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New Delhi: A US online pharmacy has flagged drugs, sold in India to treat hypertension and to prevent cardiac arrest, as containing high levels of cancer-causing substances. 

The online pharmacy, Valisure, has now requested the US Food and Drug Administration (FDA) to check the drug Valembic, sold by Swiss drug maker Novartis, and Diovan, sold by the Indian pharmaceutical firm Alembic, for carcinogens.   

The FDA, the American health regulator, is reviewing the request. 

Both the drugs are popular anti-blood pressure pills in India and contain the component ‘valsartan’.

Cardiovascular diseases are the top reasons for deaths in India where one in every eight person suffers from high blood pressure. And sartan — valsartan and losartan — containing drugs are prescribed to a large number of patients in India to dilate their blood vessels, keep blood pressure in check and hence, reduce the load on the heart.   

But the drugs have been under the scanner in the US for repeatedly failing the test for carcinogens.  Just on 25 June, the Mumbai-based drugmaker, MacLeods Pharmaceuticals, announced the recall of its anti-hypertensive ‘losartan’-based pills. The FDA found that the pills contained the impurity NDMA (N-Nitroso-N-methyl-4-aminobutyric acid) above the acceptable limit of 9.82 ppm set by the American health regulator.


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“Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out,” reads MacLeod’s written notice on FDA’s website.

The company sells the drug under the brand name ‘Omnitan’ in India. It has, however, not recalled nor issued an advisory on ‘losartan and valsartan contaminations’ in India.

“We do the regular audits on these drug units and check the samples.  The medicines are safe enough,” a senior official India’s apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), told ThePrint. “Further inspections have been planned and we will be testing the drugs based on US’ reports.”

The FDA too has advised patients not to discontinue the medicine without taking the opinion of a doctor. “FDA reminds patients taking recalled ARBs to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition,” it said on 26 June.

A Novartis spokesperson told ThePrint via email that the firm’s valsartan products are safe. “Novartis’ Pharma valsartan family of products fully complies with relevant regulatory requirements in terms of quality and safety,” the spokesperson said.

“Patient safety is at the heart of what we do,” the spokesperson added. “That is why we have a strong team, including physicians, pharmacists, scientists and other healthcare professionals, dedicated to ensuring the quality and safety of all our medicines.”

ThePrint contacted Alembic and Macleods through email and received no response. The story will be updated if and when they do respond.

Not the first recall

In February, this year, Macleods Pharmaceuticals had recalled the same product in the US for the same reason.  In April, the Israeli drug maker Teva Pharmaceuticals had also announced the voluntary recall of the same drug after finding the same impurity, NMBA exceeding the benchmark.


Also read: India’s copycat drugs could do serious harm to patient health, says US pharma lobby


Despite several drug recalls in the United States, no recalls or advisory has been issued in India so far. 

Last year, however, the CDSCO had banned the import of the ingredient Valsartan from the Chinese company, Zhejiang Huahai Pharmaceuticals, which it claimed was the root of the contamination. The Chinese firm was supplying the contaminated raw material to several firms including India’s Hetero Labs.

  • The copy has been updated to incorporate Novartis’ version.

 

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