Health Canada, the government department responsible for national public health, in its recent announcement unveiled that it has found the manufacturing site of Chinese drug Zhejiang Huahai Pharmaceuticals to be non-compliant with the requirements of GMPs (Good Manufacturing Practices).
GMPs, for the record, are international standards that help ensure that drugs are consistently tested, manufactured, stored, and distributed in a way that meets high safety and quality standards.
The non-compliant ratings reportedly means that now the Canadian companies will no longer be able to import the drugs with active ingredients for the use in medications, unless extremally necessary.
According to sources familiar with the matter, Health Canada’s allegations are based on a review of information from an inspection report conducted by the U.S. Food and Drug Administration.
Reports state that the Chuannan manufacturing facility of Zhejiang Huahai Pharmaceuticals based in Linhai, China, manufactured valsartan, the active ingredient used in blood pressure and heart failure medications, was found to contain the impurities N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA). Assisted with FDA inspection, these medications were the subject of several recalls in Canada.
Health Canada, however, has been reported to continue to work with the U.S. FDA, European Medicines Agency, and other international regulatory partners to find the root cause of the issue and identify the next steps, including what measures should be taken in order to prevent the situation from reoccurring.
According to reliable reports, Health Canada will be assessing the impact of the non-compliant rating on the products in Canada. The assessment includes analyzing the possible effects on drugs supply and identifying measures pertaining to the supply concerns of the drug.
It has been reported that at this time, no products are being recalled or have been identified as medically necessary from the site. If at any point a safety concern has been identified, Health Canada will have the consent to take necessary actions and inform Canadians.