Ranitidine Back in Spotlight Over Cancer Concerns

Ranitidine is a common medicine that was once widely used to treat heartburn, indigestion, and acid reflux. However, in recent years, its safety has come under question due to the discovery of a potentially cancer-causing chemical impurity in the drug.

What is NDMA, and Why Is It a Concern?

The chemical in question is N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen, meaning it could increase the risk of cancer if people are exposed to it over time. NDMA can sometimes form in medicines, especially under certain storage conditions or as they break down.

India's Drug Safety Authorities Take Action

During a recent meeting held on April 24, 2025, India’s top drug safety panel, the Drugs Technical Advisory Board (DTAB), discussed concerns about NDMA in ranitidine. The Board reviewed expert reports and agreed that more investigation is needed.

DTAB has now recommended two key steps:

The Indian Council of Medical Research (ICMR) should carry out a detailed study on the safety of ranitidine, focusing on the risks posed by NDMA.
A larger expert committee should be formed by the Central Drugs Standard Control Organisation (CDSCO) to study all factors related to NDMA formation, especially how the drug is stored and how stable it is over time.

What Does This Mean for Drug Manufacturers?

The Board stressed that manufacturers have a responsibility to monitor NDMA levels in their products. They may also need to take preventive steps, such as shortening the drug’s shelf life, to reduce the risk to patients.

Global Regulatory Actions on Ranitidine

Ranitidine has already faced major regulatory action in many countries:

September 2019: U.S. FDA finds NDMA in ranitidine and issues a safety alert.
October 2019: The European Medicines Agency (EMA) and Health Canada begin reviews.
April 2020: The U.S. FDA requests the complete withdrawal of ranitidine from the American market.
2020–2021: Countries like Canada, Germany, Switzerland, and France either banned or suspended ranitidine.
India (2020): The CDSCO alerted Indian drugmakers and asked for internal checks but did not ban the medicine outright.

Conclusion

With DTAB’s new recommendations, India may take stronger steps to reassess the use of ranitidine. The outcome will depend on further studies and expert evaluations, especially around how NDMA forms in the drug.

Source: Inputs from various media Sources

I’m a pharmacist with a strong background in health sciences. I hold a BSc from Delhi University and a pharmacy degree from PDM University. I write articles and daily health news while interviewing doctors to bring you the latest insights. In my free time, you’ll find me at the gym or lost in a sci-fi novel.