Expert Panel Suggests Deeper Review Of Antacid Ranitidine, ICMR May Assess Cancer Risk
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:
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
News18
2 days ago
- News18
No Link Between Covid Vaccine & Sudden Cardiac Deaths: Karnataka Govt Research Amid Hassan Surge
Dr KS Ravindranath, Director, Sri Jayadeva Institute of Cardiovascular Sciences and Research, said, 'We haven't seen a direct link between vaccine or COVID and heart attacks." Amid the surge in heart attack fatalities in Hassan district, a research commissioned by the Karnataka government prior to the incident has found no causal link between Covid-19 vaccines and sudden cardiac deaths. The report has attributed the rise to an increase in conventional risk factors such as hypertension, obesity, and diabetes. Speaking to CNN-News18, Dr KS Ravindranath, Director of the Sri Jayadeva Institute of Cardiovascular Sciences and Research, said, 'We haven't seen a direct link between vaccine or COVID and heart attacks." 'Risk factors have gone up post Covid' Dr Ravindranath highlighted that their observational pilot study at Jayadeva Hospital, examining over 200 patients under 45 in April and May, did not find an association between premature cardiovascular disease and a prior history of COVID-19 infection or vaccination. But he highlighted that the risk factors had gone up significantly post COVID. 'Post-Covid, we have seen a 6-8% increase in other risk factors such as hypertension, obesity, diabetes, etc.," Dr Ravindranath noted, emphasising the shift in risk profiles. He further clarified that these increases are also observed in younger demographics (20-30 year olds), attributing it to stress, lifestyle changes, and potential hormonal shifts post-Covid, alongside job losses. 'Hassan incident in line with broader trend' Regarding the ongoing probe into deaths in Hassan district, Dr Ravindranath clarified that it's not an isolated epidemic, but rather in line with broader trends. 'What we have seen is that most of the private hospitals there, if you look at most of the people admitted there due to heart attacks, 200 plus," he explained. 'Any heart attack has a 5-6% mortality rate, up to 8% sometimes, in that range, mortality is known. So when the numbers are more, obviously the deaths are severe." He added that India's incidence of heart attacks has generally risen compared to Western countries, occurring about 10 years earlier on average. The report's recommendations include establishing a cardiac surveillance program, a national registry for sudden cardiac deaths among young adults, routine heart screenings at the school level, and public health campaigns promoting healthy lifestyles to address the growing burden of cardiovascular diseases. On Karnataka CM Siddaramaiah speaking on the possible link between the vaccine and heart attack, Dr Ravindranath said that a member of civic society had petitioned the CM. 'There is a belief among people and health professionals that they are linked. So to clear the doubts of the public, he had asked whether the vaccine could cause it. The expert committee did not find a link," he said. 'Need for post-mortem' Dr Ravindranath stressed on the need for post-mortem for cases of heart failures, registry of sudden cardiac deaths of youngsters, health checks of high school children to discern heart-related issues. On the Hassan case, he said, 'We have asked for details and sent a questionnaire to the local health officials to understand what happened there…Compared to Western countries, heart attacks take place in India 10 years younger. We have seen a 15 per cent increase in youngsters coming to Jayadeva to check on their heart function." Get breaking news, in-depth analysis, and expert perspectives on everything from politics to crime and society. Stay informed with the latest India news only on News18. Download the News18 App to stay updated! tags : anti covid vaccine cardiac arrest heart attacks news18 specials Location : Bengaluru, India, India First Published: July 07, 2025, 17:15 IST News india No Link Between Covid Vaccine & Sudden Cardiac Deaths: Karnataka Govt Research Amid Hassan Surge
News18
2 days ago
- News18
Spermatorrhoea: Harmless or Harmful? Explaining Nightfall Without Shame
Last Updated: Understanding and managing spermatorrhoea requires a compassionate and informed approach, emphasising self-care and open communication Sex may permeate our popular culture, but conversations about it are still associated with stigma and shame in Indian households. As a result, most individuals dealing with sexual health issues or trying to find information about sex often resort to unverified online sources or follow the unscientific advice of their friends. To address the widespread misinformation about sex, is running this weekly sex column, titled 'Let's Talk Sex'. We hope to initiate conversations about sex through this column and address sexual health issues with scientific insight and nuance. In this article, we will explain all aspects of spermatorrhoea, enabling you to distinguish between myths and reality. In a world where health topics are increasingly discussed openly, it is imperative to address concerns that often linger in the shadows, such as spermatorrhoea, commonly known as nightfall. By shedding light on this subject without stigma, you are encouraged to embrace a more informed and confident perspective, acknowledging that nightfall is a normal part of human biology and development. Spermatorrhoea, commonly referred to as 'nightfall," is a natural physiological phenomenon predominantly observed in adolescent males and young adults. It involves the involuntary ejaculation of semen during sleep, often linked to erotic dreams or fantasies. This occurrence is a normal part of male puberty, a period marked by significant hormonal changes and sexual maturation. Despite its prevalence, the topic of nightfall is frequently shrouded in misconceptions and shame, making it essential to shed light on its nature and implications. At its core, spermatorrhoea is a result of the body's reproductive system functioning as it should. During puberty, the testes ramp up the production of testosterone, the hormone responsible for many male characteristics, including the maturation of sperm. As the body adjusts to this surge in hormones, nightfall becomes a mechanism for relieving the reproductive system of excess sperm. It's akin to a pressure-release valve, ensuring the sperm production process doesn't reach an overflow. COMMON CAUSES OF SPERMATORRHOEA Hormonal Imbalances: Spermatorrhoea, often referred to as nightfall, can be influenced by various factors, one of which is hormonal imbalances. Testosterone and other hormones play a crucial role in regulating sexual health. When these hormones are disrupted, whether due to puberty, stress, or medical conditions, they can lead to more frequent episodes of nightfall. It's essential to understand that hormonal fluctuations are a natural part of development, yet they can sometimes indicate underlying health issues if experienced excessively. Psychological Factors: Another significant contributor to spermatorrhoea is the realm of psychological influences. Stress and anxiety are common culprits, as they can elevate levels of physical arousal and lead to involuntary emissions during sleep. Moreover, psychological factors such as sexual fantasies or guilt associated with sexual thoughts can exacerbate the frequency of nocturnal emissions. By acknowledging these influences, individuals can better approach their mental well-being, potentially reducing the occurrence of nightfall. Lifestyle and Dietary Habits: Lifestyle choices and dietary habits can also impact the frequency of spermatorrhoea. A diet low in essential nutrients like zinc and magnesium, combined with sedentary lifestyles, can affect hormonal balance and increase the likelihood of nightfall. Additionally, excessive consumption of stimulating substances such as caffeine and alcohol might lead to more frequent nocturnal emissions. By adopting a balanced diet and engaging in regular physical activity, one can foster a healthier body and potentially mitigate the intensity or frequency of spermatorrhoea. Lack of Sexual Activity: Lastly, a decrease in regular sexual activity can lead to an increase in spermatorrhoea incidents. The body naturally seeks to expel excess semen when ejaculation does not occur through regular means. Understanding this can help normalize the conversation around nocturnal emissions and encourage a healthier, more informed perspective on sexual health. IS SPERMATORRHOEA HARMLESS OR HARMFUL? While spermatorrhoea is generally considered to be a benign occurrence and part of normal male physiology, it can sometimes cause concern or embarrassment for those experiencing it. From a medical standpoint, nightfall is not inherently harmful. It does not lead to physical health problems and is not indicative of any underlying medical condition. However, if excessive, it might be an indicator of heightened sexual tension or anxiety, which could benefit from attention and management. The psychological impact of spermatorrhoea should not be underestimated. Cultural and societal attitudes can often imbue this natural process with unwarranted shame or anxiety. Emphasising a supportive and educational approach is essential to dismantle these negative perceptions. Encouraging open conversations about nightfall can help individuals understand that it is a normal bodily function, reducing the stigma associated with it. In conclusion, spermatorrhoea is a largely harmless phenomenon that plays a role in the body's natural functioning. Promoting awareness and dispelling myths can pave the way for acceptance and understanding, ensuring that individuals experiencing nightfall do so without shame or undue concern. Embracing a positive, informed perspective on spermatorrhoea fosters a healthier, more supportive environment for everyone. EFFECTIVE WAYS TO MANAGE SPERMATORRHOEA Lifestyle Adjustments: Managing spermatorrhoea often starts with subtle lifestyle changes. A balanced diet, regular exercise, and adequate sleep can significantly affect the frequency and intensity of nocturnal emissions. Foods rich in vitamins, minerals, and antioxidants can bolster overall health and stabilize hormones. Regular physical activity not only helps in maintaining a healthy body weight but also promotes better sleep patterns, which can reduce the occurrences of nightfall. Stress Management: Stress and anxiety can exacerbate the frequency of spermatorrhoea. Engaging in relaxation techniques such as meditation, deep-breathing exercises, and yoga can help in alleviating stress. These practices not only calm the mind but also enhance self-awareness, helping individuals understand and control their bodily responses more effectively. Medical Consultation: If spermatorrhoea becomes a source of distress or significantly affects daily life, consulting with a healthcare professional is advisable. A doctor can provide personalized advice and, if necessary, recommend treatments or therapies to manage symptoms. It's important to approach this conversation without shame, as healthcare providers are equipped to help with such concerns. Understanding and managing spermatorrhoea requires a compassionate and informed approach, emphasising self-care and open communication. By approaching the topic without stigma, you empower yourself and others to engage in open, informed discussions that can dispel myths and reduce unwarranted anxiety. Encouraging dialogue with healthcare professionals further demystifies the subject, ensuring that any underlying concerns are properly addressed. Ultimately, embracing a perspective rooted in knowledge and acceptance not only enhances personal well-being but also fosters a broader cultural shift towards more open conversations about sexual health. About the Author Prof (Dr) Saransh Jain First Published:
News18
4 days ago
- News18
Wegovy Here, Ozempic Next: Big Focus On India's Obesity & Diabetes Crisis, Says Novo's Cai
India is among the top two countries in terms of type 2 diabetes cases and third in terms of obesity; hence, the need for weight loss and anti-diabetic drugs is huge Danish drugmaker Novo Nordisk is working to bring its blockbuster drug Ozempic to India 'as soon as possible", Dr Yan Cai, senior vice president of clinical development, medical affairs, and regulatory affairs for international operations, told News18. Reaffirming the Danish drugmaker's commitment, she noted that India is among the top three countries globally in terms of both obesity and type 2 diabetes prevalence, making it a high-priority market. 'I can reassure that India is a very important market for us. With a large population living with type 2 diabetes, we are committed to bringing Ozempic to India. Wegovy and Ozempic serve different populations—Ozempic is for managing diabetes, while Wegovy is for weight loss," Dr Cai told News18 in an exclusive interaction. When asked about the timelines planned for the launch of Ozempic, she said, 'as soon as possible… it is our commitment." Ozempic, originally developed for type 2 diabetes, shot to global fame as a weight loss sensation—fuelled by Hollywood celebrity endorsements and off-label use. Its surging demand has made it one of the world's best-selling drugs, breaking revenue records and reshaping the global obesity and diabetes treatment market. Talking about the relevance of Wegovy for the Indian market, Cai said, India ranks third globally—after the US and China—in obesity prevalence, with over 200 million people estimated to be obese. 'It is also among the top two countries in terms of type 2 diabetes cases. The magnitude of these conditions is huge. We will continue to offer innovative treatments to help people live healthier lives," she said. According to Dr Cai, Wegovy has proven clinical evidence showing it reduces risks related to heart disease, including stroke and myocardial infarction. 'It is the only anti-obesity drug that provides both weight loss and cardiovascular benefits. For people living with obesity or overweight—and especially those with a history of cardiovascular disease—it offers protective benefits," she said. Wegovy is based on semaglutide, the same molecule used in Ozempic. Dr Cai explained that the molecule has a long history and has been used by over 33 million people worldwide. 'Semaglutide has been tried and trusted over the years in terms of safety. Its profile is well understood," she added. She said Novo Nordisk has been a pioneer in the field of obesity treatment, having started research over 25 years ago. 'With Wegovy now launched and Ozempic in the pipeline, the company sees India as a core focus for future medical innovation." 'We will continue to provide treatments that make a meaningful difference. The scale of obesity and diabetes in India calls for urgent and sustained efforts—and we're committed to being part of the solution." How Wegovy works—The science and the journey Semaglutide is part of a drug class known as GLP-1 receptor agonists. It works by acting on receptors in the brain to suppress appetite, particularly the desire for fatty food. 'We have solid data from both human and animal studies showing reduced cravings. People feel full earlier, eat less, and some patients also tell us that they start choosing healthier foods—like salads—on their own," said Cai. 'It's not just about 'eat less, walk more.' Obesity is a complex disease that needs to be managed holistically—with medication, lifestyle changes, exercise, and an overall support system." She emphasised that Wegovy helps balance energy intake and expenditure. 'It helps control cravings and hunger. People respond differently—some experience rapid weight loss, while others lose weight more gradually." Journey of a patient on Wegovy Starting Wegovy requires a careful dose titration process. Patients typically begin on a low dose, which is gradually increased every four weeks under medical supervision. Some individuals may experience gastrointestinal side effects, such as nausea, especially in the early weeks. 'These side effects are usually mild and transient, and they are a natural reaction to this drug class. Around 50–60% of patients don't experience any symptoms at all," Cai noted. 'Most important is not to drop off too soon. The body adjusts over time." Patients are advised to stay at the same dose for four weeks to allow their body to adapt. Based on Novo Nordisk's data and Dr Cai's own experience, 50% of patients stay at 1.7 mg, while 20–30% titrate up to 2.4 mg, which is the highest dose. 'Cardiovascular benefits kick in at higher doses. My advice is to work with your doctor to find the right dose and continue long enough to receive the full benefit. Cardiovascular improvements can be seen as early as 20 days into treatment, with more visible weight loss beginning around 12 to 16 weeks." In clinical studies, 80–90% of patients achieved clinically significant weight loss, defined as more than 5% of body weight. 'More impressively, over 30% of patients lost more than 20% of their body weight within 6 to 8 months of starting treatment." Is this the right price for Indian market? Wegovy is currently priced between Rs 17,000 and Rs 26,000 per month for five doses. Replying to the question on affordability and price-sensitive Indian consumers, Cai said, 'Novo Nordisk has introduced an India-specific pricing model to make the drug more accessible." top videos View all 'We have ensured that the first three dosing categories are priced the same, so patients don't face financial hurdles early in their treatment. This allows them to sustain the therapy without additional burden," Cai explained. She added that Novo Nordisk is also developing new innovations to target different segments of patients in India, with future drugs to be priced accordingly, hinting that those who cannot afford this treatment can expect other new-age drugs from the company's portfolio in the coming years. Get breaking news, in-depth analysis, and expert perspectives on everything from politics to crime and society. Stay informed with the latest India news only on News18. Download the News18 App to stay updated! tags : diabetes health Obesity Weight Loss Location : New Delhi, India, India First Published: July 05, 2025, 08:00 IST News india Wegovy Here, Ozempic Next: Big Focus On India's Obesity & Diabetes Crisis, Says Novo's Cai | Exclusive
