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Should Generic Weight-Loss Medications Be Classified as Schedule H and Available Only Through Prescription? Insights from an AIIMS Endocrinologist

With the recent influx of generic semaglutide brands following the expiration of the patent held by the pharmaceutical company Novo Nordisk, the challenge now lies in effectively weighing the medication’s benefits for obesity against its potential misuse for cosmetic weight loss, according to Dr. Nikhil Tandon, an endocrinology professor and head of research at the All-India Institute of Medical Sciences in Delhi. He describes the enhanced availability of the drug as a “double-edged sword.”

The misuse of semaglutide has become more prevalent, particularly through online pharmacies and wellness clinics, especially following the introduction of more affordable alternatives, which are sometimes accessed without a prescription. Previously, such misuse was less common due to the high costs associated with the drug.

This trend raises significant concerns, as the administration of semaglutide requires careful patient selection, appropriate dosing, and ongoing monitoring. The potential for misuse primarily for aesthetic weight loss, rather than for legitimate medical reasons, is alarming. It is crucial to note that semaglutide should not be viewed as a substitute for necessary lifestyle modifications. Its effectiveness is often limited and temporary without accompanying changes in diet and exercise, and it may lead to muscle loss alongside fat loss.

Using semaglutide without proper medical supervision poses serious risks, particularly for those pursuing rapid weight loss for cosmetic reasons. These medications are intended for patients with diabetes or obesity who require precise dosing and monitoring. Inadequate oversight can lead to severe complications such as pancreatitis, acute kidney injury, extreme dehydration due to gastrointestinal side effects, gallbladder issues, and even vision impairments.

Long-term benefits of semaglutide are closely linked to lifestyle changes, so unsupervised usage often results in temporary weight loss followed by regaining weight. Furthermore, rapid weight loss without medical guidance can result in nutritional deficiencies, loss of muscle mass, imbalances in electrolytes, and increased cardiovascular strain. The perception that these drugs provide “quick fixes” can obscure the associated risks and create a false sense of security.

Given the vast target population in India, there is an urgent need for stringent enforcement of prescription regulations, particularly regarding online pharmacies and wellness clinics. This enforcement should be complemented by regular audits, digital validation of prescriptions, and accountability measures for pharmacists involved in dispensing medications.

Additionally, it is essential to combat misleading advertising and enhance pharmacovigilance reporting.

Ultimately, the safety of patients will rely on a collaborative approach involving clinical accountability, regulatory oversight, and public awareness campaigns.

Long-term usage of semaglutide has been associated with various significant adverse effects that necessitate careful monitoring.

Serious gastrointestinal complications have been observed, leading to hospitalizations in over 60% of severe cases. Furthermore, semaglutide may elevate the risk of pulmonary aspiration during surgical procedures due to delayed gastric emptying.

There is also some evidence suggesting a link between semaglutide and ocular complications such as non-arteritic anterior ischemic optic neuropathy, with studies indicating a higher occurrence among users compared to non-users, although a direct causal relationship has yet to be established. Additionally, progression of diabetic retinopathy—a condition resulting from elevated blood sugar levels that harms the retina—has been noted in certain trials, especially among high-risk patients, although results have been inconsistent.

Rare but serious instances of acute pancreatitis have been reported, with some cases resulting in life-threatening conditions after extended use. Acute kidney injury has also been noted, particularly in individuals with dehydration or pre-existing kidney issues. Disorders related to the gallbladder, such as cholecystitis and gallstones, may present a risk that correlates with dosage and duration of use.

In summary, while semaglutide demonstrates effectiveness, it is vital to prioritize long-term safety monitoring.

Anonna Dutt serves as a Principal Correspondent at the Indian Express, focusing on health-related topics. Her reporting encompasses a wide range of subjects, including the growing challenges posed by non-communicable diseases like diabetes and hypertension, as well as issues related to infectious diseases. She has extensively covered the government’s management of the Covid-19 pandemic and has closely monitored the vaccination campaign.

Dutt’s investigative work has prompted the city government to invest in advanced testing options for underprivileged populations and to acknowledge discrepancies in their official reports.

In addition to health reporting, she actively follows India’s space program, having written about significant missions such as Chandrayaan 2 and 3, Aditya L1, and Gaganyaan.

She was among the inaugural group of eleven media fellows with the RBM Partnership to End Malaria and participated in a short-term program on early childhood reporting at Columbia University’s Dart Centre. Dutt holds a Bachelor’s Degree from the Symbiosis Institute of Media and Communication in Pune and a PG Diploma from the Asian College of Journalism in Chennai. She began her journalism career with the Hindustan Times.

Outside of her professional endeavors, she enjoys practicing her French skills with Duolingo and occasionally indulges in dancing.


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