New Delhi: Supplies of the active ingredient of Valsartan, a commonly used blood pressure drug imported from China are under the scanner of Indian drug regulatory authorities after the US regulator warned of contamination from a cancer-causing impurity.
The Drug Controller General of India (DCGI) on Thursday directed ports in India to ensure safety of the supplies of the drug imported from China before they enter the country, two people aware of the matter said.
The USFDA recalled Valsartan over potential cancer risks early this week. The European Medicines Agency (EMA) has also issued an alert over the supplies of active ingredient of Valsartan produced by Zhejiang Huahai Pharmaceutical Company, based in eastern China and listed on Shanghai’s stock exchange.
“To ensure that such product doesn’t enter the country, the ports have been alerted. The officers will test the product for its safety," said one of the two people, requesting anonymity.
So far about 22 countries have recalled Valsartan, alleged to be containing a chemical NDMA (N-nitrosodimethylamine) impurity that poses a potential cancer risk.
NDMA is an organic carcinogen chemical commonly used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct of some pesticide manufacturing, the manufacture of rubber tyres and fish processing.
Doctors in India are on high alert and advise discontinuation of the drug citing safety concerns. “Valsartan has been important blood pressure drug with proven efficacy for patients with diabetes and heart disease. This unfortunate contamination means we should immediately discontinue it and replace with safer alternatives. Physicians should especially be careful since it mostly comes in combination with other drugs in India," said Dr Anoop Misra, chairman, Fortis C-DOC.
Novartis India, one of the companies that manufacture the product says there is nothing for Indian patients to be concerned about. “The affected products are not marketed in India and hence no impact in the country. Novartis initiated the recall of defined specific batches of Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets because of a confirmed impurity above the typically established limit. This is in line with our commitment to meeting the highest quality standards for all of our marketed products and in agreement with the local health authorities. The impurity was identified as NDMA. No other Sandoz or Novartis products have been affected by this recall and both Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets are not marketed in India. All other Novartis products containing valsartan use another API source with a different way of producing it, where in the relevant synthesis process this specific impurity is not formed," said the Novartis spokesperson.