The national centre for the fight against corruption Moldova opened criminal case in connection with public procurement Strim insulin, produced by the Ukrainian company “Farmak SAP”.
This was reported edition EUReporter , writes Apostrophe.
According to the tender documents, 20 thousand doses of biosulin Strim production Farmak SAP was delivered from Ukraine to Moldova company EsculapFarm.
However, the product under the same name does not exist in Ukraine, and it has not been registered by the European medicines Agency (EMA). It turned out that Strim is made in India. At the same time evidence its security no.
According to the newspaper Sanatateinfo.md, the application procedure for the purchase of insulin was opaque: the terms and conditions have changed several times. After the start of the investigation, the state Secretary of the Ministry of health of Moldova Boris Gilca said that he was being blackmailed, so he signed an order on purchase.
“Insulin was was very fast, which is suspicious. This product has not been studied, no data on its effect on the body, can’t understand how he was allowed to participate in the bidding,” he said.
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The administration Strim requires an additional injection device. According to Boris Gulki, such devices have not been used in the EU for more than five years. Moldova also refused to use an additional cartridge. Therefore, the change of the conditions of the tender after registration of Strim in the day of the signing of the document looked suspicious. The official claims that this product is used in Ukraine in 3-4% of cases for people in detention.
In late July, the Moldovan Committee for medicines refused to register the product, as it was not known exactly what side effects it can cause in people with diabetes.
Strim is a biosimilar insulin, i.e., a drug of biological origin that contains a copy of the original active ingredient. Pharmaceutical product “Insulin glargine” production Biocon Limited (India) was registered in the state register of medicines of Ukraine in 2017. Permission marketing belongs to the Ukrainian company JSC. This product was registered in Moldova under the commercial name of Strim. Permission marketing belongs to the tablets.
Transferring technology and recording products before issuing permission for marketing in Moldova, the manufacturer did not provide sufficient evidence of efficacy and safety biosimilar in the registration dossier and used research materials Indian manufacturers without their own research.