CDSCO Initiates Investigation into Ranitidine’s Carcinogenic Risks

The Central Drugs Standard Control Organisation (CDSCO) has launched a thorough investigation into the potential carcinogenic risks associated with Ranitidine, a widely used medication for acidity. This action follows directives from the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, who acted on recommendations from the Drugs Technical Advisory Board (DTAB). The DTAB’s 92nd meeting on April 28, 2025, highlighted concerns over N-Nitrosodimethylamine (NDMA), a probable human carcinogen found in Ranitidine.

Monitoring and Mitigation Measures for NDMA Levels

State and union territory drug regulators have been instructed to ensure that manufacturers of Ranitidine closely monitor NDMA levels in both the active pharmaceutical ingredient (API) and the drug’s formulations. The CDSCO has also advised reducing the shelf life of Ranitidine as a precautionary measure. Manufacturers are urged to adopt risk-based strategies, including modifying storage conditions and enhancing NDMA testing protocols throughout their supply chains.

Expert Committee Findings and Recommendations

An expert committee, formed in December of the previous year, submitted a report detailing impurity concerns related to Ranitidine. Based on these findings, the DTAB has called for a larger committee to examine all facets of the issue, including storage conditions that may contribute to NDMA formation. Additionally, the Indian Council of Medical Research (ICMR) has been recommended to conduct a study assessing the long-term safety of Ranitidine in light of NDMA presence.

Global Regulatory Scrutiny and Alternatives

Ranitidine’s association with NDMA has prompted global regulatory scrutiny over recent years. The drug was withdrawn from several markets, including the United States, after high levels of NDMA were detected in some samples. Dr. Abhishek Shankar, an oncologist at AIIMS Delhi, emphasized that Ranitidine falls under Group 2A carcinogens according to the International Agency for Research on Cancer (IARC), suggesting it should not be prescribed when safer alternatives like Famotidine and Pantoprazole are available.

Current Usage and Regulatory Actions

Despite reduced usage in metropolitan areas, Ranitidine continues to be prescribed in Tier 1 and Tier 2 cities, particularly at primary healthcare centers. Dr. Lohit Chauhan, a gastroenterologist at Max Dwarka, noted that while awareness of NDMA impurities is growing, there is a need for the DGCI to establish prescribed limits for NDMA levels in Ranitidine.