The recall of blood pressure drug, Valsartan, over concerns that it contains cancer-causing impurity has prompted swift action in India. While chemists are already facing a shortage of the commonly used medicine, the drug regulatory authority has told state agencies to be alert so that the drug does not enter the country.
The recall list of Valsartan has widened since July 2018 when the US Food and Drug Administration (FDA) first announced that batches of the drug might be tainted with the cancer causing agent, a chemical called N-nitrosodiethylamine (NDEA). On 28 January, Aurobindo Pharma’s US arm, Aurobindo Pharma USA Inc., recalled nearly 4.95 lakh bottles of Valsartan from the US market, which was followed by a recall in the first week of January.
Ahmedabad-based Torrent Pharmaceuticals recalled two lots of same drug with the brand name Losartan in December. In January, it recalled six more lots of the same drug after unacceptable amounts of NDEA were found in the product. NDEA has been classified as a probable human carcinogen.
In December, Torrent Pharmaceuticals had issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns. In November, Mylan Pharmaceuticals had also issued a voluntary recall of some of its Valsartan products for the same reason.
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 the Shanghai stock exchange.
Amid the ongoing recalls and investigations into the impurities, chemists in India are already facing the heat. Popular blood pressure drug Valent by Lupin has been unavailable for the last two months, said Ajay Pal Gupta, adviser, Retailer and Distributor Chemists Association (RDCA). An email sent to Lupin did not elicit any response till press time.
The Drug Controller General of India has directed Indian ports to keep a check on supplies of the drug imported from China before they enter the country. On Thursday, the drug regulatory authorities also asked its zonal office in Hyderabad to verify steps being taken by Aurobindo Pharma’s India office to make sure that the product is not sold in India, two people aware of the matter said. Aurobindo Pharma did not respond to an email sent on Tuesday.
So far, about 22 countries have recalled Valsartan. In August last year, the FDA found it containing NDMA (N-nitrosodimethylamine) in excess of acceptable levels from samples tested from Hetero Labs in India. “Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang," the FDA said.
Doctors in India said the product should be discontinued immediately. “Valsartan has been an important blood pressure drug. The contamination means we should immediately discontinue it and replace with safer alternatives," said Dr Anoop Misra, chairman, Fortis C-DOC.
“We are facing some shortage but fortunately there are safer alternatives available," said JPS Sawhney, cardiologist, Sir Ganga Ram hospital.
Novartis India said there was nothing for Indian patients to be concerned about. “The affected products are not marketed in India and hence (there’s) 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... 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 a Novartis spokesperson.