Prescription Guidelines for GLP-1 Incretin Therapies in India

1. Statutory Classification under the Drugs and Cosmetics Act

In India, advanced metabolic drugs including Semaglutide (Ozempic, Wegovy) and Tirzepatide (Mounjaro) are regulated under the Central Drugs Standard Control Organisation (CDSCO). They are designated as prescription-only therapeutic agents (Schedule G / Schedule H).

Dispensing these medications without a verified prescription from a Registered Medical Practitioner (RMP) or specialist endocrinologist is a violation of Indian pharmacy law.

2. Mandatory Pre-Treatment Diagnostic Workup

Prior to initiating incretin-based therapy, a supervising physician must evaluate the patient's metabolic baseline to confirm indication and rule out contraindications:

• Glycemic Evaluation: Fasting Plasma Glucose and HbA1c to assess glucose regulation.
• Renal & Hepatic Function: Serum Creatinine, Estimated GFR (eGFR), SGOT/SGPT, and Bilirubin to confirm safe clearance.
• Lipid Profile: Baseline Total Cholesterol, Triglycerides, HDL, and LDL.
• Thyroid & Endocrine History: Screening to rule out a personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Pancreatic History: Confirming no prior episodes of acute or chronic pancreatitis.

3. Telehealth Consultation & Prescription Renewal Standards

Under the Telemedicine Practice Guidelines issued by the National Medical Commission (NMC) of India, registered clinicians may evaluate patients via video teleconsultation, review diagnostic lab reports, and issue digitally signed e-prescriptions.

Follow-up consultations are typically scheduled every 4 to 8 weeks to monitor dose titration tolerance, track weight and metabolic markers, and adjust maintenance therapy safely.