Ranitidine Under Cancer Cloud: CDSCO Calls for Monitoring NDMA Levels, Shelf Life Cuts
New Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a directive to all State and Union Territory Drug Controllers regarding the safety of the antacid drug Ranitidine, in light of concerns over the presence of N-Nitrosodimethylamine (NDMA) impurity.
The official communication states that the matter has been under consideration “for quite some time now,” and that CDSCO has undertaken various measures in response from time to time.
In this regard, an expert committee was constituted via office memorandum dated 16 December 2024. The report of the committee was subsequently presented before the 92nd Drugs Technical Advisory Board (DTAB) meeting held on 28 April 2025, and the minutes of the meeting were enclosed with the directive.
Following detailed deliberation, the DTAB made three key recommendations:
That a larger committee be constituted to examine all aspects, including the storage conditions of Ranitidine;
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