What semaglutide (generic) products such as Ozempic (semaglutide) injectable and Rybelsus (semaglutide) oral are available in India, and what are their typical costs?

Semaglutide Availability and Cost in India

Oral semaglutide (Rybelsus) and injectable semaglutide (Ozempic) are both available in India, with oral semaglutide representing the first GLP-1 receptor agonist approved for oral administration and offering a potentially more cost-effective option compared to Western markets. 1, 2

Available Formulations in India

Injectable Semaglutide (Ozempic)

• Ozempic subcutaneous injection is available in India following its approval for manufacturing and marketing in March 2018, administered as a once-weekly injection for type 2 diabetes management. 3
• The injectable formulation is indicated as add-on combination therapy with other glucose-lowering agents (including insulin) or as monotherapy when diet and exercise do not provide adequate glycemic control. 4

Oral Semaglutide (Rybelsus)

• Rybelsus tablets are available in India in three strengths: 3 mg, 7 mg, and 14 mg, representing the first oral GLP-1 receptor agonist formulation worldwide. 3
• The oral formulation uses sodium N-(8-[2-hydroxybenzoyl]amino) caprylate (SNAC) as an absorption enhancer to overcome the challenges of peptide absorption in the acidic stomach environment. 4, 3
• Oral semaglutide is indicated for type 2 diabetes when diet and exercise are inadequate, either as add-on therapy or as monotherapy in patients intolerant to metformin. 4

Cost Considerations in India

Comparative Pricing

• The cost of semaglutide in India is reported to be lower than other GLP-1 receptor agonists in Western markets, potentially mitigating the economic burden that appears particularly high among the Indian population with diabetes. 2
• In Western markets, the average wholesale price for a 30-day supply of semaglutide ranges from approximately $1,557 to $1,619, but Indian pricing is expected to be substantially lower. 5

Economic Implications

• The lower cost profile of oral semaglutide in India may improve accessibility compared to injectable GLP-1 receptor agonists, addressing medication adherence challenges related to both cost and route of administration. 2
• The economic burden of diabetes management is particularly significant in India, making cost-effective treatment options crucial for widespread adoption. 2

Clinical Efficacy in Indian Context

Evidence from Clinical Trials

• The 14 mg oral semaglutide dose demonstrated superior efficacy compared to placebo and active comparators (empagliflozin, sitagliptin, and liraglutide) in global PIONEER trials for lowering HbA1c, reducing body weight, and achieving HbA1c targets below 7%. 1
• Efficacy was similar in Asian populations within the PIONEER trials, though no separate data exists specifically for Indians due to low participant numbers in the registration studies. 1

Real-World Data Gap

• Currently, there is no real-world data available on oral semaglutide use in Indian clinical settings, highlighting the need for post-marketing studies to confirm efficacy and safety in this population. 2
• Real-world studies of semaglutide are clearly needed in India given the absence of meaningful data from randomized controlled trials specifically in Indian patients. 1

Safety Profile

Common Adverse Events

• Gastrointestinal intolerance (nausea, diarrhea, vomiting) represents the most commonly observed side effects with oral semaglutide and is the main reason for drug discontinuation, typically being mild-to-moderate and transient. 1, 6
• The safety profile of oral semaglutide is consistent with the GLP-1 receptor agonist drug class, with low risk of hypoglycemia when used as monotherapy. 4, 6

Serious Adverse Events

• Semaglutide increases the risk of biliary disease (cholelithiasis) and should be used with caution in patients at risk for gallbladder disease. 6
• The medication is contraindicated in patients with personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2), based on animal studies showing thyroid C-cell tumors. 5, 6

Clinical Recommendations for Indian Practice

Patient Selection

• Oral semaglutide should be prioritized for Indian patients with type 2 diabetes requiring glycemic control, weight loss, and cardiovascular/renal benefits who prefer to avoid injections or have concerns about medication adherence. 2
• The multitargeted action offers glycemic control, weight reduction, and cardiovascular and renal benefits while potentially enhancing medication adherence through oral administration. 2

Dosing Strategy

• Initiate oral semaglutide at 3 mg daily for 30 days, then increase to 7 mg daily, with optional escalation to 14 mg daily if additional glycemic control is needed after at least 4 weeks. 5
• The medication must be taken on an empty stomach with no more than 120 mL of water, at least 30 minutes before the first food, beverage, or other oral medications of the day. 4

Monitoring Requirements

• Assess treatment response at 12-16 weeks on the maximum tolerated dose; discontinue if weight loss is less than 5% after 3 months at therapeutic dose. 5
• Monitor for gastrointestinal side effects during dose escalation and assess for signs of pancreatitis or gallbladder disease. 5, 6

Storage and Handling

• Consult the FDA-approved prescribing information and manufacturer's product labeling for accurate shelf life and storage requirements specific to each semaglutide formulation. 7
• Semaglutide formulations typically require refrigerated storage before first use; once in use, pens can be stored at room temperature but should be protected from light and freezing. 7

Common Pitfalls to Avoid

• Do not assume efficacy data from global trials automatically applies to Indian patients without considering potential ethnic differences in drug response; advocate for real-world Indian studies. 1, 2
• Do not prescribe oral semaglutide to patients with symptomatic gallstones or active gallbladder disease, as GLP-1 receptor agonists increase the risk of cholelithiasis and cholecystitis. 5, 6
• Do not overlook the need for proper administration instructions for oral semaglutide, as incorrect timing relative to meals and other medications can significantly reduce absorption and efficacy. 4