Latest news with #N-nitrosodimethylamine
Time of India
3 days ago
- Health
- Time of India
Monitor NDMA levels in antacid Ranitidine: Drugs body CDSCO
NEW DELHI: Drug controllers of all states and UTs have been asked by Central Drugs Standard Control Organisation (CDSCO) to direct manufacturers under their jurisdiction to monitor levels of NDMA in the active pharmaceutical ingredient or drug formulation of Ranitidine, a commonly used antacid. NDMA (N-nitrosodimethylamine) is a chemical which has been recognised as a probable carcinogen by International Agency for Research on Cancer (IARC), reports Durgesh Nandan Jha. CDSCO's decision came after reports of NDMA impurity in the medicine. An expert panel was appointed to deliberate on the concern in Dec last year. Sources said the the committee's recommendations were deliberated in a meeting of Drug Technical Advisory Body recently. DTAB recommended that a larger committee be constituted to look into all aspects, including storage conditions of Ranitidine, and also suggested that the Indian Council of Medical Research undertake a study to assess the drug's safety in addition to directing manufacturers to monitor NDMA levels in the drug and, if required, take risk-based measures such as reducing the shelf life.
&w=3840&q=100)
Business Standard
23-04-2025
- Health
- 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.
