In a move to address ongoing safety concerns surrounding the widely used antacid Ranitidine, the Central Government has issued a directive to all State and Union Territory Drug Controllers, calling for enhanced oversight of the drug’s quality due to the presence of N-Nitrosodimethylamine (NDMA) impurity. This notice was issued on July 24, 2025.
The notice follows deliberations by the Drugs Technical Advisory Board (DTAB), highlighting findings from an expert committee constituted via official memorandum on December 16, 2024. The committee’s report was reviewed during the 92nd DTAB meeting held on April 28, 2025.
After thorough discussion, the DTAB recommended a series of key measures:
- Constitution of a larger oversight committee to examine all aspects of Ranitidine safety, including its storage conditions.
- A potential study by the Indian Council of Medical Research (ICMR) to reassess the safety of the drug in light of the NDMA impurity.
- Directives to manufacturers to monitor NDMA levels in both the Active Pharmaceutical Ingredient (API) and final formulations of Ranitidine, along with adoption of risk-based measures such as reducing the drug’s shelf life.
In light of these recommendations, State and UT Drug Controllers have been instructed to ensure that manufacturers under their jurisdiction closely monitor NDMA levels and implement the suggested safety steps.
NDMA is classified as a probable human carcinogen, and its detection in several pharmaceutical products—including Ranitidine—has prompted global regulatory action in recent years. This latest advisory signals India’s continued vigilance and multi-agency coordination in safeguarding public health.