HC seeks replies on plea to speed up Ranitidine safety review

The Delhi high court on Wednesday issued notice in a petition seeking directions to the Centre and its drug regulatory authorities to complete, within a stipulated time frame, the pending safety review of Ranitidine, a medication commonly used to treat acidity and reduce stomach acid.

A bench of acting chief justice Nitin Sambre and justice Sanjay Sharma sought responses from the Centre, the Central Drugs Standard Control Organisation (CDSCO), the Drugs Technical Advisory Board (DTAB) and the Indian Council of Medical Research (ICMR) in a petition filed by Chandresh Jain, an advocate.

In his petition, Jain contended that the safety of Ranitidine has remained an unresolved concern since September 2019, when foreign drug regulators were alerted to the presence of N-nitrosodimethylamine (NDMA)—a probable human carcinogen—in products containing the drug. He submitted that the United States, the European Union and Australia had each taken regulatory action in 2020, albeit under different legal frameworks. However, despite examining the issue for several years, India’s drug regulator has not disclosed any final, reasoned or publicly available decision on the matter, the petition alleged.

The plea further stated that on April 24, 2025, DTAB referred the matter to a further committee and an ICMR study. It added that the three-month deadline for submitting the report, fixed by the Union government on July 24, 2025, expired around October 24, 2025.

However, as recently as October 7, 2026, CDSCO maintained that the report was awaited and the matter remained under review.

“The medicine is cheap, widely available and often bought without a prescription, so the people who bear the burden of an unresolved question are largely those least able to find or pay for other care. Regulators in the United States, the European Union, Australia, Canada, the United Kingdom and Singapore each reached some decision on Ranitidine after the 2019 alerts,” the petition said.