Paracetamol with a carcinogenic substance may have entered the Dutch market, according to research by Zembla and NRC on Thursday .
Zembla and NRC had samples from the largest manufacturer of paracetamol, the Chinese Anqiu Lu'an Pharmaceutical, examined by a certified laboratory in Germany.
Three lots from the spring of 2019 - good for millions of pills - were found to be contaminated with the carcinogenic 4-chloroaniline (PCA). It is not possible to say with certainty where these pills ended up.
It is known that half of the paracetamol in the Netherlands is made by pharmacist Apotex in Leiden, daughter of the Indian concern Aurobindo. Sources confirm to Zembla and NRC that the company had Anqiu Lu'an as its main raw material supplier in recent years. Apotex makes paracetamol for Albert Heijn, Etos, Jumbo, Trekpleister, DA and Kruidvat, among others.
Supervisors disagree on PCA harmfulness
European regulators do not agree to what extent PCA is carcinogenic. The European Medicines Agency (EMA) finds six pills of paracetamol containing this substance acceptable, while the European Food Safety Authority considers one pill too high a risk of cancer.
NRC and Zembla have asked the Healthcare and Youth Inspectorate (IGJ) and the Medicines Evaluation Board (MEB), which monitor the quality of medicines, to respond. The Inspectorate sees "no role" for itself in this story and the MEB is not going to conduct a broader investigation into the matter. The MEB refers to the limit that the EMA drug agency applies.