Valsartan Update

DCGI has enhanced checking of the Chinese bulk drug Valsartan at the ports after the American regulatory agency recalled Valsartan early this week over potential cancer risks.

The Drugs Controller General of India instructed the ports to examine each and every batch of the imported consignment of a Chinese bulk drug named Valsartan API, manufactured by Zhejiang Huahai Pharmaceuticals.

Earlier this week US FDA recalled Valsartan over potential cancer risk due to the presence of an impurity – a chemical known as NDMA or N-nitrosodimethylamine. Later European Medical Agency too issued an alert. So far, more than 20 countries recalled this Chinese API.