Zeenat Parween, Correspondent, India Pharma Outlook
Both are semaglutide — same molecule, same manufacturer (Novo Nordisk). Ozempic is approved for type 2 diabetes at up to 2 mg weekly. Wegovy is approved for chronic weight management at 2.4 mg weekly, reached via a 16-week dose escalation starting at 0.25 mg. The higher dose is not arbitrary — the dose-response curve for weight loss is steep. Using Ozempic off-label for obesity delivers some benefit, but not the full obesity-indicated effect.
The STEP programme generated the most comprehensive obesity drug dataset in decades. STEP 1 (NEJM, 2021) enrolled adults with BMI ≥30 on semaglutide 2.4 mg for 68 weeks alongside lifestyle counselling:
14.9 percent mean body weight reduction (vs. 2.4 percent on placebo) — STEP 1
69–79 percent of participants lost ≥10 percent body weight across STEP 1, 3, 4, 8
15.2 percent weight loss maintained at 104 weeks — STEP 5 two-year data
20.7 percent weight loss with investigational 7.2 mg dose — STEP UP (2025 ADA)
Approved for adults with BMI ≥30 (obesity), or ≥27 (overweight) with at least one weight-related complication — type 2 diabetes, hypertension, dyslipidaemia, or sleep apnoea. In March 2024, the FDA added a cardiovascular indication: the SELECT trial (17,500 participants) showed a 20 percent relative reduction in major cardiovascular events in patients with pre-existing disease. Semaglutide is now as much a cardiovascular drug as a weight-loss drug.
"Semaglutide presents a timely opportunity to provide an effective solution for the growing obesity and diabetes burden in India," said Vikas Gupta, CEO of Alkem Laboratories.
Two conditions generating significant clinical interest in India: PCOS affects an estimated 20–22 percent of Indian women of reproductive age. Early data show semaglutide improves insulin sensitivity, reduces androgens, and helps restore menstrual regularity. And for metabolic dysfunction-associated steatotic liver disease (MASLD) — which affects ~40 percent of Indian adults with type 2 diabetes — phase 2 data demonstrate reductions in liver fat and histological improvement. Phase 3 trials are ongoing.
Semaglutide's side effect profile is well-characterised and, for most patients, manageable. The key is understanding that the gastrointestinal complaints are largely dose-dependent and time-limited.
Nausea — the most common complaint, reported in approximately 44 percent of semaglutide participants vs. 16 percent on placebo in STEP 1. Peaks during dose escalation and typically resolves within 4–8 weeks of reaching a stable dose. Eating smaller portions, avoiding high-fat or spicy food, and not lying down immediately after eating significantly reduce severity.
Vomiting — occurs in around 24 percent of patients, again most pronounced during escalation. Often pairs with nausea. If vomiting is persistent beyond the initial weeks, the dose escalation schedule should be slowed.
Diarrhoea — reported in approximately 30 percent of participants. Usually mild and self-limiting. Staying hydrated is the primary management strategy.
Constipation — counterintuitively, slowed gastric emptying can also cause constipation, particularly as the drug's effects cascade down the gastrointestinal tract. Increased fibre and fluid intake help.
Gallbladder disease — one of the more serious but less discussed risks. Gallbladder-related disorders, mostly gallstones (cholelithiasis), were reported in 2.6 percent of semaglutide participants vs. 1.2 percent on placebo in STEP 1. Rapid weight loss of any cause increases gallstone risk, and semaglutide is no exception. Patients with a history of gallstones should be monitored.
"The entry of generic semaglutide will unlock significant latent demand, providing a strong boost to an already expanding market," according to Neeraj Sharma of OneSource Specialty Pharma.
Semaglutide carries the FDA's most serious caution — a black box warning — for thyroid C-cell tumours (medullary thyroid carcinoma). This originates from rodent studies at supratherapeutic doses. Human thyroid C-cells express GLP-1 receptors at far lower densities; decades of GLP-1 agonist use have not produced a confirmed human MTC signal. Nevertheless, semaglutide is contraindicated in patients with a personal or family history of MTC or MEN 2 syndrome.
The STEP 1 extension answered this bluntly: patients who lost a mean of 17.3 percent regained 11.6 percentage points within 52 weeks of stopping — a net maintained loss of just 5.6 percent. The weight comes back because obesity is a chronic condition; the biological drivers of weight gain reassert themselves when pharmacological suppression ends. The clinical community is increasingly modelling semaglutide like a statin: long-term therapy for a chronic condition, not a finite course.
During the global shortage (2022–2024), unregulated compounding pharmacies sold semaglutide-containing injections — many with inaccurate doses or contamination risks. In India today, the affordable alternatives are CDSCO-approved generics from regulated manufacturers, not compounded products. Sun Pharma's Noveltrast and Sematrinity, Natco's vial formulation, and Dr. Reddy's generic are manufactured to regulatory standards with full pharmacovigilance obligations. Unregulated online products remain a genuine patient safety risk.
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