The Central Drugs Standard Control Organisation(CDSCO) issued a circular for Nitrosamines in Ranitidine

NDMA, also known as N-Nitrosodimethylamine, and other nitrosamines are significant concerns for the pharmaceutical industry. USFDA and other health agencies, especially in strict regulatory markets (SRM), require nitrosamine risk assessments in the dossiers submitted to the respective authorities. 

Many countries have banned the drug products which would have the potential to form nitrosamines during the manufacturing process or storage. Ranitidine is one of them.


CDSCO has also recently issued a circular on 12 July 2025. The circular can be found here. 


The circular addresses concerns about NDMA impurity in Ranitidine. It informs State/UT Drug Controllers of recommendations from the Drugs Technical Advisory Board (DTAB), following a report by an expert committee. 


The DTAB recommends forming a larger committee to examine all aspects of Ranitidine, the ICMR (Indian Council of Medical Research) conducting a safety assessment on NDMA impurity, and manufacturers monitoring NDMA levels in Ranitidine while considering risk-based measures like reducing shelf life. 


In short, the circular requests Drug Controllers to direct manufacturers to monitor NDMA levels and take necessary risk-based actions.
Location: Mumbai, Maharashtra, India

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