Ranitidine Remains Unrestricted Amid Safety Scrutiny

The Indian government currently has no plans to ban Ranitidine, a stomach acid reducer, despite international concerns about impurities. Actions include testing and communication with drug manufacturers. The Indian Pharmacopoeia Commission outlines impurity analysis methods in its latest edition.

The Indian Government has confirmed that there are no current plans to ban Ranitidine, a medication used to treat stomach acid issues, despite international concerns regarding impurities. Minister of State for Health, Anupriya Patel, addressed the issue in the Rajya Sabha, clarifying the State’s position.

Amidst worries raised by international regulatory bodies, such as the USFDA and EMA, about N-nitrosodimethylamine (NDMA) presence in Ranitidine, the Central Drugs Standard Control Organisation has been taking steps to assure public safety. These measures entail sample testing and communication with the State Drugs Controllers to ensure manufacturers test their products thoroughly.

The Indian Pharmacopoeia Commission has also added a General chapter on Nitrosamine Impurities detailing their analysis in its latest edition, which aims to guide local producers in managing the acceptable intake limits of such impurities.