The National Health Commission (NHC) yesterday required medical institutions of all kinds and levels to stop using medicines containing the active ingredient valsartan produced by a domestic pharmaceutical company and to assist with related recalls.
Medical institutions must not use the recalled drugs containing impurity-affected valsartan during diagnosis and treatment, said a statement by the NHC, which added that medical personnel should take efficient measures to ensure medical safety.
The statement also asked medical institutions to keep local medical authorities and regulators informed about their work on assisting with the recall and halting the use of the recalled drugs.
The producer, Zhejiang Huahai Pharmaceutical Co. Ltd., halted shipments and launched voluntary recalls in domestic and foreign markets after it reported discovery of NDMA traces in its products for export to the drug regulator July 6, the country’s drug regulator said Sunday.
The company has taken needed measures in line with regulations, according to the State Drug Administration (SDA).
The company is a supplier of active pharmaceutical ingredients for valsartan.
On July 6, it reported to the drug regulator discovery of traces of N-nitrosodimethylamine (NDMA) in its products for export, a SDA spokesperson said, adding the company also revealed relevant information to the public.
Updated on the risk assessments issued by its global counterparts, the SDA has screened all of the country’s seven valsartan suppliers including Huahai for NDMA, qualifying products of the other six makers, according to the spokesperson.
NDMA is classified as a 2A carcinogen by European and multiple drug regulators, which means there is limited evidence proving it could cause cancer to humans, and measures including halting of sales and recalls are being taken as a precaution while the NDMA-laced drugs are not expected to pose severe risks to patients’ health, according to a statement from the SDA.(Xinhua)