Provincial Pharmacovigilance Center Punjab alerted manufacturers to review their sources of materials of Valsartan
In the past week, the Provincial Pharmacovigilance Center Punjab alerted the manufacturers to review their sources of raw materials of Valsartan — a formula for manufacturing medicines used in the treatment of hypertension and serious heart conditions. This resulted in the Drug Regulatory Authority of Pakistan (DRAP) ordering a recall of some batches of medicines manufactured by using Valsartan as a raw material, and supplied by a particular Chinese company. The recall of the medicines came at the pointation of the European Medicine Agency (EMA) in the wake of the detection of N-nitrosodimethylamine (NDMA) — a cancer-causing impurity — in the Valsartan active substance.
The incident raises serious questions regarding the methods used by the Pakistan Pharmaceutical Manufacturing Industry (PPMI) for quality assurance purposes. While all raw materials used in pharmaceutical manufacturing are supposed to undergo proper testing before their release for commercial production, it appears as if our pharmaceutical industry does not have any mechanism for a verification of its own, and solely relies on the Certificate of Analysis issued by the supplier. This puts the lives of unsuspecting patients at serious risk and has surprisingly gone undetected by the regulatory authorities until a voluntary disclosure by the EMA.
Even more surprising is the fact that after several weeks of the EMA alert, physical recall of the products containing the contaminated raw material is yet to start and the same continues to occupy the shelves at drug stores and continues to be prescribed by doctors as well. In more developed and regulated markets, such actions are taken jointly and responsibly by the industry as well as the regulators to ensure patient safety. Timely notice of the issue is of utmost importance as it is a matter involving public health and precious lives.
Published in The Express Tribune, July 21st, 2018.