Delhi HC issues notice on plea seeking time-bound safety review of acidity drug Ranitidine
New Delhi, Nov 4 (IANS/WISHAVWARTA) 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.
Issuing a notice, 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) on the petition.
The petition, filed by Dr Chandresh Jain, a qualified doctor and practicing advocate, seeks directions to the authorities to complete the pending regulatory review and publish a reasoned conclusion within a fixed timeframe.
The plea does not seek an outright ban on Ranitidine or a judicial determination of its scientific safety but contends that the Union government’s own regulatory review has remained inconclusive despite multiple expert committee recommendations and the expiry of a stipulated reporting deadline.
Ranitidine, marketed in India for over three decades under brands such as Aciloc, Rantac, R Loc, Ranitin and Zinetac, came under international scrutiny in September 2019 following concerns over the presence or formation of nitrosodimethylamine (NDMA), 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, while the European Medicines Agency recommended precautionary suspension of the medicines in the European Union.
However, the petition clarified that regulatory actions taken in other countries do not, by themselves, determine the safety of products currently being sold in India and that the country’s own regulatory assessment remains without a disclosed final decision.
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 constituting 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 Office Memorandum issued on July 24, 2025, the Drugs Controller General of India (DCGI) constituted a 16-member Sub-Committee and prescribed a three-month deadline for submission of its report.
The plea said the deadline expired around October 24, 2025, but the report remained undisclosed. The plea further relied on a RTI reply, furnished by 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 petitioner has contended that the prolonged pendency of the regulatory exercise warrants judicial intervention to ensure that the authorities reach and disclose a reasoned conclusion within a reasonable period.
The plea clarified that the High Court was not being asked to substitute its judgment for that of scientific and regulatory experts or to direct a prohibition on the drug’s manufacture, distribution and sale.
Instead, it sought a direction to the authorities to bring the review process, which has continued through successive expert committees, to a time-bound conclusion in the larger public interest.
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