The Russian pharmaceutical market is facing a massive regulatory paradox. Despite a decade of active implementation of Good Manufacturing Practice (GMP) standards, hundreds of production sites continue to supply medicines to the Russian Federation without ever undergoing an inspection by the Russian state inspectorate. This was stated on February 19 in Sochi by Vladislav Shestakov, Director of the Federal State Institution “SID & GP” of the Ministry of Industry and Trade of the Russian Federation, speaking at the XIX “Pharmprojections” conference.
Shocking Statistics
Summarizing the results of 2025, the head of the specialized institute announced data obtained from the Ministry of Health. It turned out that there is a “large pool” of companies on the market — about 700 manufacturers that have never undergone an inspection by the Russian regulator over the past 10 years.
The scale of the problem becomes obvious by comparison: in just a decade of the institute’s work, about 1,500 manufacturers were inspected. Thus, the number of uninspected sites is almost half of the inspected volume.
“This statistic, to put it mildly, deeply astonished us… We are talking about companies, production sites that have never been [inspected]. One could, of course, argue that perhaps some underwent inspections in other countries, but that would definitely be a small number.”
— Vladislav Shestakov, Director of the FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation
How Does the “Loophole” Work?
The existence of such a large number of companies outside the control perimeter is explained by the specifics of the legislation. These manufacturers legally supply products registered many years ago. However, their activities are essentially “frozen”:
- They cannot make changes to the regulatory documentation.
- They are prohibited from changing the packaging or instructions.
- They cannot expand the list of indications for use.
“As they sold 11 years ago, they can safely continue to supply in the same form,” the speaker explained.
A Matter of Principle
The situation looks paradoxical against the background of basic requirements for the quality control of medicines. The law explicitly establishes the mandatory nature of undergoing inspections; however, a serious contradiction arises in practice.
“The formula is simple, it does not allow for double interpretation: if a GMP certificate is not issued, the product is not sold. We already have a paradoxical situation; the law explicitly establishes the mandatory obtaining of a certificate and regular inspections, thereby confirming manufacturing practices, but in reality, almost 700 manufacturers somehow exist here.”
— Vladislav Shestakov
