Hundreds of thousands of patients took medications for hypertension that may have been defective. Almost all of their producers were supplying one factory in China.
The Chief Pharmaceutical Inspector (GIF) stopped trading 40 drugs of a dozen or socompanies. The reason is the same: they contain the active substance, valsartan, from the same Chinese manufacturer. There are many indications that part of its production was contaminated. - We do not know yet whether the defect exists at all. We also do not know if it is serious - the person is perfectly aware of the matter.
The main pharmaceutical inspector was already talking urgently with the Minister of Health about valsartan. The whole matter is coordinated at the EU level, as the situation concerns not only Polish drug surveillance and patients, but most European Union countries.
The worst are even afraid to think
Several scenarios are drawn. An optimistic variant is the statement that valsartan has not been contaminated in China. Then the products stopped in the market will return to the market, and those who have already taken them have nothing to fear.
Variant two: a qualitative defect occurs but does not threaten human health. However, it would be very disruptive for patients. - The lack of availability of suspended medicines containing valsartan may mean that many patients will have to be switched to their equivalents - notes Marek Tomków, vice-president of the Supreme Pharmaceutical Council. Why? Because almost all manufacturers bought the active substance in one factory. Our information shows that not only Polish entrepreneurs, but also those from other Member States. The result: there is no "pure" valsartan on the market for some time.
About the third variant - where a qualitative defect would threaten human health - so far no one wants to even think. It would be the biggest pharmaceutical scandal in history. - The matter is a priority for us. There is currently no more important - we hear in GIF. We have received assurance that Polish services are prepared for all of the above-mentioned scenarios. And patients can only wait for now. - The truth is that the problem is pan-European. Nothing more, neither we nor the pharmaceutical inspection can do - informs a valid official at the Ministry of Health.
The price of health
Regulations do not prohibit the supply of active substances in Asia. Most European manufacturers buy them in China and India. Why did almost everyone take valsartan from one factory? - Because she had the best prices. An open question remains whether the margin was limited or the savings were made on quality control - we hear from one of the officials.
Experts emphasize that the quality of production in Chinese factories has been unknown for years. There is no doubt that it is the Asians who have the most modern equipment and outstanding experts. - The problem is that many local entrepreneurs compete on price for customers from Europe. As a result, the quality suffers.