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Ban on popular heartburn drug Ranitidine deferred amid cancer concerns
Some studies have found that Ranitidine can contain N-nitrosodimethylamine (NDMA), a chemical possibly linked to cancer. Despite global apprehension regarding the potential carcinogenic impurity, Indian authorities have opted not to ban the widely used heartburn medication.
Countries are banning Ranitidine. Why not India?
Ranitidine has been under scrutiny since 2019, when studies indicated that it could degrade over time to form NDMA, a probable human carcinogen. This led to its withdrawal in several countries, including the United States, European Union, and Australia.
Recently in India, an expert panel recommended the drug's suspension, but the Drug Advisory Committee decided instead to form a larger committee to evaluate all aspects. Following a meeting last week, the Drugs Technical Advisory Board (DTAB) also advised the Indian Council of Medical Research (ICMR) to conduct a study to assess Ranitidine's safety, The Economic Times reported.
What is Ranitidine, and why was it so widely used?
Developed in 1981 by Glaxo Holdings Ltd (now part of GlaxoSmithKline or GSK PLC), Ranitidine became one of the most widely used medications for managing stomach acid. Marketed under popular brands like Rantac, Zinetac, and Aciloc, it was readily available over the counter.
The drug was widely used to relieve indigestion and heartburn, and to treat conditions such as gastroesophageal reflux disease (GERD) and ulcers. Despite being banned in several countries, Ranitidine remained a staple in Indian households for decades.
Half of Ranitidine samples exceed global NDMA safety limits
The Central Drugs Standard Control Organisation (CDSCO) has taken measures to ensure patient safety. Last year, it formed a committee to examine NDMA-related safety concerns.
Ranitidine samples were sent to a government lab for analysis, and the results raised concern. Out of 42 samples tested at the Central Drug Laboratory in Kolkata, 21 were found to have NDMA levels above 0.32 parts per million (ppm)—exceeding the internationally accepted safety limit. Long-term exposure to such levels has been linked to increased cancer risk.
The controversy has sparked significant legal action globally. In the US, pharmaceutical companies such as GSK have faced numerous lawsuits alleging that Ranitidine caused cancer.
So, should you still be taking it?
Here's the honest answer: Talk to your doctor. If you're using Ranitidine occasionally and haven't experienced any issues, your doctor may still consider it acceptable. But if you're concerned, there are other alternatives that do not carry the same risk.
For now, Ranitidine remains legally available in India, though regulators are keeping it under close observation.
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