Is Ranitidine banned in India?

Ranitidine is the acid-reducing drug behind Rantac, Aciloc and Zinetac, and it is the clearest case in India of a medicine that is widely believed to be banned but is not.

The concern is a contaminant. In 2019 regulators found that ranitidine can degrade into N-nitrosodimethylamine (NDMA), a probable human carcinogen, and that the amount rises with storage time and temperature. The United States withdrew all ranitidine products in April 2020; the European Union suspended them the same year. India instead ordered testing. The Central Drugs Laboratory in Kolkata found that 21 of 42 samples exceeded 0.32 parts per million of NDMA, the acceptable-intake threshold, and the drug was dropped from the National List of Essential Medicines in 2022.

A ban was placed before the Drugs Technical Advisory Board in April 2025. The Board deferred it and asked the Indian Council of Medical Research to study NDMA formation in Indian conditions and the associated risk. Business Standard reported the deferral on 1 May 2025. In July 2025 the DCGI ordered a nationwide safety review: Outlook reported on 28 July 2025 that CDSCO told states to make manufacturers monitor NDMA in the active ingredient and the finished product, and recommended a shorter shelf life. No Section 26A notification has followed, so ranitidine remains licensed and on sale. A ranitidine oral solution batch appeared in the June 2026 quality alert, which is a batch-specific finding.

Patients on ranitidine have a real question to ask their doctor: whether famotidine or a proton-pump inhibitor would be a better choice. That is a clinical decision, not a regulatory one.