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Business Standard
01-05-2025
- Health
- Business Standard
Ban on popular heartburn drug Ranitidine deferred amid cancer concerns
If you've ever reached for a tablet after a spicy meal, chances are it was Ranitidine—commonly sold under brand names like Zinetac, Rantac, or Aciloc. For years, it has been the go-to remedy for acid reflux and heartburn. But lately, the drug has been in the news for all the wrong reasons. Some studies have found that Ranitidine can contain N-nitrosodimethylamine (NDMA), a chemical possibly linked to cancer. Despite global apprehension regarding the potential carcinogenic impurity, Indian authorities have opted not to ban the widely used heartburn medication. Countries are banning Ranitidine. Why not India? Ranitidine has been under scrutiny since 2019, when studies indicated that it could degrade over time to form NDMA, a probable human carcinogen. This led to its withdrawal in several countries, including the United States, European Union, and Australia. Recently in India, an expert panel recommended the drug's suspension, but the Drug Advisory Committee decided instead to form a larger committee to evaluate all aspects. Following a meeting last week, the Drugs Technical Advisory Board (DTAB) also advised the Indian Council of Medical Research (ICMR) to conduct a study to assess Ranitidine's safety, The Economic Times reported. What is Ranitidine, and why was it so widely used? Developed in 1981 by Glaxo Holdings Ltd (now part of GlaxoSmithKline or GSK PLC), Ranitidine became one of the most widely used medications for managing stomach acid. Marketed under popular brands like Rantac, Zinetac, and Aciloc, it was readily available over the counter. The drug was widely used to relieve indigestion and heartburn, and to treat conditions such as gastroesophageal reflux disease (GERD) and ulcers. Despite being banned in several countries, Ranitidine remained a staple in Indian households for decades. Half of Ranitidine samples exceed global NDMA safety limits The Central Drugs Standard Control Organisation (CDSCO) has taken measures to ensure patient safety. Last year, it formed a committee to examine NDMA-related safety concerns. Ranitidine samples were sent to a government lab for analysis, and the results raised concern. Out of 42 samples tested at the Central Drug Laboratory in Kolkata, 21 were found to have NDMA levels above 0.32 parts per million (ppm)—exceeding the internationally accepted safety limit. Long-term exposure to such levels has been linked to increased cancer risk. The controversy has sparked significant legal action globally. In the US, pharmaceutical companies such as GSK have faced numerous lawsuits alleging that Ranitidine caused cancer. So, should you still be taking it? Here's the honest answer: Talk to your doctor. If you're using Ranitidine occasionally and haven't experienced any issues, your doctor may still consider it acceptable. But if you're concerned, there are other alternatives that do not carry the same risk. For now, Ranitidine remains legally available in India, though regulators are keeping it under close observation.
Economic Times
30-04-2025
- Health
- Economic Times
Ranitidine ban deferred despite cancer concerns
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel New Delhi: Despite concerns over presence of cancer causing agents in popular antacid Ranitidine and a recent recommendation by an expert panel for suspension of the drug, India's top drug advisory body has decided to ignore and form another "larger committee" to look into all aspects of the is widely sold in India under brand names like Aciloc, Rantac and a meeting held last week, the Drugs Technical Advisory Body (DTAB) also recommended that the Indian Council of Medical Research (ICMR) should conduct a study to assess the safety of the drug. The drug was withdrawn/suspended by regulatory bodies including the USFDA, European Medicines Agency (EMA), and Australia among others,Last year a committee was constituted to examine the safety issue of Ranitidine in the light of the nitrosodimethylamine (NDMA) experts got samples of Ranitidine tested at a government run laboratory. 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 evaluating the global regulatory status of the drug and having found some of the samples in India exceeding the safety limit, the expert committee recommended for the "suspension of the drug Ranitidine for manufacture, sale and distribution in the country," it said. The committee also recommended that the people taking Ranitidine should consult their health care professional for other treatment options.
Time of India
30-04-2025
- Health
- Time of India
Ranitidine ban deferred despite cancer concerns
New Delhi: Despite concerns over presence of cancer causing agents in popular antacid Ranitidine and a recent recommendation by an expert panel for suspension of the drug, India's top drug advisory body has decided to ignore and form another "larger committee" to look into all aspects of the drug. #Pahalgam Terrorist Attack A Chinese shadow falls on Pahalgam terror attack case probe How India can use water to pressure Pakistan Buzzkill: How India can dissolve the Pakistan problem, not just swat it It is widely sold in India under brand names like Aciloc, Rantac and Zinetac. After a meeting held last week, the Drugs Technical Advisory Body (DTAB) also recommended that the Indian Council of Medical Research (ICMR) should conduct a study to assess the safety of the drug. The drug was withdrawn/suspended by regulatory bodies including the USFDA, European Medicines Agency (EMA), and Australia among others, Last year a committee was constituted to examine the safety issue of Ranitidine in the light of the nitrosodimethylamine (NDMA) impurity. The experts got samples of Ranitidine tested at a government run laboratory. 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. After evaluating the global regulatory status of the drug and having found some of the samples in India exceeding the safety limit, the expert committee recommended for the "suspension of the drug Ranitidine for manufacture, sale and distribution in the country," it said. The committee also recommended that the people taking Ranitidine should consult their health care professional for other treatment options.
News18
29-04-2025
- Health
- News18
Expert Panel Suggests Deeper Review Of Antacid Ranitidine, ICMR May Assess Cancer Risk
Last Updated: The widely used antacid is sold under popular brand names like Aciloc, Rantac, and Zinetac The Indian Council of Medical Research (ICMR) may now conduct a study to assess the safety of the popular antacid, Ranitidine, News18 has learnt. Facing controversy due to cancer-causing concerns, the drug Ranitidine works by reducing 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. The drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO), may also ask manufacturers of the drug to closely monitor certain parameters in the medicine and implement risk-based measures, such as reducing shelf life, to mitigate potential risks. On April 22, News18 reported that the apex panel of experts, the Drugs Technical Advisory Board (DTAB), is slated to discuss a report recommending the 'suspension of the drug ranitidine for manufacture, sale and distribution in the country". However, the panel has now recommended the formation of a larger expert committee to comprehensively examine concerns related to the widely used antacid drug. After detailed deliberation, the apex board concluded that all aspects of the drug, including its storage conditions, need to be re-evaluated, especially in light of the presence of NDMA (N-Nitrosodimethylamine) impurity, which is a probable human carcinogen. 'After detailed deliberation, the board recommended that a larger committee is required to be constituted, which will look into all aspects, including the storage conditions of the ranitidine drug," according to the DTAB's minutes of the meeting, seen by News18. 'DTAB, further, recommended that ICMR may conduct a study for assessing the safety of the Ranitidine drug considering the presence of NDMA impurity." Further, the panel opined that 'manufacturers should monitor the NDMA levels in the API/formulation and also take risk-based measures such as reducing the shelf life, etc". According to a senior official who is part of the expert panel, the majority of Indian houses have been consuming Ranitidine for decades now without facing any significant concerns. 'Do they all have cancer?" he asked while adding, 'We need to find out under what circumstances the drug becomes carcinogenic… We need to understand that now we have a new line of antacid molecules as well. We, as a panel of experts, won't wonder if there is any other lobby which is trying to push their new molecules over the already settled ones, like Ranitidine. Hence, we need to take a balanced and data-based approach before discarding the otherwise proven antacid." Ranitidine has been under scrutiny since 2019, when the American health watchdog, the US Food and Drug Administration, alerted and said the drug contains low levels of cancer-causing substances. The US agency 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. In 2022, the central government dropped the drug from the national list of essential medicines (NLEM) due to cancer-causing concerns. First Published:
News18
22-04-2025
- Health
- News18
India May Ban Popular Antacid Ranitidine After Years Of Deliberation On Cancer Risks, Expert Panel Files Report
Ranitidine reduces the amount of acid in the stomach and relieves acid-related indigestion and heartburn. It is sold under popular brand names like Aciloc, Rantac and Zinetac 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
