
- At the meeting of the Ministry of Health's board, it was mentioned that the work on the traceability system for medicines is nearing completion. Is the work already underway?
Nuradin Kanataev: There is an order for us to complete the work on the registration module for medicines. Currently, a commission for acceptance is working, two meetings have already taken place, and today the third is being held — the process is ongoing. I remind you that when talking about traceability, we are referring to the EDB.
- Can it be said that the system will be fully operational within a year?
Mariyam Djankorozova: The traceability system is already fully operational. The traceability module was adopted back in 2022: it was launched nationwide, training was conducted, and it is now functioning.
What is not yet completed are the modules for the registration of medicines and medical devices. People sometimes confuse this: they think that the system "is not working," but in fact, traceability is functioning. It remains to finalize the registration part, document flow, and integration with the common processes of the EAEU.
Registration is a complex expert process: studying a dossier of thousands of pages, pharmacological, pharmaceutical expertise, and laboratory testing. Ordinary registration takes about 180 days, and there are expedited procedures for strict regulators and manufacturers prequalified by WHO. Currently, this process is being fully digitized: online application submission, distribution to experts, tracking the time of expert work, the order of applications, recording the results of expertise and decisions in digital format, issuing electronic registration certificates, and outputting data to the state register.
Part of the registration is already operational in "combat" mode, including bill generation and interaction with laboratories. The remaining stages involve the acceptance of registration for medical devices, which will complete the digitization of national registration procedures.
- Can you explain how the process of importing and checking documents for medicines works?
Nuradin Kanataev: Each application includes all necessary documents — contract, invoice, quality certificates, accompanying documents, and so on.
For one product, we see a complete set of documents. The supplier uploads them to the system through a personal account. After verification by our staff, the applications are sent to customs, where an electronic customs folder is formed. Everything happens online — customs brokers and the State Customs Service immediately gain access to the documents.
Mariyam Djankorozova: Certificates for customs clearance are usually signed within one day. About 80-90% are processed on the same day. After that, customs clearance takes place, and then the product moves to the next stage — quality assessment.
- What happens if errors are found in the documents?
Nuradin Kanataev: If there are discrepancies, for example, if a barcode is missing, the application is returned for revision. After corrections, it undergoes verification again.
All quality conclusions are available in the register of the Department of Medicines on the website. Any hospital or citizen can check a specific batch of goods on the website, ensuring that it has been officially imported and passed laboratory control.
- What will the state gain when the system operates at full capacity?
Mariyam Djankorozova: Overall, the state will gain complete transparency in the work of the regulator and its accountability in decision-making regarding all its regulatory procedures, as well as across the entire pharmaceutical market.
Market transparency is an indicator of proper state regulation. It will also allow
to promptly receive information about the movement of medicines and medical devices throughout the supply chain, stocks, consumption, and other analytical information.
This will enable quick and adequate management decisions to be made based on reliable data.
The system will enhance the awareness and safety of citizens using medicines and medical devices.
Additionally, it will improve the efficiency of the regulator's work, speeding up procedures by reducing manual processes. Previously, registration dossiers for medicines and medical devices were stored in archives, making it difficult to work with them. In the future, all dossiers will be in electronic form in the EDB. If an investigation into quality is required, all documentation can be quickly checked, samples can be selected, and retesting can be conducted. The entire supply chain has already been digitized, which accelerates processes and reduces the likelihood of errors and other corruption risks.
