The Delhi High Court on Wednesday, 4 November 2026 issued notice on a Public Interest Litigation (PIL) demanding a time-bound and reasoned decision from the Centre on the safety of Ranitidine, a widely prescribed acidity medication sold in India for over three decades, amid unresolved concerns about the possible presence of a cancer-linked impurity in the drug.

What the Court Has Directed

A Division Bench comprising Acting Chief Justice Nitin Wasudeo Sambre and Justice Sanjay Sharma issued notices to 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), seeking their responses to the petition. The PIL was filed by Dr Chandresh Jain, described as a qualified doctor and practising advocate.

Notably, the petition does not seek an outright ban on Ranitidine or ask the court to rule on its scientific safety. Instead, it asks that the government's own regulatory review — which has passed through successive expert committees without a publicly disclosed conclusion — be brought to a time-bound end.

The NDMA Concern and Global Context

Ranitidine came under international scrutiny in September 2019 after regulators flagged the possible presence or in-situ formation of nitrosodimethylamine (NDMA), a compound classified by the International Agency for Research on Cancer (IARC) as a probable human carcinogen. In April 2020, the US Food and Drug Administration (FDA) requested manufacturers to withdraw all prescription and over-the-counter Ranitidine products. The European Medicines Agency similarly recommended a precautionary suspension across the European Union.

The PIL, however, clarified that regulatory actions in other jurisdictions do not automatically determine the status of products sold in India, and that an independent domestic assessment is both necessary and overdue.

India's Stalled Regulatory Process

The petition traced a detailed timeline of India's own regulatory proceedings. The 92nd meeting of the DTAB, held on 24 April 2025, recommended constituting a larger expert committee, commissioning an ICMR safety study, monitoring NDMA levels in circulating stocks, and considering risk-based measures including a possible reduction in the drug's shelf life.

Acting on that recommendation, the Drugs Controller General of India (DCGI) issued an Office Memorandum on 24 July 2025, constituting a 16-member Sub-Committee with a three-month deadline to submit its report — a deadline that reportedly expired around 24 October 2025.

The petitioner relied on a reply obtained under the Right to Information (RTI) Act from the First Appellate Authority of CDSCO, which confirmed that the Sub-Committee's report was still awaited and that the matter remained under active review. Ranitidine is currently marketed in India under brands including Aciloc, Rantac, R Loc, Ranitin, and Zinetac.

What the Petition Asks For

The PIL contends that the prolonged pendency of the regulatory exercise — spanning multiple expert panels and a missed reporting deadline — warrants judicial oversight to ensure a disclosed, reasoned conclusion is reached within a reasonable timeframe. The petitioner has explicitly stated that the High Court is not being invited to substitute its judgment for that of scientific experts or to direct a prohibition on the drug's manufacture, distribution, or sale.

What Happens Next

With notices now issued, the Ministry of Health, CDSCO, DTAB, and ICMR are expected to file their responses before the bench. The court's intervention could accelerate a regulatory process that has remained inconclusive for over five years since global safety concerns first surfaced. How the government responds — and how quickly — will determine whether millions of Indians who use Ranitidine-based products receive a clear, evidence-backed safety verdict.