Uzbekistan’s Anti-Corruption Agency has identified serious systemic shortcomings in the pharmaceutical sector following an analysis of court materials related to the Dok-1 Max case, according to a report reviewed by Gazeta.uz.
The agency’s findings point to weaknesses in the processes for registering, certifying, and licensing medicines, where insufficient transparency and limited digitalization allowed a high degree of human discretion. This, in turn, created conditions for corruption risks to emerge.
The case has already led to criminal convictions. On February 26, 2024, a Tashkent court sentenced several individuals to prison terms ranging from three to 20 years. Court documents indicate that during the registration of Dok-1 Max, a number of procedural violations occurred, including decisions that failed to meet established requirements.
According to the agency, one of the key institutional problems lies in the structure and operation of the expert council under the Center for the Safety of Pharmaceutical Products, which operates within the Ministry of Health. The procedure for selecting council members and forming its composition was not defined in any legal document. Although the council consists of 17 members with independent voting rights, some simultaneously held senior positions within the same institution, creating a conflict of interest.
The report cites the example of a department head who participated in the registration process for Dok-1 Max while also voting as a council member. Such overlap, the agency noted, undermined the independence of decision-making.
Transparency issues were also highlighted. The council did not publish quarterly or annual reports, lists of members, or the outcomes of drug registration decisions on its official website. In addition, procedures for conducting inspections of pharmaceutical enterprises and disclosing their results were not clearly regulated, further contributing to corruption risks.
The agency also found that inspection mechanisms were not aligned with international standards. A 2021 government resolution designated a single state enterprise as the sole body responsible for inspections, a structure the agency said contradicts recommendations by the World Health Organization and European regulatory bodies. Under international practice, such oversight is generally carried out directly by the Ministry of Health.
In response to these findings, authorities have taken steps to reform the system. All processes related to the registration, certification, and licensing of pharmaceutical products have now been fully digitalized. In addition, registration certificates for at least 92 types of medicines have been revoked, and their production, import, and sale have been banned following re-evaluation.
The agency recommended further measures, including transitioning all drug registration procedures to a fully online system, ensuring open access to information, increasing transparency in the expert council’s activities, and aligning inspection practices with international standards.
The Dok-1 Max case has drawn international attention since late 2022, when reports emerged that children in Uzbekistan had died after consuming the cough syrup produced by India-based Marion Biotech. Initial reports cited 18 deaths in December 2022, followed by dozens more cases revealed in 2023. During the trial, prosecutors alleged that officials had accepted a $33,000 bribe to bypass proper testing procedures.
The fallout has extended beyond Uzbekistan. Indian authorities launched nationwide inspections of pharmaceutical plants, finding that fewer than a quarter of the country’s 8,500 small manufacturers met World Health Organization standards.
