No plan to ban heartburn drug Ranitidine, says Health Ministry

There are no plans to ban the manufacture, distribution, or sale of Ranitidine, a common medication for reducing stomach acid, Minister of State for Health Anupriya Patel informed the Rajya Sabha on Tuesday.

Responding to concerns about the presence of N-nitrosodimethylamine (NDMA), a potentially harmful impurity, in Ranitidine, Patel stated that India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has taken steps to address safety concerns.

These include testing Ranitidine samples for NDMA, instructing manufacturers to verify their products, and ensuring compliance with safety standards.

The CDSCO has also directed its zonal offices to collect and analyse samples to monitor NDMA levels in Ranitidine formulations. Besides this, the Indian Pharmacopoeia Commission has included a chapter on Nitrosamine Impurities in the 9th edition of the Indian Pharmacopoeia (IP) 2022.

This provides methods for analysing impurities like NDMA and establishes acceptable



intake limits.

Patel clarified that while the government has reviewed international findings from bodies such as the US Food and Drugs Administration and European Medicines Agency (EMA) regarding NDMA in Ranitidine, no prohibition under Section 26A of the Drugs and Cosmetics Act, 1940, is being considered at this time.

The measures reflect ongoing efforts by health authorities to ensure patient safety while maintaining the availability of essential medications.

Recently, UK pharmaceutical giant GSK, the manufacturer of Ranitidine, agreed to pay up to $2.2 billion to settle 93% of US state court lawsuits related to Zantac, a discontinued version of Ranitidine, resolving about 80,000 cases by mid-2025.

This followed after Valisure, an American pharmacy, raised concerns about how Zantac contained high amounts of N-nitrosodimethylamine (NDMA), which can cause cancer.

The drug is banned in the US. In India, it is widely sold under names like Aciloc, Rantac and Zinetac.