Domestic pharmaceutical manufacturers hope to simplify the procedure and conditions for state registration of active pharmaceutical ingredients (API), which will allow maintaining the volume of drug production in conditions of API shortage, said President of the Association of Manufacturers of Medications of Ukraine (AMMU) Petro Bahriy.
“At one of the meetings in the Ministry of Health, it was decided to simplify the procedure and conditions for state registration of APIs that are part of all medicines, due to the aggravation of the problems of supplying raw materials for the production of drugs to Ukraine due to the introduction of restrictions on export by main suppliers (China, India), in case of replacement of the API manufacturer for the registration of alternative API suppliers in order to avoid a shortage of necessary medicines,” he said in an exclusive interview with Interfax-Ukraine.
The head of the AMMU also noted that domestic pharmaceutical manufacturers hope that the possibilities of using mechanisms of state guarantees, state orders and state reserves for the procurement of medicines will be considered.
At the same time, Bahriy believes that one of the real steps of the state, which would allow solving the problem of the deficit of imported APIs, could be an appeal by the Ukrainian embassies to the governments of the countries in which APIs are produced.
“We need to consider real steps. This can be help from our embassies, which can appeal to the governments of the states where APIs are produced, for example, China or India, so that they somehow pay attention to Ukraine, increase quotas. Although we understand that the effect of this is unlikely will take place, since the United States, the EU, and the whole world, which is in line, turn to these governments,” he said.
APIS, DEFICIT, PHARMA, PROCEDURE, STATE REGISTRATION
