This is evident from research by NRC and television program Zembla. NRC and Zembla had samples of three batches of the analgesic and fever inhibitor produced by Anqiu Lu’an tested by a certified laboratory in Germany. The three contaminated lots were produced in the spring of 2019 and account for some 36 million pills of paracetamol.
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The laboratory analysis shows that all three parties are contaminated with 4-chloroaniline, abbreviated PCA. This substance, which arises from the production of paracetamol, is carcinogenic according to the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA).
However, the organizations differ on the maximum permitted daily dose that a person may take. While EMA finds six contaminated pills a day acceptable, according to EFSA, more than one contaminated pill a day is already an unacceptable cancer risk. EFSA says it has stricter rules because the substance can affect DNA.
In the Netherlands
It is not clear where the paracetamol ended up. Two billion pills, powders and drinks are sold annually in the Netherlands. Roughly half of this is made by the Apotex pharmaceutical company in Leiden, a subsidiary of the Indian group Aurobindo.
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According to sources around the company, Apotex had Anqiu Lu’an as its main raw material supplier in recent years. Apotex makes paracetamol for the (house) brands of Albert Heijn, Etos, Jumbo, Trekpleister, DA and Kruidvat, among others. Aurobindo refused to respond to questions from the newspaper and the television program.
‘Below limit’
NRC and Zembla have informed the Healthcare and Youth Inspectorate (IGJ) and the Medicines Evaluation Board (MEB) about the pollution found. The IGJ announced in an e-mail that it sees ‘no role’ for itself in this matter for the time being.
The MEB sees no reason to detect contaminated parties or to conduct broader investigations. According to the MEB, the pills examined fall “well” below the limit that the EMA drug agency applies.
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