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.
top videos
View all
'…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".
tags :
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
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
News18
9 hours ago
- News18
'Paramedical' Term Dropped: Govt Mandates Use Of 'Allied And Healthcare' Across India
The order by NCAHP states that the move has been taken to ensure uniformity in terminology and alignment with the National Commission for Allied and Healthcare Professions Act. The central government has formally directed all states, union territories, and relevant educational institutions to discontinue the use of the term 'Paramedical" and instead adopt 'Allied and Healthcare" in all official communications, policies, advertisements, and academic references, News18 has learnt. The move comes in line with the provisions of the National Commission for Allied and Healthcare Professions (NCAHP) Act, 2021, which was enacted to standardise and regulate this wide-ranging group of health professionals under a unified framework. In fact, the order, dated July 1, has been issued by the National Commission for Allied and Healthcare Profession (NCAHP) under the Ministry of Health and Family Welfare. 'The term 'Paramedical' has long been used to describe various healthcare-related professions that provide support services in healthcare delivery. However, with the enactment of the NCAHP Act, 2021, the term 'Allied and Healthcare' has been formally adopted," said the circular seen by News18. 'In this regard, the use of the term 'Paramedical' is advised to be avoided and replaced with 'Allied and Healthcare' in all training programmes, recruitment notifications, advertisements, educational materials, and all forms of communication – both verbal and written," the circular said. Sent to chief secretaries, principal secretaries and health secretaries of all states and union territories, the order states that the move has been taken to ensure uniformity in terminology and alignment with the Act. The commission has recommended immediate compliance by all state governments, UT administrations, and institutions. This includes changing terminology in training programmes, recruitment notifications, educational materials, advertisements, and all forms of communication — both verbal and written. 'Therefore, all state governments/UT administrations and institutions are requested to ensure compliance with this nomenclature change and disseminate the information to all concerned authorities, institutions, and stakeholders under their jurisdiction," the order said. New term not ambiguous, aligns with global nomenclature 'If you go by the exact meaning of paramedical, traditionally it is used to describe roles that support doctors such as lab technicians but it's not a legally defined category and can be ambiguous," a senior government official, who was part of the meetings and discussions to change the nomenclature explained while requesting anonymity. 'When we say allied it means a group of professionals who are 'associated alongside" medicine covering disciplines like physiotherapy, radiography, occupational therapy, etc" he said while adding that 'Putting 'Allied and Healthcare' together creates a clearly defined, legally backed umbrella for all non-medical-doctor roles in the health sector. Meanwhile, health departments of all states and UTs have been directed to disseminate this instruction to all concerned authorities, institutions, and stakeholders under their jurisdiction without delay. The change marks, according to the government official quoted above, a 'significant administrative and educational shift, particularly for thousands of students enrolled in what have traditionally been referred to as paramedical courses, as well as for faculty, health institutions, and public communication channels" who will now be known by a better-recognised, standardised nomenclature under the 'Allied and Healthcare" category. 'This shift aligns them with global terminology, potentially improving career mobility and academic parity."
&w=3840&q=100)
First Post
a day ago
- First Post
23 deaths due to heart attack in 40 days in Karnataka's Hassan: Is there a ‘Covid vaccine' link?
In just 40 days, Karnataka's Hassan district has reported 23 heart attack deaths, many involving young or middle-aged people. Chief Minister Siddaramaiah has questioned whether there could be a link between these deaths and the Covid vaccine. The Union Health Ministry, however, has said that there is no evidence to suggest that the vaccine is causing sudden deaths among adults read more This rise in cases has also led to an 8 per cent increase in patients visiting Jayadeva Hospital in Bengaluru. News18 Heart attack-related deaths have gone up alarmingly in Karnataka's Hassan district. In the past 40 days, 23 people have died after suffering heart attacks. Karnataka Chief Minister Siddaramaiah has now set up a team of experts, led by Dr Ravindranath from the Jayadeva Institute, to find out what is behind the spike. The panel has been asked to give its report in 10 days. ALSO READ | Shefali Jariwala death: What are glutathione injections, and are they safe? STORY CONTINUES BELOW THIS AD The Chief Minister has also questioned whether the Covid vaccine might have anything to do with these deaths. So, what's really going on in Hassan? Is there a link between the vaccine and the deaths, as the state government claims? Let's take a look: What happened? In just 40 days, Karnataka's Hassan district has reported 23 deaths, all caused by heart attacks. Another troubling concern is that many of those who died were either young or middle-aged. Data from May 28 to June 29, 2025, indicates a concerning view across age groups. Karnataka CM Siddaramaiah links Covid vaccines with surge in heart attack-related deaths in Hassan, triggers political row News18's @harishupadhya and @Elizasherine with details "Vaccines have been safe, they are not associated with cardiac diseases": Dr Sanjeev Bagai… — News18 (@CNNnews18) July 2, 2025 The list includes four people under the age of 20 (two boys and two girls), one woman aged between 21 and 29, five men between 30 and 40, seven men aged 41 to 59, and one man over 60. On Tuesday, a 27-year-old woodworker was the latest to die after suffering a heart attack. STORY CONTINUES BELOW THIS AD This rise in cases has also led to an 8 per cent increase in patients visiting Jayadeva Hospital in Bengaluru over the past two weeks, mostly from Hassan and nearby areas. Figures from the District Health and Family Welfare Department show that Hassan has seen 507 heart attack cases in the last two years, with 190 resulting in death, India Today reported. Another troubling concern is that many of those who died were either young or middle-aged. Pixabay/Representational Image What did the state government say? A high-level meeting was held on June 30 at the office of the Hassan District Collector. It was chaired by the Principal Secretary of the Health and Family Welfare Department and attended by key medical experts, including the Director of the Sri Jayadeva Institute of Cardiovascular Sciences, the District Health and Family Welfare Officer, District Surgeon, Medical Superintendent, and the District Surveillance Officer. An expert committee led by Dr Ravindranath has also been set up to find out what is behind the deaths and submit a report. In the past month alone, in just one district of Hassan, more than twenty people have died due to heart attacks. The government is taking this matter very seriously. To identify the exact cause of these series of deaths and to find solutions, a committee of experts has been… — Siddaramaiah (@siddaramaiah) July 1, 2025 STORY CONTINUES BELOW THIS AD Chief Minister Siddaramaiah, meanwhile, has raised doubts about whether there could be a link between these deaths and the Covid vaccine, adding that the vaccine may have been approved and rolled out too quickly. He wrote on X, 'Orders were given to this same committee back in February to conduct a thorough study on the reasons behind sudden deaths among young people in the state, and whether the Covid vaccines could have any adverse effects.' 'It cannot be denied that the hasty approval and distribution of the Covid vaccine to the public could also be a reason for these deaths, as several studies worldwide have recently indicated that Covid vaccines could be a cause for the increasing number of heart attacks,' he added. STORY CONTINUES BELOW THIS AD ALSO READ | Killer dreams: How nightmares can lead to early death Karnataka Health Minister Dinesh Gundu Rao told News18 that he has asked the expert team to visit the area, look into the deaths, and check if similar incidents are being reported in other parts of the state. He also urged people not to panic and said the health department was treating the matter seriously. 'Once we get the report, we will be able to speak with greater clarity. These are matters that must be properly investigated. Speculation at this stage could cause unnecessary alarm,' he said. The Chief Minister has also questioned whether the Covid vaccine might have anything to do with these deaths. Pixabay/Representational Image On Tuesday, the Union Health Ministry said there is no evidence to suggest that Covid vaccines are causing sudden deaths among adults. Citing studies by the Indian Council of Medical Research (ICMR) and the National Centre for Disease Control (NCDC), the ministry said the issue had been looked into by multiple agencies. 'The matter of sudden unexplained deaths has been investigated through several agencies in the country. These studies have conclusively established that there is no direct link between Covid 19 vaccination and the reports of sudden deaths in the country," it said in a statement. STORY CONTINUES BELOW THIS AD #HealthForAll Extensive studies by @ICMRDELHI and AIIMS on sudden deaths among adults post COVID have conclusively established no linkage between COVID-19 vaccines and sudden deaths Lifestyle and Pre-Existing Conditions identified as key factorshttps:// — Ministry of Health (@MoHFW_INDIA) July 2, 2025 The government added that sudden cardiac deaths could be caused by many factors, such as genetics, lifestyle choices, underlying health problems, and even post-Covid complications. 'Studies by the Indian Council of Medical Research (ICMR) and National Centre for Disease Control (NCDC) affirm that Covid-19 vaccines in India are safe and effective, with extremely rare instances of serious side effects. Sudden cardiac deaths can result from a wide range of factors, including genetics, lifestyle, pre-existing conditions, and post-Covid complications," the press release said. STORY CONTINUES BELOW THIS AD The spike in heart-related deaths has left doctors and health experts worried across different age groups. Did the Covid vaccine play a role in the recent heart attack deaths? The expert panel's findings are expected to give some answers soon.
News18
2 days ago
- News18
'Not Just Hassan': Area MP Shreyas Patel To News18 On Spike In Heart Attack Deaths Of Youths
Asked why Hassan is in the spotlight, he said it's because every cardiac-related death is being tracked, documented, and responded to seriously It's not just Hassan, but several districts in Karnataka and across India are seeing a rise in young people dying of heart attacks, said Hassan MP Shreyas Patel in an exclusive interview with News18. Asked why Hassan is in the spotlight, he said it's because every cardiac-related death is being tracked, documented, and responded to seriously. 'We are keeping a close watch on heart attack cases, especially among the 18-40 age group, which is why the numbers look high. It's not only happening here, but we are logging every heart-related issue or death and monitoring it closely," he said. The spike in heart attack-related deaths in Hassan prompted the Siddaramaiah government, the local district administration, and the health department under minister Dinesh Gundu Rao to launch a probe into the matter. Karnataka health commissioner Randeep D also sought a report on the Hassan cardiac deaths, calling them concerning. Chief minister Siddaramaiah said on Monday that the government would identify and resolve the underlying problem, adding that directions have been given to the health department to form a committee. According to MP Patel, Hassan's medical institutions immediately launched a coordinated response. 'Over the past month, we've been tracking every case. On June 17, we had a detailed meeting with the district health officer, the director of HIMS, cardiologists from HIMS and private hospitals. We took stock of the situation and began taking action immediately," said the MP. Training has also been prioritised. 'We've directed all assistant medical officers that any patient suspected of having a heart attack must be treated without delay. Not just doctors—every healthcare worker, including staff nurses and support staff, must know what to do as immediate first aid. We've already begun batch-wise training for all medical staff since June 17," he confirmed. The district has also begun implementing the STEMI system—a real-time video consultation setup operated directly by a team of cardiologists from Jayadeva Hospital. Patel said the system has already been installed in three to four hospitals and that they have requested the health minister to extend it to all CHCs. 'He has agreed in principle, and we hope to get approval soon," the MP said. But beyond infrastructure, he insisted that awareness is key. 'People should cooperate with us. They should regularly undergo checkups—echocardiograms, TMT, and ECG. All of these are free and available at Hassan District Hospital. The public must take advantage of this." When asked why heart attack cases are being reported so extensively from Hassan alone, Patel was quick to clarify: 'No, it's not just Hassan. We are simply maintaining daily accounts—how many deaths have occurred due to heart attacks and how many people have been admitted. Those figures are being put out in the media. That's why it looks like it's concentrated here. But this is an issue for all districts. What's different is how seriously we've taken it." He said the focus now is on preventing deaths among young people. 'The main aim is to protect lives in the 18 to 35 age group. We don't want any more young lives lost to sudden cardiac issues," he said. Patel confirmed that cases in Hassan are being clearly marked as heart attacks, not just broadly listed under 'unnatural deaths", which is the usual classification in many other districts. 'We've been observing the trend carefully for a month. Every heart-related admission or death is recorded. That's the data we've provided to the media," he said. He added that health minister Dinesh Gundu Rao has directed the director of the Jayadeva Institute to submit a detailed report on the Hassan deaths within ten days. 'Once that report is in, we will act based on science and evidence, not panic. But this issue is real, and we're treating it with the urgency it demands," Patel said. First Published:
