The work on the EDB began in 2018-2019 (Phase 1), and it was created based on a Turkish model recognized as high-quality by the World Health Organization.
Since 2022, with the support of the President, the second phase of the EDB implementation has begun: within six months, a pilot version of the traceability module was launched, which allows tracking the path of a medicine from production to the patient. By March 2023, the system was already fully operational.
Each package of medicine now has a unique QR code that provides access to information about the drug's name, manufacturer, release date, serial number, importer, and point of sale, as well as a fixed price if it is regulated by the state.
This labeling allows the system to track the movement of medicines: from crossing the border to arriving at the warehouse, being sent to a pharmacy or medical institution, and being issued to the patient. The QR code is deactivated after issuance, and the information is updated in real-time in the database of the Department of Medicines and Medical Devices.
Interestingly, Kyrgyzstan did not develop its own QR code standards. The system is adapted to international formats with the help of Turkish specialists, which simplifies the import of small batches of medicines.
As of today, 291 medical organizations and 2261 pharmacies are connected to the traceability system.
Specialists from the Department of Medicines and Medical Devices shared their views with AKIpress on the importance of the system for the state, its benefits for citizens, and ways to verify the quality and authenticity of medicines.
The discussion involved Deputy Director of the Department Mariyam Zhankorozova, Head of the Information and Technical Support Department Nuradin Kanataev, and developer of the mobile application "Dary-Darmek" Mirbek Kuduretev.
- The traceability system for medicines in Kyrgyzstan has been discussed for a long time. The implementation began under the former Minister of Health Talant Batyraliev, and in 2023, with the support of the state and the president, the second phase of the reform started. The work done is indeed extensive.
Mariyam Zhankorozova: Currently, digital labeling covers various goods such as cigarettes, alcohol, and jewelry. However, medicines and medical devices require a special approach, as their safety, efficacy, and quality cannot be determined by the consumer independently, unlike other goods.
Therefore, the traceability of medicines is part of a broad state regulation system, which includes a three-tier control over the safety, efficacy, and quality of pharmaceutical products:
1) State registration.
Medicines and medical devices must be registered in the country after a thorough specialized 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 case of a positive conclusion, the product is entered into the state register or the EAEU register. Only after this is the use of the medicine in medicine and its import into the country permitted.
2) Post-registration quality control: during import or production in the country.
Each batch of medicine undergoes a quality assessment. Laboratory control is carried out according to regulatory documents that contain quality parameters and testing methods. Only after successful verification is a specific batch of the medicine allowed for circulation in the market. If there are changes in the technology or composition of the medicine, amendments are made to the regulatory documents.
3) Pharmacovigilance and safety monitoring: monitoring the safety of products already on the market, taking into account reports of adverse reactions.
Upon receiving reports of serious adverse reactions, the use of the medicine may be temporarily suspended until an investigation is conducted. If necessary, the regulator can quickly stop the use of a specific batch of medicine at all levels of the supply chain. Importantly, the EDB has implemented functionality to stop the use of a medicine or recall it with the push of a button.
Regulatory measures include mandatory licensing of pharmaceutical entities and compliance with the requirements of good manufacturing and distribution practices.
The traceability system is integrated into a multi-level regulatory process, starting from state registration and import control to quality assessment. Each package of medicine is monitored at all stages, ensuring that only registered medicines, and not counterfeit ones, enter the country.
Thus, the digitalization of the medicine system covers the entire regulatory process: from registration and import to quality assessment and traceability.
Automation and informatization of the EDB system fully comply with national legislation in the field of circulation of medicines and medical devices, ensuring a confirmed source of product origin. We know for sure that the medicine came from a registered production site. This is an important distinction from the labeling systems of other goods. In our system, you cannot simply purchase QR codes and stick them on products, as is done in other categories of goods.
In the case of medicines, the system works differently: it starts with the registration of the manufacturer and the medicine, and then the traceability mechanism is activated.
- How do medicines enter the market in Kyrgyzstan?
Nuradin Kanataev: To import a medicine into the country and sell it in pharmacies, two conditions must be met: 1) the medicine must be registered in Kyrgyzstan and included in the state register generated from the EDB (which is available on the Department's website); 2) each batch must undergo quality assessment at the Department.
If the samples selected for quality control pass laboratory testing and receive a positive conclusion, the batch is allowed for circulation, and information about all issued conclusions is published on the department's website.
Kyrgyzstan is a small country with a limited volume of medicine consumption. The total volume of the pharmaceutical market is about 30 billion soms, which is comparable to the budget of a small European factory. Therefore, we cannot impose additional requirements on global manufacturers.
If a factory already applies a labeling code, it is convenient, and our system can read almost all international formats. If the manufacturer does not print separate codes for Kyrgyzstan, we do not require this, as we already impose 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 unchanged: for the number of packages imported into Kyrgyzstan, the same number of codes is issued, which are uploaded into the system. This is the validation point that ensures control over the volume and authenticity of the product.
Mariyam Zhankorozova: Yes, this is an important point. For example, fiscal systems operate on a different principle: the operator sells their codes, keeps track of them, and monitors the turnover based on the issued codes.
Our system is arranged differently. To avoid creating a shortage and complicating imports due to additional requirements, we have provided maximum flexibility. The system can read almost all international code formats.
If the manufacturer does not have suitable codes, our system can generate them independently—free of charge. This is done so that our requirements do not become a reason for shortages and that the population does not face a lack of medicines.
Thus, codes are uploaded into the system only for those batches that have passed quality assessment. After that, full traceability of each batch and package of the medicine begins.
- How many names of medicines are traceable?
Nuradin Kanataev: In total, about 7000 names of medicines are registered in the country. However, not all of them are actually imported, and not all fall under the traceability system.
We do not trace medicines costing less than 100 soms to avoid raising their prices. In addition, there are technical limitations. Some inexpensive medicines are packaged in paper packaging with a rough surface, and the scanner may not read the code, and the sticker may simply peel off.
Currently, traceability covers about 2000 names.
Mariyam Zhankorozova: It is important to note that the term "traceability" is the end result. Before that, there is a large stage of automation and digitalization of the entire regulatory system.
Our system is not just tracking goods, as in fiscal systems. It is a seamless and linear regulatory system that starts with the registration of the medicine, then includes import procedures, quality assessment, and only after that traceability.
All stages are enshrined in legislation: the rules for registration, import, and quality assessment are defined by government resolutions. Moreover, our laws explicitly state that the system for the circulation of medicines and medical devices must be transitioned to an electronic management format.
Therefore, it would be more accurate to call our system an electronic database of medicines and medical devices, where traceability is just one of the modules.
Fiscal systems for ordinary goods operate on a different principle. For cigarettes or other categories, state registration is not required, where a manufacturer's dossier must be provided, and laboratory testing is conducted for each batch. However, for medicines, these stages are mandatory, as they concern the safety of citizens' health.
For this reason, a more complex and comprehensive system is applied to medicines, in accordance with legislative requirements.
- What has changed for the ordinary citizen after the implementation of the electronic database? People do not see the internal processes.
Mariyam Zhankorozova: The main advantage for citizens is the mobile application "Dary-Darmek." All information about legally registered and permitted medicines is available in this application.
Mirbek Kuduretev: The application is integrated into the EDB. You can find a medicine and check whether it has been officially imported. Just scan the QR code on the package, and the system will show information that the medicine has passed state registration and quality assessment, as well as the quality certificate number.
If the system reports that such a medicine is not in the database when scanned, it means that it has not been officially imported or has not passed laboratory testing (or is not yet subject to traceability for medicines costing less than 100 soms). This allows the buyer to verify the authenticity of the medicine and protect themselves.
Additionally, the application displays the maximum retail prices for medicines whose prices are regulated by the state. If a pharmacy sells a medicine for more than the established price, the user can file a complaint through the application: select the medicine, attach the receipt, and provide their contact information. This information is necessary for the official registration of the complaint.
The complaint is sent to the EDB, reviewed, and the applicant receives a response about the results of the check.
The application also allows you to open the instruction for the medicine, which can be viewed or downloaded.
Thus, the application gives citizens the opportunity to verify the authenticity and quality of medicines, monitor prices, and protect their rights if necessary.
- Is it possible to check the availability of medicines in the country?
Mirbek Kuduretev: Yes, this is possible. The application has a search function: you need to enter the name of the medicine, and the system will show its availability on the map of Kyrgyzstan.
To avoid overloading the system, the search displays information within a radius, for example, within a few kilometers from the user's location.
- Are all pharmacies in the country connected to the traceability system for medicines?
Nuradin Kanataev: In principle—yes. Large distributors, from whom pharmacies purchase medicines, do not supply goods to those who are not registered in the system. Medicines can only be transferred through the electronic database, so pharmacies are forced to connect.
As the Department of Medicines and Medical Devices, we have complete information about each medicine. For example, the system shows where and in what quantity a specific medicine is available in medical organizations and pharmacies. If one package is written off, the remainder is automatically updated in real-time. We can see data for any region and any organization.
Mariyam Zhankorozova: 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, the system can be used to monitor the availability of medicines. By correlating 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 information about imports and stocks, which allows for analyzing the situation and preventing possible shortages. A stock monitoring module for state hospitals is also provided, which allows tracking the receipt of medicines and their movement, regardless of whether the medicine is traceable or not, and redistributing excess between institutions. This module is currently being put into operation and will become a useful tool for the Ministry of Health, providing a complete picture of the situation in the country. Such functionality is 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 opportunities to improve the provision of medicines to the population.
- Currently, two modules are functioning. Three remain. What are these modules?
Nuradin Kanataev: These are the modules for the registration of medicines and medical devices, document flow, and integration with the general processes of the EAEU. These three modules have not yet been accepted, but the registration module according to national rules is already operating in test mode, and part of the functionality is undergoing testing.
Mariyam Zhankorozova: Initially, the traceability module was adopted, as well as the stock monitoring in hospitals, of which only the traceability module has been implemented so far. The stock monitoring module in hospitals is now being introduced, as there was a shortage of staff until recently. This module is extremely important for inventory management, especially for the Ministry of Health.
For example, it allows tracking the availability of medicines in the healthcare network, such as insulins, which are provided by the state and distributed throughout the system. A situation may arise where there is an excess of the medicine in one place, while another place lacks it. Since this is not a commercial supply, the Ministry of Health can quickly redistribute medicines across the country.
Currently, the Ministry of Health is forming a registry of diabetics. If this is combined into a single system, it will be possible to account for the needs of each patient, as insulin comes in different types, and each patient requires a specific one. This will ensure more targeted and accurate distribution.
The EDB covers the entire legislative cycle of the circulation of medicines—providing all necessary functionality. For example, there are functions related to expiration dates: it shows when they expire.
If, for any reason related to a threat to life, it becomes necessary to urgently recall a medicine from the market, all pharmacies will be notified through the system—there will be a ban on the sale of a specific batch of the medicine.
- More than 25 million packages have been withdrawn from circulation. Is there a way to see how many medicines have already been used?
Nuradin Kanataev: We see the withdrawal immediately. We can track who has used how much and how much has been withdrawn from circulation. This helps control the movement of the medicine to the end consumer.
Complete information about which patient received the medicine will be 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 the end patients.
- Does the traceability system reduce corruption risks in the medicine market?
Mariyam Zhankorozova: Yes, and it is important to understand the mechanism here. If we are talking about regulatory documents on quality, then 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 specifically from a verified manufacturer. This reduces excessive regulatory procedures, saves time, and lowers costs without slowing down access to medicines.
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, which eliminates the possibility of their manual substitution after the full introduction of all modules. This should reduce the corrupt components in the pharmaceutical sector of the country.
Thus, the EDB is designed 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 it been possible to control and reduce smuggling with the help of the system? Are there results?
Nuradin Kanataev: Yes, the results are evident. Many medical centers have started purchasing medicines only from official distributors. Previously, only a few did this; now all centers are transitioning from the "black market" to official supplies.
Moreover, 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 indicates that the share of smuggling is decreasing, while the volume of officially imported medicines is increasing.
Mariyam Zhankorozova: The EDB also provides the opportunity in the future to track the leakage of medicines from official circulation to illegal. If, for example, a medicine from a hospital ends up in a private pharmacy or on the market, it can be identified by its unique QR code, and the source of the leakage can be determined. Although not everyone actively uses this opportunity yet, it already exists and enhances control and reduces the risks of unofficial circulation.
- At the meeting of the Ministry of Health's board, it was mentioned that work on the traceability system for medicines has been completed. Work is already underway, isn't it?
Nuradin Kanataev: There is an order for the acceptance of the medicine registration module. Currently, a commission for acceptance is working, two meetings have already taken place, and today the commission is meeting for the third time, so the process is ongoing. It should be noted that when traceability is mentioned, it refers to the EDB.
- Can we expect that the system will be fully operational within a year?
Mariyam Zhankorozova: The traceability system itself 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 the system is "not working," but in fact, traceability is functioning. The registration part, document flow, and integration with the general processes of the EAEU still need to be finalized.
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; there are also expedited procedures for strict regulators and manufacturers that have been prequalified by WHO. Currently, the process is being fully digitized: online application submission, distribution to experts, tracking the working time of experts, the order of applications, recording the results of expertise and decisions in digital format, issuing electronic registration certificates, and entering data into the state register.
Part of the registration is already functioning in "combat" mode, including the formation of invoices and interaction with laboratories. The remaining stages include the acceptance of registration for medical devices, which will complete the digitization of national registration procedures.
- How is the import and document verification for medicines carried out?
Nuradin Kanataev: Each application includes all necessary documents—a contract, invoice, quality certificates, shipping documents, and others.
For one product, we see the complete set of documents. The supplier uploads them into 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 GTS immediately gain access to the documents.
Mariyam Zhankorozova: Certificates for customs clearance are usually signed within one day. About 80-90% are issued on the same day. After that, customs clearance is conducted, and the next stage in the system is the quality assessment procedure.
- 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 correction, 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 to ensure that it has been officially imported and passed laboratory control.
- What will the state gain when the system operates at full capacity?
Mariyam Zhankorozova: 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 throughout the pharmaceutical market.
Market transparency is an indicator of proper state regulation. This will allow
to promptly obtain information about the movement of medicines and medical devices throughout the supply chain, stocks, consumption, and other analytical information.
This will enable timely and adequate management decisions based on reliable data.
This will increase the awareness and safety of citizens using medicines and medical devices.
The system will enhance the efficiency of the regulator's work, reduce the time of procedures by minimizing 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 available in electronic form in the EDB. If it is necessary to conduct an investigation regarding quality, all documentation can be quickly checked, samples can be selected, and retesting can be conducted. The entire supply chain has already been digitized, which speeds up processes and reduces the likelihood of errors and corruption risks.
