Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, has instructed drug controllers of all States and Union Territories to ensure that manufacturers under their jurisdiction monitor the presence of N-Nitrosodimethylamine(NDMA) - a potentially carcinogenic impurity – in the active pharmaceutical ingredient (API) and formulation of Ranitidine.

Ranitidine (previously sold under brand names like Zantac) is a medicine commonly used to reduce stomach acid production and treat conditions such as acid reflux, as well as stomach and intestinal ulcers. However, concerns about the presence of NDMA impurities above acceptable levels in some Ranitidine products led to its withdrawal from many markets, including the EU and the US.

“The issue related to the safety of Ranitidine drug due to the presence of NDMA impurity has been under consideration for quite some time now, and this office has taken various measures from time to time,” the DCGI said in a communication dated July 24.

An expert committee was constituted on 16 December 2024 to examine the issue, and its report was presented at the 92nd meeting of the Drugs Technical Advisory Board (DTAB) on April 28, 2025.

After detailed discussions, the DTAB recommended forming a larger committee to evaluate all aspects related to the safety of Ranitidine, including its storage conditions.

It also advised the Indian Council of Medical Research (ICMR) to conduct a study to assess the safety of the drug, considering the presence of NDMA impurity.

Furthermore, the DTAB recommended that manufacturers monitor the NDMA levels in the API/formulation and take risk-based measures such as reducing the shelf life.

Acting on these recommendations, the DCGI has asked all states and UT drug controllers to “direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life etc.”