A nationwide ban on ranitidine, one of India’s most widely used antacids, may soon be on the cards. A confidential report by an expert panel has flagged serious health risks associated with the drug, particularly its potential to cause cancer. Submitted to India’s Drug Technical Advisory Board (DTAB), the findings have triggered deliberations on whether to suspend the manufacture, sale, and distribution of the drug across the country.The Cancer Risk Behind RanitidineThe expert committee’s report, accessed by News18, highlights the presence of N-nitrosodimethylamine (NDMA) in several samples of ranitidine tested at the Central Drug Laboratory in Kolkata. NDMA is a chemical impurity classified as a probable human carcinogen. It is considered unsafe when consumed over a prolonged period in concentrations above global safety standards.Out of the 42 samples tested, 21 were found to contain NDMA levels above 0.32 parts per million (ppm)—the internationally accepted limit. This finding has raised red flags, as it confirms that nearly half the samples exceeded the safety threshold.What Is Ranitidine and Why Was It So Popular?Ranitidine, developed in 1981 by Glaxo Holdings Ltd (now GlaxoSmithKline), quickly became a go-to medication for millions around the world. In India, it is widely available over-the-counter under brand names like Rantac, Zinetac, and Aciloc. It is primarily used to reduce stomach acid and treat issues such as indigestion, heartburn, gastroesophageal reflux disease (GERD), and ulcers.Due to its affordability and easy accessibility, ranitidine became a staple in Indian households. Despite its ban in countries like the United States, Australia, and across Europe due to the NDMA contamination concerns, it has continued to be sold in India.Global Regulatory ResponseRanitidine first came under global scrutiny in 2019, when international regulators began detecting unsafe levels of NDMA in the drug. The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Australia’s Therapeutic Goods Administration (TGA) all pulled the medication from their respective markets.These agencies took the precautionary step of banning or recalling ranitidine to prevent long-term health risks in the population. They also recommended alternative treatments for acid reflux and ulcers, including other classes of antacids.India’s Position So FarWhile India did not impose an outright ban, the Central Drugs Standard Control Organisation (CDSCO)—the country’s apex drug regulator—acknowledged safety concerns as early as 2019. However, regulatory action remained limited. In December 2024, the government informed the Rajya Sabha that safety concerns were being addressed, though no concrete steps were taken until recently.A key development came in 2022, when ranitidine was removed from the National List of Essential Medicines (NLEM). This was seen as a soft warning to healthcare providers and the public. The CDSCO also issued multiple advisories but stopped short of a suspension or recall.What Happens Next?Now that the expert committee has submitted its findings to the DTAB, the board is expected to review the recommendation for suspending ranitidine. If the board agrees, India may finally join the list of countries that have banned the drug.In the meantime, doctors and pharmacists may begin advising patients to explore alternative treatments for acid-related disorders. Consumers, especially those with long-term use of ranitidine, are encouraged to consult their physicians and avoid self-medication.As regulatory bodies weigh their next move, public awareness and medical guidance will be key to ensuring a safe transition away from ranitidine.