India May Ban Popular Antacid Ranitidine After Years Of Deliberation On Cancer Risks, Expert Panel Files Report
After years of deliberation, India is likely to ban the widely used over-the-counter (OTC) antacid Ranitidine due to cancer-causing concerns, News18 has learnt.
The ban has been recommended by an expert panel, and its report has been submitted to the apex body, Drug Technical Advisory Board (DTAB), which advises the Drug Controller General of India on regulatory actions.
According to the latest agenda document for the meeting of the Drug Technical Advisory Board, seen by News18, DTAB is slated to discuss this report recommending the 'suspension of the drug ranitidine for manufacture, sale and distribution in the country".
Among several observations, the report noted that of the 42 Ranitidine samples tested at the Central Drug Laboratory in Kolkata, 21 were found to contain NDMA impurities exceeding 0.32 PPM. This level surpasses the globally acceptable limit for the impurity, which is linked to an increased risk of cancer over a lifetime.
The drug Ranitidine reduces the amount of acid made in the stomach, and it relieves acid-related indigestion and heartburn. It is sold under popular brand names such as Aciloc, Rantac, and Zinetac. However, this category of medicines has been under scrutiny since 2019, when the US Food and Drug Administration alerted about a drug that contains low levels of cancer-causing substances.
The US FDA had suggested that some Ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. 'NDMA is classified as a probable human carcinogen—a substance that could cause cancer—based on results from laboratory tests," the FDA had said earlier.
India had been deliberating over the use of this category of drugs since then. Meanwhile, in 2022, the central government dropped the drug from the national list of essential medicines (NLEM) due to cancer-causing concerns.
What does the latest report say?
The agenda document, seen by News18, lists 'Consideration of the proposal to examine the safety related to Ranitidine drug due to the presence of NDMA impurity".
It said that the 'safety issue related to the Ranitidine drug due to the presence of NDMA impurity has been under consideration for quite some time, and CDSCO has taken various measures from time to time".
It recalls that 'Ranitidine was in the National List of Essential Medicines (NLEM), 2015. However, it was deleted and does not appear in NLEM, 2022".
To have a broad-based decision in the matter, an expert committee was constituted in 2024. Now, the subcommittee has submitted its report for further deliberation at the DTAB meeting.
'After detailed deliberation, the committee recommended for suspension of the drug Ranitidine for manufacture, sale and distribution in the country," said the document while attaching the report submitted by the panel.
However, the subcommittee and DTAB can only deliberate on the issue and submit their recommendation on the matter to the apex authority, the Drug Controller General of India (DCGI). The final move kicks in only when DCGI approves DTAB's recommendations.
Report submitted by panel to DTAB
The panel—led by Dr Vineet Ahuja, Department of Gastroenterology at All India Institute of Medical Sciences (AIIMS), New Delhi—noted that 'international regulatory agencies and available literature mention that ranitidine may contain a nitrosamine impurity called NDMA at low levels".
From the presentation delivered by the members of the committee, the panel found that 'NDMA and NDEA belong to the 'cohort of concern', which is a group of highly potent mutagenic carcinogens that have been classified by the WHO's International Agency for Research on Cancer as probably human carcinogens".
'Various studies conducted revealed that the presence of NDMA may result from a slow degradation of the ranitidine molecule through the intermolecular reaction of ranitidine hydrochloride without the involvement of impurities," it said.
The report also noted that 'Ranitidine hydrochloride and its inherent Impurities A, C, D, E, H, and NDMA at different rates in ranitidine".
The subcommittee observed that the internationally acceptable intake limit of NDMA is 96 ng per day or 0.32 ppm of NDMA in the active ingredient. However, 'Total 42 samples of Ranitidine API were tested in CDL, Kolkata, out of which 21 samples were found to have NDMA impurity more than 0.32 PPM (ranged from 0.336 PPM – 5.19 PPM)."
'The acceptable intake (AI) limit for nitrosamines in drugs is generally set to correspond to an increased cancer risk of one additional case in 100,000 subjects over a lifetime of 70 years," the report said.
The subcommittee has reviewed the decisions of different stringent regulatory authorities on the drug Ranitidine, including the US, Japan, Europe, Australia, and Canada, among others. 'The committee concluded that the drug Ranitidine is withdrawn/suspended by regulatory agencies such as USFDA, EMA, TGA and is no longer being distributed in the USA, EU, Australia and Japan," said the report.
The panel also observed that other standard-of-care drugs to treat heartburn by reducing stomach acid and preventing gastric reflux and ulcers are already available in the country.
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'…after evaluating the global regulatory status of the drug ranitidine and observation that global regulatory authorities have discontinued the drug ranitidine due to concerns over NDMA contamination and as the chemical structure of ranitidine predisposes the risk of nitrosamine impurity and as some of the samples tested were within NDMA acceptable level whereas some sample were out of the limit," said the report.
The panel, as a precautionary measure, recommends 'suspension of drug Ranitidine for manufacture, sale and distribution in the country. However, the committee opined that people taking ranitidine should consult their healthcare professional for other treatment options".
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drug medicine
Location :
New Delhi, India, India
First Published:
April 22, 2025, 19:15 IST
News india India May Ban Popular Antacid Ranitidine After Years Of Deliberation On Cancer Risks, Expert Panel Files Report
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