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

The Delhi High Court is seeking accountability for an unfinished safety review of Ranitidine. It issued notice to the Centre, CDSCO, DTAB and ICMR, asking for their responses to a petition seeking completion of the review within a stipulated period. The issue matters because Ranitidine is cheap, widely available and often bought without prescription.

The petition was filed by Dr Chandresh Jain. It says the safety question began in September 2019, after foreign regulators were alerted to NDMA in Ranitidine products. On April 24, 2025, DTAB referred the matter to another committee and an ICMR study. The Union government set a three-month reporting deadline on July 24, 2025.

That deadline passed around October 24, 2025. Yet CDSCO said on October 7, 2026, that the report was still awaited. The matter will next be heard in February, while the court considers the regulators’ responses and the request for a time-bound decision.

Ranitidine is a medicine commonly used to treat acidity and reduce the amount of acid in the stomach. Lowering stomach acid can relieve the burning discomfort associated with acidity and help manage related symptoms. The article focuses on Ranitidine because it remains widely available and is often bought without a prescription.

As a drug, Ranitidine works by blocking histamine signals that tell certain stomach cells to release acid. This reduces acid production rather than simply neutralising acid already present. That mechanism explains its use for acidity, although the article itself only identifies its general purpose and does not discuss the pharmacology in detail.

The medicine’s low price and easy availability are central to the legal concern. The petition says people who depend on it may have fewer resources to find or pay for alternatives. Because regulators have not issued a final, publicly available decision, patients and healthcare providers face continuing uncertainty about its safety status in India.

NDMA stands for N-nitrosodimethylamine. It is classified as a probable human carcinogen, meaning it is considered capable of causing cancer in people based on available evidence. The article says foreign drug regulators were alerted in September 2019 to NDMA’s presence in products containing Ranitidine.

The safety concern is about contamination, not Ranitidine’s intended use for acidity. If a medicine contains a potentially harmful substance, regulators must assess how much may be present, whether levels change during storage, and whether patients could face meaningful risk. NDMA can damage genetic material, which is why exposure is treated as a serious concern. These mechanisms are general scientific context beyond the article’s specific details.

The petition says several regulators took action in 2020, but India’s regulator had not published a final, reasoned decision. Until the review is completed, the public lacks a clear regulatory conclusion about whether Ranitidine products should continue, face restrictions, or be removed.

The safety question began in September 2019, when foreign drug regulators were alerted to NDMA in products containing Ranitidine. By October 2026, that meant the issue had remained unresolved for more than seven years. The petition argues that India’s drug regulator still had not disclosed a final, reasoned or publicly available decision.

The latest formal deadline arose after DTAB referred the matter to another committee and an ICMR study on April 24, 2025. The Union government fixed a three-month deadline for the report on July 24, 2025. That period ended around October 24, 2025. The key issue was not merely the passage of time, but the absence of a completed public safety conclusion.

On October 7, 2026, CDSCO reportedly maintained that the report was awaited and the matter remained under review. The Delhi High Court has now sought responses from the Centre and relevant bodies. The case is next listed for February.

The petition identifies six major countries or regions that reached some regulatory decision on Ranitidine after the 2019 alerts. They were the United States, the European Union, Australia, Canada, the United Kingdom and Singapore. Counting the United States as one and each named region or country separately gives six.

The article gives a specific comparison for the United States, European Union and Australia. It says each took regulatory action in 2020, although their legal frameworks differed. The petition also states that Canada, the United Kingdom and Singapore reached some decision after the alerts. It does not describe every decision’s precise content.

India’s situation is presented as different because its review was still pending. The petition alleges that, despite examining the issue for several years, India’s drug regulator had not published a final, reasoned decision. The Delhi High Court has sought responses as it considers whether the process should be completed within a stipulated timeframe.

When a possible cancer-causing contaminant is suspected but regulators do not issue a final decision, patients may be left unsure whether to continue treatment, seek alternatives or ask for medical advice. The article does not establish that Ranitidine has caused cancer. It highlights the uncertainty created when the safety question remains unresolved.

A cheap, widely available medicine is especially important in this situation. The petition says Ranitidine is often bought without a prescription. That can make continued use more likely while the review remains pending. People with limited money or access to healthcare may have fewer practical choices, particularly if other medicines cost more or require professional advice.

A final regulatory decision could clarify whether products should continue, be restricted, recalled or otherwise managed. Until then, patients and providers lack a clear public conclusion from Indian authorities. The Delhi High Court’s notice may push the Centre and regulators to explain the delay and complete the review.

A drug regulator begins by collecting evidence about the suspected problem. It may review laboratory findings, inspect manufacturing records, test samples and examine how much of the substance patients could receive. It also considers the medicine’s benefits, available alternatives and the seriousness of the possible harm. These are general regulatory steps; the article does not describe India’s full investigation process.

Expert bodies can then analyse the evidence and recommend action. In this case, the article says DTAB referred Ranitidine to another committee and an ICMR study. Regulators may decide to continue a medicine if risks are acceptable, restrict its use, require warnings, recall affected batches or ban it when the risk outweighs the benefits. The exact choice depends on the evidence and legal framework.

A sound process should produce a reasoned, publicly available decision. The petition alleges India had not published one, even after years of review. The High Court has sought responses from the Centre, CDSCO, DTAB and ICMR, potentially moving the issue toward a clearer and time-bound conclusion.