Law & Justice

Delhi High Court Seeks Answers on Ranitidine Safety Review Deadline

By Shruti Kakkar

The Delhi High Court issued notice on Wednesday in a petition seeking directions to the Centre and its drug regulatory authorities to complete the pending safety review of Ranitidine within a stipulated time frame. Acting Chief Justice Nitin Sambre and Justice Sanjay Sharma asked for 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). The petition, filed by advocate Chandresh Jain, argues that the safety of Ranitidine has remained unresolved since September 2019, when foreign regulators were alerted to the presence of N‑nitrosodimethylamine (NDMA), a probable human carcinogen, in products containing the drug. Jain notes that the United States, the European Union and Australia took regulatory action in 2020 under different legal frameworks, but India’s drug regulator has not issued a final, reasoned or publicly available decision. The petition states that on 24 April 2025, DTAB referred the matter to a further committee and an ICMR study. A three‑month deadline for submitting the report, set by the Union government on 24 July 2025, expired around 24 October 2025. As of 7 October 2026, CDSCO maintained that the report was awaited and the matter remained under review. The petition highlights that the medicine is cheap, widely available and often bought without a prescription, meaning that the people most affected by the unresolved question are 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 case will be heard next in February.