ISLAMABAD: Nine pharmaceutical companies have been directed by the Drug Regulatory Authority of Pakistan (Drap) to recall medicines of high blood pressure, manufactured by them, as a contaminated raw material used in these medicines can cause cancer.
According to a local media report, these directions came from the European Medicating Agency (EMA) which pointed out that the raw material was contaminated.
An official from Drap was quoted in the report stating that this ‘incident has exposed the flaws in Drap as 95 per cent medicines in Pakistan are made with imported raw material’. However, a spokesperson said that this was proof that Drap is taking all possible measures to safeguard people’s health as a prompt action was taken.
According to a recall letter issued by Drap stated that an impurity was detected by the EMA. The N-Nitrosodimethylamine (NDMA) — in the valsartan active ingredient which the company supplied to manufacturers in some areas of the European Union (EU) and in Pakistan.
The letter claims that NDMA is classified as a probable carcinogenic (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is sought to be related to changes in the way the active substance was manufactured.
The drug inspectors and health departments have been informed that the recall shall also be implemented on all medicines containing valsartan manufactured by the Chinese company whether locally manufactured or imported ones, claims the letter.
Earlier, in 2012 more than 200 patients died after they took contaminated medicine from PIC Pharmacy.