Studying the local manufacturing content of pharmaceutical substances used in inhalation drugs

Introduction. Drug safety is a part of national security. An important task is to develop a full-cycle domestic

pharmaceutical manufacture, including the production of local pharmaceutical substances. Aim. To study the local

manufacturing content of pharmaceutical substances included in inhalation drugs. Materials and Methods. The study

objects were data from the Common Register of the Authorized Medicinal Products registered within the EAEU, the State

Register of Medicines, and scientific literature data. To identify the ratio of shares of domestic and foreign inhalation drugs

and their dependence on the raw material origin, a methodology was used to assess the degree of the local content of

drug production considering the country of origin of the pharmaceutical substance. Results and Discussion. The study

showed that about 50% of domestic inhalation drugs are made from imported pharmaceutical substances, while 40%

are fully imported. An analysis of data on the registration of inhalation drugs since 2022 has revealed that 86% of the

brand names were registered for the first time. The main suppliers of pharmaceutical substances are India (66%) and

Italy (22%). Only 3% of pharmaceutical substances are produced by domestic enterprises. A Pareto analysis has shown

that 5 countries (India, Italy, the United Kingdom, Germany, and Switzerland) supply 78% of pharmaceutical substances.

61% of international non-proprietary names of pharmaceutical substances are registered in both the State Register of

Medicines and the Common Register of the Authorized Medicinal Products registered within the EAEU. Conclusions.

About 90% of inhalation drugs are manufactured from imported pharmaceutical substances, while only 1% of drugs are produced domestically from local pharmaceutical substances. A high demand was identified for establishing our local

manufacturing content pharmaceutical substances to address the issue of import substitution.