A Division Bench of the Delhi High Court on Wednesday issued notice on a Public Interest Litigation (PIL) seeking a time-bound and reasoned decision by the Centre on the safety of ranitidine. Ranitidine- most common antacid in India ove4 the recent years has been under the scanner widely used antacid. The matter is next scheduled for February 2027.
Acting Chief Justice Nitin Wasudeo Sambre and Justice Sanjay Sharma sought responses from the Union Ministry of Health and Family Welfare, the Central Drugs Standard Control Organisation (CDSCO), the Drugs Technical Advisory Board (DTAB) and the Indian Council of Medical Research (ICMR) on the petition.
What the petition seeks
The petition was filed by Dr Chandresh Jain, a qualified doctor and practising advocate. He has sought directions to the authorities to complete the pending regulatory review and publish a reasoned conclusion on the medication.
The plea does not seek an outright ban or a judicial determination on the drug’s scientific safety. Instead, it contends that the Union government should issue a regulatory warning if the expert committees recommend it.
“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.
Global scrutiny of ranitidine
Ranitidine, sold in India under brands such as Aciloc, Rantac, R Loc, Ranitin and Zinetac, came under international scrutiny in September 2019. The concern was the presence or formation of nitrosodimethylamine (NDMA), which the International Agency for Research on Cancer (IARC) classifies as a probable human carcinogen.
In April the following year, the US Food and Drug Administration asked manufacturers to withdraw all prescription and over-the-counter ranitidine products, while the European Medicines Agency recommended a precautionary suspension of the medicines in the EU.
However, the petition clarified that regulatory actions in other countries do not by themselves determine the safety of products currently sold in India, and therefore require a separate regulatory assessment.
The review that remains pending
Referring to the proceedings of the 92nd meeting of the DTAB held on April 24, 2025, the plea said the statutory advisory body had recommended setting up a larger committee, conducting an ICMR safety study, monitoring NDMA levels and considering risk-based measures, including a possible reduction in shelf life.
Subsequently, through an MOU issued in July the same year, the DCGI constituted a 16-member subcommittee and prescribed a 3-month deadline for the submission of its report. The plea highlighted that the deadline expired a year ago, but the report remained undisclosed. The plea further relied on an RTI reply furnished by the first appellate authority of CDSCO, which confirmed that the subcommittee’s report was still awaited and the matter continued to remain under review.