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While some batches of drugs manufactured by India’s Hetero Labs Ltd are now on the US Food and Drug Administration (FDA) list of valsartan products under recall over a cancer-causing chemical, there is no need for Indian patients to go into panic mode now. Though valsartan is a key component in various life-saving drugs sold in the domestic market, many Indian companies obtain the bulk drug manufactured by a different process which is found to be safe, say industry experts.
Valsartan, commonly used as a blood pressure drug, is manufactured by a number of firms in India from imported active pharmaceutical ingredients from China. The FDA had recalled supplies of valsartan active pharmaceutical ingredient (API) produced by Zhejiang Huahai Pharmaceutical Company based in eastern China. Many Indian firms have licence to import this API.
Following the FDA move, the Central Drugs Standard Control Organisation is keeping a close watch on import of valsartan API from China at ports across the country. More than 20 countries have already recalled Chinese valsartan, which is alleged to contain the chemical N-nitrosodimethylamine (NDMA) impurity which has potential carcinogen. The Drugs Controller General of India (DCGI) has ordered drug inspectors at port offices to inspect import consignments manufactured by Zhejiang Huahai and draw the samples from every batch of the drug for laboratory testing including test for NDMA impurity.
“We welcome the national regulator’s action as a precautionary measure. But consumers should keep in mind that there are many pharmaceutical products containing valsartan and they all are not tainted. The impurity was found in drugs produced through a specific manufacturing process. Moreover, there are many substitutes for this medication. There is no cause for concern,” Federation of Pharma Entrepreneurs (FOPE) president BR Sikri told Pharmabiz.
NDMA is an organic carcinogen which is present at very low levels in many foodstuffs, especially cooked, smoked or cured items. It can be produced as a byproduct of certain chemical reactions. The FDA has said in a statement that the amount of NDMA found in API of Hetero Labs “exceeds acceptable levels, although it is generally lower than the amount discovered in the API manufactured by Zhejiang”.
Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies. Diovan and generic versions made by several companies are not included in the recall. According to industry sources, many Indian companies, for instance Aurobindo Pharma Limited, have clearance to manufacture and market valsartan-containing drugs.
In a statement, the Swiss company said that the amount of NDMA found in valsartan API was much lower than the cumulative endogenous production and its usual external exposure and there was no certainty as to how much the contaminant might potentially increase cancer risk in humans.
The FDA statement has stressed that the NDMA presence was “unexpected”. "The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured," it said.
Many medical professionals also warn against unnecessary panic. “We should make sure that the present crisis won’t undermine people’s faith in this drug. The contaminant is the issue. Valsartan remains an effective medication to treat high blood pressure and heart failure. Even in the US, patients on the heart failure combo drug Entresto, which contains valsartan, is not affected by the recall," a Delhi-based senior cardiologist pointed out.
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