Latest news with #N-nitrosodimethylamine

Business Standard

Is your heartburn pill safe? Panel recommends banning ranitidine in India

The government may consider a nationwide ban on the widely used antacid ranitidine after an expert committee reportedly submitted a detailed report highlighting its potential cancer risks. According to a report by News18, which claims to have accessed the confidential document, the expert panel's findings may finally lead to regulatory action on a drug that has been under scrutiny since 2019. Panel recommends ranitidine suspension over NDMA cancer risk The report by the expert panel has been submitted to the apex body, the Drug Technical Advisory Board (DTAB), which advises the Drug Controller General of India on regulatory actions. According to the latest agenda document for the DTAB meeting, accessed by News18, the board is set to deliberate on a recommendation to suspend the manufacture, sale, and distribution of ranitidine in India. Half of ranitidine samples exceed global NDMA safety limits The report noted that, of the 42 samples of ranitidine tested at the Central Drug Laboratory in Kolkata, 21 were found to contain levels of N-nitrosodimethylamine (NDMA) impurities exceeding 0.32 parts per million. This surpasses the globally accepted threshold for the impurity, which is associated with a heightened risk of cancer upon prolonged exposure. What is ranitidine, and why was it so widely used? Ranitidine, first developed in 1981 in Europe by Glaxo Holdings Ltd, now part of GlaxoSmithKline (GSK) PLC, is sold over the counter under popular brand names such as Rantac, Zinetac, and Aciloc. It works by reducing stomach acid and is commonly used to relieve indigestion, heartburn, and treat gastroesophageal reflux disease (GERD) and ulcers of the stomach and intestines. Though banned in the United States, Europe, Australia, and several other countries, it has been a staple in Indian households for decades. Concerns over the drug arose after several international regulatory bodies—including the US Food and Drug Administration, European Medicines Agency, and Australia's Therapeutic Goods Administration—removed ranitidine from their markets over unacceptable levels of NDMA. In December 2024, the government informed the Rajya Sabha that the Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory body, had taken steps to address safety concerns surrounding NDMA in ranitidine. Ranitidine removed from essential medicines list in 2022 While India has thus far refrained from banning ranitidine, it was removed from the National List of Essential Medicines (NLEM) in 2022, and multiple safety advisories were issued. The News18 report now suggests that a formal ban may soon follow.