Adverse Drug Reaction Monitoring of Semaglutide in India: Impact of Expanding Formulations and Generic Market Entry

Abstract

Semaglutide has become a key therapy for the management of Type 2 Diabetes Mellitus and obesity. In India, the rising burden of metabolic diseases has led to a rapid increase in its use. Recently, with the expiry of patent protection, generic semaglutide has been officially introduced in the Indian market, leading to wider accessibility and reduced cost. Multiple pharmaceutical companies are now offering different formulations, including pre-filled pens, multi-dose pens, vials, and oral tablets. While this expansion improves patient access, it also introduces challenges related to drug safety and consistency. Adverse drug reactions (ADRs) associated with semaglutide are mainly gastrointestinal, but serious reactions such as pancreatitis, renal impairment, gallbladder disease, and worsening diabetic retinopathy have also been reported. In India, factors such as polypharmacy, self-medication, off-label use for weight loss, and variability among generic formulations further increase the risk of ADRs. Differences in drug concentration, delivery systems, and excipients among various generic products may result in variability in pharmacokinetics and pharmacodynamics. This can lead to inconsistent therapeutic outcomes and increased risk of adverse effects, especially when patients switch between brands without proper medical supervision.

The Pharmacovigilance Programme of India (PvPI) plays a vital role in monitoring ADRs; however, underreporting remains a major limitation. With the official launch of multiple generic semaglutide products, there is an urgent need to strengthen ADR monitoring systems.

This review highlights the importance of pharmacovigilance in the Indian context, focusing on formulation variability, generic expansion, and patient safety. Continuous monitoring, regulatory vigilance, and healthcare professional awareness are essential to ensure safe use of semaglutide in India.

Keywords: Semaglutide; Adverse Drug Reactions; India; Pharmacovigilance; Generics; GLP-1 Receptor Agonist; Drug Safety

Citation

Lakshmi Prasanna T, Aruna T, Brattiya K. Adverse Drug Reaction Monitoring of Semaglutide in India: Impact of Expanding Formulations and Generic Market Entry. WebLog J Pharmacol Ther. wjpt.2026.f1104. https://doi.org/10.5281/zenodo.20951128