Last Updated on August 9, 2025 by The Health Master
Ranitidine
Ranitidine Under Scrutiny Over NDMA Concerns
The Central Drugs Standard Control Organization (CDSCO) has issued a letter to all State Drug Controllers as well as Union Territory Drug Controllers to address safety concerns regarding Ranitidine, the most common antacid drug.
The main aim of this letter is regarding the presence of N-Nitrosodimethylamine (NDMA) impurity, a potential carcinogen, in the drug’s formulations.
This decisive move by the Government of India, detailed in a circular dated July 24, 2025, shows the commitment towards public health and drug safety standards.
DTAB’s Recommendations:
The presence of NDMA impurity in Ranitidine has been a subject of careful consideration by Indian drug authorities for a long time.
Keeping in view the seriousness of the situation, an expert committee was established on December 16, 2024, to delve into the aspects of this issue.
The findings and recommendations of this expert committee were subsequently presented and thoroughly reviewed during the 92nd meeting of the Drugs Technical Advisory Board (DTAB) held on April 24, 2025.
Key recommendations by DTAB:
Formation of a Broader Committee:
A larger, more encompassing committee must be formed to investigate all aspects of Ranitidine’s safety, with optimal storage conditions.
This proactive approach aims to uncover critical factors contributing to NDMA formation.
ICMR Study on Ranitidine Safety:
The Indian Council of Medical Research (ICMR), a premier body for biomedical research, has been urged to conduct a detailed study to assess the safety profile of Ranitidine, keeping in view the presence and levels of NDMA impurity.
This scientific investigation will provide important data for future regulatory decisions.
Manufacturer Accountability:
An important directive for pharmaceutical manufacturers urging for rigorous monitoring of NDMA levels in both the Active Pharmaceutical Ingredient (API) and the final drug formulation.
Furthermore, pharma manufacturers are directed to implement immediate risk-based measures, like reducing the shelf life of Ranitidine drugs, to minimize potential patient exposure to NDMA.
Impact on Manufacturers
The Drugs Controller General (India), Dr. Rajeev Singh Raghuvanshi, has urged all State Drug Controllers as well as UT Drug Controllers to direct pharma manufacturers within their jurisdiction to immediately comply with the new guidelines.
Guidelines are as under:
Enhanced Testing Protocols:
Pharma manufacturers must build up their testing and quality control procedures to accurately identify NDMA levels in every batch of Ranitidine drug.
Proactive Risk Management:
Beyond testing, a proactive approach to risk management is expected, which may involve re-evaluating and potentially shortening the expiry dates of Ranitidine drugs to ensure consumer safety.
Q: What is meant by NDMA?
A: NDMA is “N-Nitrosodimethylamine.” NDMA is a contaminant that can be found in water and foods, including cured meats, dairy products, and vegetables. It is also defined as a human carcinogen, which could cause cancer in humans.
Q: What is the reason of presence of NDMA in Ranitidine?
A: The presence of NDMA in Ranitidine is potentially due to the instability of the ranitidine molecule itself, which has a tendency to degrade over time and under certain storage conditions to form NDMA. Manufacturing processes and excipients may also be a reason for the formation of NDMA.
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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