India’s drug controller has initiated an investigation against all companies importing key raw material valsartan for commonly used for 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.
Valsartan (trade name Diovan, Novartis International AG) is mainly used for treatment of high blood pressure, congestive heart failure, and after a heart attack. It is an angiotensin II receptor antagonist (commonly called an ARB, or angiotensin receptor blocker), that is selective for the type I (AT1) angiotensin receptor.
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