EKIP– Expert Club for Economics and Politics A Different Opinion
A few weeks ago, the scandal with the "carcinogenic valsartan" erupted, which quickly swept the media and created the prerequisites for numerous speculations about the quality of medications from this group. We at EKIP reacted quickly by publishing an article by M.A. Pharm. Dimitar Galabov, who clearly explained the problem, emphasizing that there is no need to panic.
What is the danger to patients?
At present, there is no final data on the amount of the impurity found in the substance, but based on a logical analysis of the technological process of the Chinese manufacturer, it is believed that the amount found in the batch is insufficient to cause a negative effect on the patient's health. The withdrawal of the medicinal products has mainly a PREVENTIVE purpose, and is in correlation with the strict safety rules of the EMA, and is not based on proven damage from any medicinal product on the prohibited list. Patients should not be concerned about having taken medicinal products containing valsartan, as well as current or future adverse drug reactions.
The website clinica.bg quotes the Bulgarian Medicines Agency (BDA), where the responsible persons have conducted the necessary studies and stated that some of the medications may return to the market.
Some of the recalled valsartan medications will reappear on the market. The reason is that they do not contain the dangerous ingredient.
Due to carcinogenic impurities in the active ingredient of valsartan from the manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. at the beginning of the month, all batches on the EU market were blocked. As clinica.bg already wrote, the Bulgarian Medicines Agency (BMA) announced that some may return to the market because the manufacturers have stated that they did not use the dangerous ingredient. However, in order to do this, the authorities began to conduct analyses. After the tests, it turned out that a batch with No. VJSC17005-A of the holder of the marketing authorization Pharmacons could be released.
Since in most cases, drug manufacturers have contracts with more than one active ingredient manufacturer, it was possible to carry out rapid and effective monitoring. In this way, cases of NDMA contamination were isolated.
"In the dossier of the authorization for use of the medicinal product Valsarcon 160 mg film-coated tablets, in addition to the affected manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd., China, a second alternative manufacturer of the active substance valsartan Aurobindo Pharma Limited, Plot No. 2, Maitrivihar, Ameerpet, 500 038 Hyderabad, Telangana, India, is listed," the BDA explained. The agency added that the holder of the authorization for use has provided full evidence that the indicated batch was not manufactured with the dangerous active substance. It is not yet clear whether more batches of other companies will be unblocked.
