Chinese drug under intensified scrutiny

Indian drug regulator 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.

Valsartan is a commonly used as a blood pressure drug, manufactured by a number of companies from imported active pharmaceutical ingredients. In fact, for most of the medicines made in India, the API is imported from China. Various Indian importers have been granted import licences for Valsartan.

However, earlier this week US Food and Drug Administration 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.

“All port officers are directed to closely monitor the import of Valsartan API manufactured by Zhejiang Huahai and draw the samples from every batch of imported consignment of the drug for laboratory testing including test for NDMA impurity,” DCGI says in its order issued on July 19.

According to the World Health Organisation, there is conclusive evidence that NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking water. The compound has been classified as a probable carcinogen by the International Agency for Research on Cancer – the specialised cancer wing of the WHO.