Last Updated on May 13, 2025 by The Health Master
Ranitidine
However, India’s foremost drug advisory body has taken a different approach after increasing global reports and strong recommendations by its internal panel to cease marketing and subsequent sale regarding the Ranitidine.
India’s Drugs Technical Advisory Board (DTAB) recently convened and instead of enacting a cease and desist, it chose to form a “larger committee” to investigate the drug further across the board.
Ranitidine is an antacid that treats heartburn and excess acidity and is sold over the counter in India.
It came under international scrutiny after nitrosodimethylamine (NDMA)—the contaminant with the presumed human carcinogen classification— was discovered.
DTAB Recommendations Follow up Committee Report Findings
The DTAB’s recommendations are subsequent to an expert committee’s findings constituted to review the Ranitidine NDMA safety issue.
The expert committee assessed international regulatory authority actions and tested 42 samples of Ranitidine drugs available in India at Central Drug Laboratory, Kolkata, a government laboratory.
21 samples were found with NDMA impurity higher than 0.32 PPM.
0.32 PPM is the determined acceptable threshold by international regulatory authorities after which, with exposure above 0.32 PPM, patients are determined to have increased lifetime cancer risks.
Thus, the expert committee compared findings and actions from international regulatory authorities about the drug Ranitidine and its findings relative to international response and unanimously decided that India’s population should not be any different, stating “of suspension of the drug Ranitidine for manufacture, sale, and distribution in the country.”
The committee also recommended that subjects currently taking Ranitidine should consult their physician for alternative therapies.
International Regulators Went Ahead of India
To make matters worse, international regulators like the USFDA, EMA, and Australia’s TGA have already suspended Ranitidine from their markets or withdrawn the drug after finding similar NDMA presence.
So when new regulators—and international ones—start linking a molecule to carcinogenicity, it becomes even more difficult for Indian regulators to ignore the findings.
DTAB Suggests Additional Study: ICMR to Assess Safety of Ranitidine
In addition to forming a larger, new committee, DTAB also suggested ICMR assess the safety of Ranitidine through a study yet to be disclosed in terms of time and scope.
Q. What is Ranitidine?
A. A medication for heartburn, acid indigestion, stomach ulcers and other conditions due to excess stomach acid.
Q. Why is Ranitidine of concern?
A. Due to the discovery of an impurity called N-nitrosodimethylamine (NDMA), a probable human carcinogen.
Q. What is NDMA?
A. A substance that can be formed unintentionally during drug manufacture; it’s a probable human carcinogen based on studies in animals.
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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