DRAP removes unrest with guidelines for patients, pharmaceuticals

Islamabad : The Drug Regulatory Authority of Pakistan (DRAP)has clarified that Valsartan medicine made by Pakistani companies is not banned, and only batches manufactured and supplied by M/s Zhejiang Huahai Pharmaceuticals, China, and containing the active substance the refrom are being recalled. Pakistani companies can manufacture and sell Valsartan medicine made from Valsartan raw material imported from other qualified sources.

The clarification comes in the wake of misconceptions created due to the recall issued for Valsartan raw material manufactured and supplied by M/s Zhejiang Huahai Pharmaceuticals, China. The recall of batches of Valsartan medicine used to control blood pressure was issued by the European Medicine Agency (EMA) following detection of N-nitrosodimethylamine (NDMA), in the Valsartan active substance manufactured and supplied by M/s Zhejiang Huahai Pharmaceuticals. The Agency will review to ascertain the levels of NDMA in these valsartan medicines, it’s possible impact on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

Patients and prescribers have been calling DRAP whether valsartan medicine manufactured by Pakistani companies produces cancer or are banned or they should stop taking medicine. In clarifying the doubts of patients, DRAP has stated that an unexpected impurity has been found in the active ingredient used to make some Valsartan medicines; and that only those Valsartan medicines affected in Pakistan are being recalled. “You should not stop taking your Valsartan medicine unless you have been told to do so by your doctor or pharmacist. You may be given a different valsartan medicine (or an alternative treatment) when you go for your next prescription.

If you have any questions about your treatment, speak to your pharmacist who can tell you if your medicine is being recalled,” the press statement guides.

As far as healthcare professionals are concerned, DRAP has informed that N-nitrosodimethylamine (NDMA) has been detected in the Valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals. As a result, Valsartan medicines only containing the active substance from Zhejiang Huahai, China, are being recalled in Pakistan.