The Centre has raised fresh health concerns over Ranitidine, a widely used anti-acidity drug, after potential cancer-causing impurities were flagged. The Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, has ordered a nationwide review of the medicine’s safety, following recommendations from the Drugs Technical Advisory Board (DTAB).
The Central Drugs Standard Control Organisation (CDSCO) has instructed all state and union territory drug regulators to ensure that manufacturers monitor levels of NDMA (N-nitrosodimethylamine), a probable human carcinogen, in both the active pharmaceutical ingredient (API) and final formulations of Ranitidine. It has also recommended reducing the drug’s shelf life as a precaution.
The directive follows the DTAB’s 92nd meeting held on April 28, 2025, where it reviewed findings from an expert panel formed last December to study the presence of NDMA in Ranitidine. The Board has now called for a larger committee to investigate contributing factors such as storage conditions and manufacturing practices.
Additionally, the Board has recommended that the Indian Council of Medical Research (ICMR) undertake a study to assess Ranitidine’s long-term safety in light of potential NDMA contamination.
Manufacturers have been asked to adopt risk-based approaches, including stricter testing protocols, revised storage guidelines, and shorter shelf life limits to reduce the risk of NDMA formation.
Ranitidine was previously pulled from several global markets, including the United States, after high NDMA levels were detected. NDMA has been under international scrutiny in recent years due to its presence in several common medications and its classification as a probable carcinogen.
