MUMBAI: With the recent USFDA directing the recall of Valsartan from the markets world over, an investigation has been initiated by the Drug Controller General of India against all those Indian companies who are importing raw material valsartan from Chinese manufacturer
Valsartan is a key raw material used in commonly used hypertension drugs and is manufactured by Chinese manufacturer Zhejiang Huahai Pharmaceuticals.
TOI reports that a showcause notice will be soon issued to both importers and manufacturer in this regard.
The step was taken in the wake of the recall of medicines containing valsartan in several developed countries recently, including the US, Germany, and Italy after it was found that an ingredient, N-nitrosodimethylamine (NDMA) used in valsartan’s manufacturing by this particular company carries the potential cancer risk.
Medical Dialogues had earlier reported that the U.S. Food and Drug Administration (FDA) alerted healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.
Medicines containing Valsartan are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke.Review of medicines containing Valsartan has been started by the regulatory agencies including the US Food and Drug Administration (USFDA) and European Medicines Agency.
The recall had been initiated by national authorities across the EU and certain companies in the US 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.
He further added that there would be a recall only if evidence is established; “we do not want to create panic (among patients).”
The Central Drugs Standard Control Organisation (CDSCO) swung into action on Thursday after it found that Zhejiang Huahai was registered with it.
An official told TOI that “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.”