Last Updated on May 22, 2025 by The Health Master
Ranitidine
In a significant notification regarding the Drugs Technical Advisory Board (DTAB) of India, it seems that ranitidine (for indigestion, heartburn, and acid reflux) is under further investigation as India’s DTAB suggests that manufacturers within the country assess the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient and finished drug.
As many health authorities around the world have reacted to the drug in the last few years, this seems like the final step needed for a proper consensus to be created and enacted.
DTAB: Impurity Concerns in Ranitidine
On April 24, 2025, India’s DTAB met and acknowledged notification of ranitidine safety and continued concerns with NDMA impurity.
After assessing the expert committee report, the Drugs Technical Advisory Board believed more extensive findings were warranted.
Therefore, they recommended a larger committee be formed to assess every aspect of ranitidine, from manufacturing to stability, to ensure safety and efficacy.
Interestingly, some research shows that how one stores ranitidine could impact NDMA levels.
International concern
This advisory follows an international concern as well, as the USFDA banned ranitidine formulations and brands on September 13, 2020.
Thus, India’s DTAB is merely imparting caution to its countrymen based upon similar discoveries to prevent any more health disasters.
NDMA contamination in ranitidine is not a recent concern.
This contaminant was found approximately 5-6 years ago and prompted international regulatory agencies to step up in bigger markets, with the USFDA, UK, and EMA issuing advisories recommending that ranitidine be removed from their markets nearly 5 years prior to the Indian advisory.
Consideration of Availability of Other Drugs
The EMA also states in its observation that the primary purpose of ranitidine is to reduce gastric acid levels in patients and that there are alternative drugs to achieve this.
Therefore, one can deduce that this eventually contributed to the precautionary suspension.
Q. What is ranitidine used for?
A. Ranitidine is an antacid that treats indigestion, heartburn, and acid reflux by reducing the amount of acid in the stomach.
Q. What is NDMA?
A. NDMA is N-nitrosodimethylamine. It is a probable human carcinogen (based on animal studies) and occurs naturally in some foods and water.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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