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, a widely used acidity medication, amid concerns over the possible presence of a cancer-linked impurity in the drug. A Division Bench of 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).

Source: Tripura Times (wire report)

The petition was filed by Dr Chandresh Jain, a qualified doctor and practising advocate. It does not seek an outright ban on Ranitidine or a judicial determination of its scientific safety; it asks the authorities to complete the pending regulatory review and publish a reasoned conclusion within a fixed timeframe, arguing that the government's own review has remained inconclusive despite expert committee recommendations and an expired reporting deadline.

Source: Nation Press

2019Year Ranitidine came under international scrutiny over NDMA, classed by IARC as a probable human carcinogen
16Members of the DCGI sub-committee constituted on July 24, 2025 to review the drug's safety
3 monthsDeadline given to that sub-committee - it expired around October 24, 2025 with the report still undisclosed
30+ yearsPeriod Ranitidine has been marketed in India, under brands including Aciloc, Rantac and Zinetac

A review that has outlived its own deadline

The plea refers to the 92nd meeting of the DTAB, held on April 24, 2025, which recommended constituting a larger committee, conducting an ICMR safety study, monitoring NDMA levels and considering risk-based measures, including a possible reduction in shelf life. Acting on that, the Drugs Controller General of India (DCGI) issued an office memorandum on July 24, 2025 constituting a 16-member sub-committee with a three-month deadline to submit its report.

Source: Tripura Times (wire report)

That deadline expired around October 24, 2025, but the report remained undisclosed, the plea says. It relies on a reply under the Right to Information Act from the First Appellate Authority of CDSCO, which confirmed that the sub-committee's report was still awaited and that the matter continued to remain under review. The court has now asked the four authorities to respond to the petition; it has not itself ruled on whether Ranitidine is safe or unsafe.

Source: Nation Press