MUMBAI: India’s drug controller has initiated an investigation on Thursday against all companies importing key raw material valsartan for commonly used hypertension drugs from Chinese manufacturer Zhejiang Huahai Pharmaceuticals.
This comes in the wake of recall of medicines containing valsartan in several developed countries recently, including the US, Germany and Italy after reports that an ingredient used in valsartin’s manufacturing by this particular company carries “potential cancer risk”.
Both the importer and the Chinese manufacturer, Zhejiang Huahai Pharmaceuticals, will be issued a show-cause notice soon.
Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke.
Regulatory agencies, including US Food and Drug Administration and European Medicines Agency, started a review of medicines containing the active substance valsartan.
However, even as the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.
Certain companies in the US are also voluntarily pulling out the drug from the market. Hypertension is one of the most common lifestyle diseases in India, with one in three adults with high blood pressure.
“All port offices are being issued orders to check each consignment being imported into the country, and send each batch for testing the key input in our labs”, DGCI S Eswara Reddy told TOI, ruling out a recall as yet.
There would be a recall only if evidence is established; we do not want to create panic (among patients), he said.
The Central Drugs Standard Control Organisation swung into action on Thursday after it found that Zhejiang Huahai was registered with it.
Typically, the import is carried out by an importer who may also appoint agents for importing the product. The probe will cover all agents who hold the licence for the API, and all quantities imported into the country, the official said.
