Delhi HC seeks Centre’s response on delay in safety review of acidity drug Ranitidine

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

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

In his petition, Jain contended that the safety of Ranitidine remained an unresolved concern since September 2019, when foreign drug regulators were alerted to the presence of NDMA, a probable human carcinogen, in products containing the drug.

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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 had not disclosed any final, reasoned or publicly available decision on the matter, the petition alleged.

The plea further stated that on April 24, 2025, the 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, the CDSCO maintained that the report was awaited and the matter remained under review.

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“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.