Kazakhstan plans tighter medicine-sale controls from January 1

Marina Kovaleva

Kazakhstan’s Ministry of Health and Ministry of National Economy have drafted an order to introduce tighter state controls over medicine sales from 1 January next year, with illegal trading targeted across pharmacies, marketplaces and social networks.

The ministries intend the project to curb illegal pharmaceutical trading and make inspections more selective. It revises the checklists used by inspectors and the criteria used to assess risk in the pharmaceutical market. They set the objective as making state control “more targeted and effective,” concentrating attention on violations that create a direct threat to life and health.

What will inspectors target?

The draft identifies four categories of priority violations:

• Selling medicines without the required licence.
• Distributing counterfeit medicines.
• Selling unregistered pharmaceutical products.
• Releasing psychotropic, narcotic or potent drugs without a prescription.

The measures address illegal trade not only in pharmacies but also on marketplaces and in social networks. The document therefore extends risk-based pharmaceutical oversight beyond the conventional pharmacy counter to the two digital sales channels named in the draft.

When inspectors identify one of the listed violations, supervisory bodies may promptly suspend the organization’s operations, seize questionable products and block their sale. The order links detection of a breach with three enforcement tools: an operational suspension, product seizure and a sales block.

How will inspection schedules change?

The draft also changes the planning of preventive inspections, or scheduled checks used to identify violations. Pharmacies and pharmaceutical companies will be selected through risk-based scheduling, which ranks sites for inspection according to their assessed risk.

Three types of information will shape the schedule:

• The organization’s history of previously identified violations.
• Data supplied by other government agencies.
• Results from earlier investigations.

Regulators will use the combined information to estimate the actual risk associated with each site. Organizations with a documented history of breaches will receive priority. The ministry expects this approach to “allocate state-control resources more efficiently” and reduce unnecessary administrative barriers for compliant businesses.

The revised checklists and risk criteria will support that selection. Together, they should make supervisory attention more closely tied to each organization’s record and assessed level of risk.

What changes for pharmacies and medicine sellers?

For pharmacies and pharmaceutical companies, the stated benefit is a lower administrative burden when they have no history of violations. They may also face fewer unnecessary checks under the new planning model because regulators will prioritize organizations where inspectors have already found problems.

For sellers involved in illegal trade, the change is faster and broader intervention. A licence breach, counterfeit product, unregistered medicine or unauthorized prescription-free sale may lead regulators to suspend operations, seize questionable goods and block further sales. The rules name marketplaces and social networks alongside pharmacies as channels where the state seeks to stop illicit medicine trading.

The effective date remains a planned one. The ministries have prepared a draft and intend the changes to take effect on 1 January next year. Until adoption, the document sets out the enforcement direction rather than an operating regime already in force.

The initiative also follows a previously reported decision by the Health Ministry to strengthen oversight of the quality of medicines and medical devices from the new year. The new draft focuses specifically on pharmaceutical-market control, including who may sell medicines, whether products are genuine and registered, and when controlled substances may be dispensed.

In practice, compliant operators should see less routine scrutiny, while high-risk sellers face faster suspension, seizure and sales restrictions.