Latest news with #Ranitidine
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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:
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Business Standard
23-04-2025
- Health
- Business Standard
Is your heartburn pill safe? Panel recommends banning ranitidine in India
The government may consider a nationwide ban on the widely used antacid ranitidine after an expert committee reportedly submitted a detailed report highlighting its potential cancer risks. According to a report by News18, which claims to have accessed the confidential document, the expert panel's findings may finally lead to regulatory action on a drug that has been under scrutiny since 2019. Panel recommends ranitidine suspension over NDMA cancer risk The report by the expert panel has been submitted to the apex body, the Drug Technical Advisory Board (DTAB), which advises the Drug Controller General of India on regulatory actions. According to the latest agenda document for the DTAB meeting, accessed by News18, the board is set to deliberate on a recommendation to suspend the manufacture, sale, and distribution of ranitidine in India. Half of ranitidine samples exceed global NDMA safety limits The report noted that, of the 42 samples of ranitidine tested at the Central Drug Laboratory in Kolkata, 21 were found to contain levels of N-nitrosodimethylamine (NDMA) impurities exceeding 0.32 parts per million. This surpasses the globally accepted threshold for the impurity, which is associated with a heightened risk of cancer upon prolonged exposure. What is ranitidine, and why was it so widely used? Ranitidine, first developed in 1981 in Europe by Glaxo Holdings Ltd, now part of GlaxoSmithKline (GSK) PLC, is sold over the counter under popular brand names such as Rantac, Zinetac, and Aciloc. It works by reducing stomach acid and is commonly used to relieve indigestion, heartburn, and treat gastroesophageal reflux disease (GERD) and ulcers of the stomach and intestines. Though banned in the United States, Europe, Australia, and several other countries, it has been a staple in Indian households for decades. Concerns over the drug arose after several international regulatory bodies—including the US Food and Drug Administration, European Medicines Agency, and Australia's Therapeutic Goods Administration—removed ranitidine from their markets over unacceptable levels of NDMA. In December 2024, the government informed the Rajya Sabha that the Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory body, had taken steps to address safety concerns surrounding NDMA in ranitidine. Ranitidine removed from essential medicines list in 2022 While India has thus far refrained from banning ranitidine, it was removed from the National List of Essential Medicines (NLEM) in 2022, and multiple safety advisories were issued. The News18 report now suggests that a formal ban may soon follow.
