Health ministry says no plans to ban heartburn drug ranitidine
The Health Ministry has said it has no plans to ban ranitidine despite concerns over NDMA impurities being linked to some cancers. However, CDSCO has implemented measures to ensure security.
Minister of State for Health Anupriya Patel informed the Rajya Sabha on Tuesday that there is no plan to ban the manufacture, distribution or sale of ranitidine, a common drug to reduce stomach acid.
Responding to concerns about the presence of a potentially harmful impurity, N-nitrosomethylamine (NDMA), in ranitidine, Patel said that India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), has issued a new drug to address safety concerns. Steps have been taken.
These include testing ranitidine samples for NDMA, directing manufacturers to verify their products, and ensuring compliance with safety standards.
CDSCO has also directed its regional offices to collect and analyze samples to monitor NDMA levels in ranitidine formulations. Furthermore, the Indian Pharmacopoeia Commission has included a chapter on Nitrosamine impurities in the 9th edition of the Indian Pharmacopoeia (IP) 2022.
It provides methods to analyze impurities such as NDMA and establishes acceptable intake limits.
Patel clarified that although the government has reviewed the international findings of bodies such as the US Food and Drug Administration and the European Medicines Agency (EMA) regarding NDMA in ranitidine, the NDMA under Section 26A of the Drugs and Cosmetics Act, 1940 No restrictions are being considered. This time.
These measures reflect ongoing efforts by health authorities to ensure patient safety while maintaining the availability of essential medicines.
Recently, ranitidine’s manufacturer, UK pharmaceutical giant GSK, agreed to pay up to $2.2 billion to settle 93% of US state court lawsuits related to Zantac, a discontinued version of ranitidine, and about 80,000 by mid-2025. Matters resolved.
This followed concerns raised by Valisure, a US pharmacy, over how Zantac contained high amounts of N-nitrosomethylamine (NDMA), which can cause cancer.
This medicine is banned in America. In India it is widely sold under the names Aciloc, Rantac and Zinetac.
