Indian drug regulator flags cancer-causing chemical in Ranitidine

The Central Drugs Standard Control Organisation (CDSCO) has instructed all state and union territory drug regulators to ensure that manufacturers of Ranitidine--an acidity medication widely used in India--monitor levels of N-Nitrosodimethylamine (NDMA), a potentially cancer-causing impurity, in both the active pharmaceutical ingredient (API) and final formulations of the drug.

As a precaution, CDSCO has also advised reducing the shelf life of Ranitidine. This directive follows a recommendation from the Drugs Technical Advisory Board (DTAB) during its 92nd meeting on April 28, 2025. The decision was announced by the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi.

The DTAB's recommendation is based on a report submitted by an expert committee formed in December 2024 to examine concerns about NDMA contamination in Ranitidine. The Board has now proposed forming a larger committee to evaluate additional factors, including storage conditions that may contribute to NDMA formation.

Furthermore, the DTAB has urged the Indian Council of Medical Research (ICMR) to conduct a study assessing the long-term safety of Ranitidine in the context of NDMA exposure. Manufacturers have been instructed to implement risk-based strategies, including reducing shelf life, modifying storage guidelines, and strengthening NDMA testing protocols throughout the supply chain.

NDMA is classified as a Group 2A carcinogen by the International Agency for Research on Cancer (IARC), indicating it is a probable human carcinogen. Its presence in medications has been under global regulatory scrutiny, particularly after high NDMA levels were detected in some Ranitidine samples, leading to the drug’s withdrawal from markets such as the United States.