Should generic weight-loss drugs be Schedule H, only to be sold on doc prescription? AIIMS endocrinologist explains

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This is a serious concern because these drugs need careful patient selection, dose adjustment and monitoring. (File)With generic semaglutide brands flooding the market last month — after the innovator pharmaceutical giant Novo Nordisk lost its patent — balancing the benefits of the medicine for obesity against its misuse for cosmetic purposes to shed a few kilos is a real challenge, says Dr Nikhil Tandon, professor of endocrinology and head (research) at the All-India Institute of Medical Sciences, Delhi. He calls the improved access to the drug a “double-edged sword.”ARTICLE CONTINUES BELOW VIDEONow that the drug is off-patent, are you witnessing misuse or over-the-counter access to it?Misuse of semaglutide is increasingly being seen through online pharmacies and wellness clinics, more so with the recent availability of cheaper available options, sometimes without a prescription. Due to cost constraints, it was not very frequently seen till now.This is a serious concern because these drugs need careful patient selection, dose adjustment and monitoring. There is also a risk of inappropriate use for cosmetic weight loss rather than medical need. Importantly, semaglutide is not a replacement for lifestyle changes. Without proper diet and exercise, its benefits are limited and often temporary. And, it can also cause muscle loss along with fat loss.What happens when people seek these drugs for rapid cosmetic weight-loss rather than medical necessity?Unsupervised use of semaglutide can be very dangerous, especially for individuals seeking rapid cosmetic weight loss. These drugs are designed for carefully selected patients with diabetes or obesity, where dosing, monitoring and gradual titration are critical. Without supervision, people risk serious complications such as pancreatitis, acute kidney injury, severe dehydration from gastrointestinal side effects, gallbladder disease and even vision problems.Any long-term benefits of semaglutide are tightly linked to concurrent lifestyle interventions, so unsupervised use often results in temporary results followed by rebound weight gain. Moreover, rapid weight loss without medical oversight can lead to nutritional deficiencies, muscle mass loss, electrolyte imbalances and cardiovascular stress. The perception of these drugs as “easy fixes” can mask these risks and create a false sense of safety.From a policy and regulatory standpoint, what additional safeguards would you recommend?As the target population is very large in India, there is an urgent need for strict enforcement of Schedule H prescription norms, particularly across online pharmacies and wellness clinics. This should be supported by periodic audits, digital prescription validation systems and accountability of dispensing pharmacists.Additionally, curbing misleading advertisements and strengthening pharmacovigilance reporting are critical.Story continues below this adUltimately, patient safety will depend on a combined effort of clinical responsibility, regulatory vigilance, and public education.What about long-term safety? Can the drug be used for prolonged periods?Long-term use of semaglutide has been associated with several important adverse effects that require monitoring.Serious gastrointestinal complications have been reported, with hospitalisations in over 60% of severe cases. Semaglutide may also increase the risk of pulmonary aspiration — stomach content going into the airways or the lungs — during surgery due to delayed gastric emptying.There is also some evidence linking semaglutide to eye complications such as non-arteritic anterior ischemic optic neuropathy, with studies showing a higher incidence in users compared to non-users, although causation is not yet confirmed. Progression of diabetic retinopathy — a complication of high blood sugar levels that damages the retina — has also been observed in some trials, particularly in high-risk individuals, though findings remain inconsistent.Story continues below this adRare but serious cases of acute pancreatitis have been reported, including life-threatening outcomes after prolonged use. Additionally, acute kidney injury has been described, especially in patients with dehydration or pre-existing kidney disease. Gallbladder disorders such as cholecystitis and gallstones appear to have a possible dose- and duration-related risk.Overall, while semaglutide is effective, long-term safety monitoring is essential.Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More © The Indian Express Pvt LtdTags:weight loss